MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE DAILY 

MEDICAL DEVICE 

INNOVATION 

2010 

WHAT’S NEW AT SELECTED 

DEVELOPMENT-STAGE COMPANIES

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MEDICAL DEVICE INNOVATION 2010 

1 

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Table of Contents 

Company 

Page 

3T Ophthalmics . . . . . . . . . . . . . . . . . . .7, 146 

Aethlon Medical . . . . . . . . . . . . . . . . . . . . . . .8 

AMDL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 

Angel Medical . . . . . . . . . . . . . . . . . . . . . . . . . .11 

Applied Medical . . . . . . . . . . . . . . . . . . . . . .12 

Aspect Medical . . . . . . . . . . . . . . . . . . . . . . .13 

Asthmatx . . . . . . . . . . . . . . . . . . . . . . . . . . .14,16 

ATS Medical . . . . . . . . . . . . . . . . . . . . . . . . . . 18 

Avantis Medical Systems . . . . . . . . . . . . . . 19 

Bioheart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 

BodyViz . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 

Brainsgate . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 

Cameron Health . . . . . . . . . . . . . . . . . . . . . 23 

CapsuTech . . . . . . . . . . . . . . . . . . . . . . . . . . .24 

Cardiac Dimensions . . . . . . . . . . . . . . . . . .26 

CardiAQ Valve Technologies . . . . . . . . . 28 

Cardinal Health . . . . . . . . . . . . . . . . . . . . . . .30 

CardioDX . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 

Case Western University . . . . . . . . . . . . . .32 

Cepheid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 

Chamberlin Group . . . . . . . . . . . . . . . . . . . 35 

Cheetah Medical . . . . . . . . . . . . . . . . . . . . . 37 

CNSystems Medizintechnik . . . . . . . . . . 38 

Cochlear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 

Coherex Medical . . . . . . . . . . . . . . . . . . . . . .41 

Corventis . . . . . . . . . . . . . . . . . . . . . . . . . . . .43 

CVRx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44 

DiFusion Technology . . . . . . . . . . . . . . . . .46 

Diopsys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47 

Draper Laboratories . . . . . . . . . . . . . . . . . .48 

Drexel University . . . . . . . . . . . . . . . . . . . . .49 

Egen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 

Ekos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 

EnteroMedics . . . . . . . . . . . . . . . . . . . . . . . . .52 

Envoy Medical . . . . . . . . . . . . . . . . . . . . . . . .54 

Estill Medical Technologies . . . . . . . . . . .56 

Exmovere . . . . . . . . . . . . . . . . . . . . . . . . . . . .57 

GI Dynamics . . . . . . . . . . . . . . . . . . . . . .59, 60 

GlycoMeds . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 

Harvard University . . . . . . . . . . . . . . . . . . .62 

HealthPartners . . . . . . . . . . . . . . . . . . . . . . .63 

Home Diagnostics . . . . . . . . . . . . . . . . . . . .65 

ImThera Medical . . . . . . . . . . . . . . . . . . . . .66 

InSightec . . . . . . . . . . . . . . . . . . . . . .24, 67, 68 

Invatec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70 

Kansas State University . . . . . . . . . . . . . . .72 

Lawrence Livermore National 

Laboratory . . . . . . . . . . . . . . . . . . . . . . . . .73 

LenSar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74 

Link-It Medical . . . . . . . . . . . . . . . . . . . . . . .75 

Lumalier . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76 

Luminex . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78 

Luminous . . . . . . . . . . . . . . . . . . . . . . . . . . . .79 

Mardil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80 

Medical Designs . . . . . . . . . . . . . . . . . . . . . .82 

Medical Technologies International . . .83 

Medical University of South Carolina . .84 

Micrus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85 

Molecular Detection . . . . . . . . . . . . . . . . . .86 

Nanosphere . . . . . . . . . . . . . . . . . . . . . . . . . .87 

Neochord . . . . . . . . . . . . . . . . . . . . . . . . . . . .88 

NeuroInterventions . . . . . . . . . . . . . . . . . .90 

New York Presbyterian Hospital . . . . . .92 

NIDCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94 

NiTi Surgical Solutions . . . . . . . . . . . . . . .95 

NovoCure . . . . . . . . . . . . . . . . . . . . . . . . . . . .96 

NMT Medical . . . . . . . . . . . . . . . . . . . . . . . . .97 

Nomir Medical . . . . . . . . . . . . . . . . . . . . . .98 

Organ Recovery Systems . . . . . . . . . . . . .99 



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Table of Contents 

Company 

Page 

OrthoDynamix . . . . . . . . . . . . . . . . . . . . . . . .101 

Ossur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102 

Pacific Edge Biotechnology . . . . . . . . . . .103 

Paradigm Spine . . . . . . . . . . . . . . . . . . . . . .104 

PEAK Surgical . . . . . . . . . . . . . . . . . . . . . . . .106 

PLC Medical . . . . . . . . . . . . . . . . . . . . . . . . .108 

Profound Medical . . . . . . . . . . . . . . . . . . .109 

ProUroCare Medical . . . . . . . . . . . . . . . . . .1 1 1 

ReGen Biologics . . . . . . . . . . . . . . . . . . . . . .112 

Sanomedics . . . . . . . . . . . . . . . . . . . . . . . . . .113 

Sansum Diabetes Research Institute . .114 

Sanuwave . . . . . . . . . . . . . . . . . . . . . . . . . . . .115 

Second Sight Medical Products . . . . . . . .116 

Sensimed . . . . . . . . . . . . . . . . . . . . . . . . . . . . .117 

SeraCare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .119 

SFC Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . .121 

Shape Medical Systems . . . . . . . . . .122, 123 

Stentys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124 

Sunshine Heart . . . . . . . . . . . . . . . . . . . . . .125 

SuperSonic Imagine . . . . . . . . . . . . . . . . . .126 

superDimension . . . . . . . . . . . . . . . . . . . . .127 

SynergEyes . . . . . . . . . . . . . . . . . . . . . . . . . .129 

TBI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .130 

Texas Heart Institute . . . . . . . . . . . . . . . . .131 

Thermogenesis . . . . . . . . . . . . . . . . . . . . . .133 

Transoma Medical . . . . . . . . . . . . . . . . . . .134 

University of Arkansas . . . . . . . . . . .135, 137 

University Children’s Hospital . . . . . . . .138 

University of Michigan . . . . . . . . . . . . . . .139 

University of Toronto . . . . . . . . . . . . . . . .140 

Urovalve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .141 

US Endoscopy . . . . . . . . . . . . . . . . . . . . . . . .143 

Ventus Medical . . . . . . . . . . . . . . . . . . . . . .144 

Vesticon . . . . . . . . . . . . . . . . . . . . . . . . . . . . .146 

VisionCare . . . . . . . . . . . . . . . . . . . . . . . . . . 148 

Vision Center at Children’s Hospital . .149 

Vital Therapies . . . . . . . . . . . . . . . . . . . . . . .150 

VisEn Medical . . . . . . . . . . . . . . . . . . . . . . . 151 

Wake Forest University . . . . . . . . . . . . . . .152 

Weill Cornell Medical College . . . . . . . . .153 

Wicab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 




5 

Innovative new companies 

provide the lifeblood of med-tec 

Of the hundreds of front-page stories published each year in Medical Device Daily, the 

largest response often is accorded those in which our writers report on the product-related 

activities of development-stage and emerging companies. These stories provide an insight 

into the innovative activities occurring at firms that are not yet household names. 

While news in this sector often is skewed toward corporate biggies such as Johnson & 

Johnson, Medtronic, Boston Scientific, Baxter Healthcare, St. Jude Medical and others – and that 

certainly was true during 2009 — we also try to keep a sharp eye out for the activities of socalled 

“little guys.” We enjoy being among the first to report on companies being built on ideas 

that may turn into the medical technology breakthroughs of tomorrow. 

Those ideas, and the future promises they hold, spark the investments that keep this 

industry moving. Those investments — coming from financial “angels,” venture capitalists, 

corporate collaborators or the public markets that have started to re-open for those firms 

deigned to have the right stuff — fuel the climb from concept to commercialization. 

The ideas that still are standing after running the harrowing gauntlet of testing, trials, regulatory 

scrutiny and increasingly important reimbursement issues may go to market as products 

in clinicians’ hands. Whether the eventual setting of such products’ use is hospitals, 

physicians’ offices or diagnostic labs, the final product marks the end of a long journey of 

development and the beginning, it is hoped, of solving a clinical need. 

In a time of potential sea changes in the healthcare industry due to new leadership in 

Washington, one thing that still has not changed is the value of innovation to the med-tech 

field and to humanity as well. 

No matter what, an increasingly large aging population in the U.S. and worldwide will continue 

to demand the latest and greatest innovations in healthcare. Other long-term trends, 

such as large unmet medical needs and increasing prosperity in emerging markets, spell 

growing demand for healthcare and med-tech products. Additionally, larger companies that 

have recently slashed their R&D budgets may increasingly rely on these innovative small companies 

for their breakthrough products of the future. 

These stories by MDD staff writers Omar Ford, Rob Kimball, Don Long, Amanda Pedersen, 

and Lynn Yoffee offer insight into some of the innovative activities taking place at the young 

or modestly sized older companies whose products help fill the pipeline of new technology. 

As the daily news service of the med-tech industry, Medical Device Daily comes in contact 

with both people and product ideas from companies across the entire spectrum of the sector 

– from the smallest start-up to the aforementioned Goliaths. This collection of stories from 

recent issues of Medical Device Daily touch on some of the most interesting developments 

that have caught our attention during the past year. 

— Holland Johnson, Managing Editor 

February 2010 



6 





A tiny silicone cup improves 

drug delivery for eye diseases 

By LYNN YOFFEE 

Medical Device Daily Staff Writer 

Physicians and researchers have, for years, tried to get 

drugs into the eyes without a great deal of success. Much of 

it washes away and also gets absorbed into the body’s system. 

A tiny silicone cup sealed to the outer surface of the 

eye may provide a more effective method for the delivery 

of medicines for retinal and vitreous diseases such as cancer, 

macular degeneration and diabetic retinopathy. 

“We can get higher levels of drug in the eye with oneone-hundredth 

of the dose we’d get giving it systemically,” 

A. Linn Murphree, MD, director of the Retinoblastoma 

Program in The Vision Center at Childrens Hospital Los 

Angeles told Medical Device Daily. “So the patient would 

get much higher levels with lower exposures and virtually 

none getting into the systemic circulation.” 

Murphree’s work centers on treating retinoblastoma, a 

cancer of the retina that typically afflicts children, which 

calls for chemotherapy. Current treatment involves intravenous 

delivery. 

“We wanted any type of system to get chemotherapy 

into the eye in a better way,” Murphree said. So he and two 

other colleagues invented silicone cup, which differs from 

any sort of implant or insert currently available because it’s 

non-invasive and is attached temporarily with a bioadhesive 

glue. 

“Think about a coffee cup with a flattened rim,” 

Murphree said. “When you turn it upside down, it has a wide 

flange in contact with the eye and a bioadhesive is used on 

the lip.” 

The device can be reloaded with medication as needed. 

Known as the episcleral drug reservoir, it holds the 

potential to fundamentally change the delivery of medications 

for all eye diseases, according to a report delivered by 

Murphree last week at the Association for Research in 

Vision and Ophthalmology (ARVO) Summer Eye Research 

Conference on Ophthalmic Drug Delivery Systems in 

Bethesda, Maryland, where he explained that it works like 

an organ-specific transdermal skin patch. 

The cup isolates the medication targeted to the eye 

from being absorbed into the blood stream. It delivers medications 

to the interior of the eye over long periods of time 

up to months. 

Drops, periocular injections and intraocular injections 

are currently used to deliver medications to the eye but 

generally for short periods of time. 

This work is being backed by 3T Ophthalmics (Irvine, 

California), which holds the associated intellectual property 

license. 

The episcleral drug reservoir is inserted under the thin, 

filmy conjunctiva, or covering of the eyeball, to the sclera – 

the fibrous, protective outer layer of the eye. The cup 

administers the drug slowly by passive diffusion through 

the sclera, where it reaches the retina and vitreous. The 

device is so small the patient’s vision is unlikely to be 

affected. 

With preliminary testing complete, Murphree is currently 

developing a protocol for phase I/II clinical trials in 

humans, focused on retinoblastoma, to take place in 2010. 

Murphree’s first focus, retinoblastoma, requires relatively 

large doses to achieve a therapeutic concentration in 

the retina. A byproduct is that the chemo destroys the bone 

marrow and depresses the child’s immune system, often 

leading to secondary infections. All of this delays an effective 

administration of the drug and the ability to treat the 

cancer. 

“Our preliminary research shows that once the cup is 

fitted, the child should be able go home for several weeks. 

Because the drug is being administered directly into the 

eye and not systemically, chemotherapy dosage levels will 

be much lower and the debilitating side effects will be 

reduced,” Murphree said. 

He has tested the device in rabbits and observed they 

didn’t seem to feel discomfort when the cup was attached, 

nor did they experience side effects as they would from 

systemically administered drugs. 

The device is 8 mm to 10 mm with a reservoir that is 

about one-tenth of a millimeter. Liquids, tablets or gels 

could be loaded in the cup. 

“We’ve shown that we can get 30 to 40 times more drug 

this way than if you gave the same amount as an injection,” 

he said. “The difference is that you maintain the concentration 

radiant across the eye wall. Theoretically it could deliver 

drugs as large as Avastin and as small as antibiotics or 

steroids. It can stay on as long or as short a period as you 

want.” 

(This story originally appeared in the Aug. 5, 2009, edition 

of Medical Device Daily) 

7 



8 

Aethlon’s Hemopurifier 

removes H1N1 from blood 



Aethlon Medical’s (San Diego) blood filtration device, 

the Hemopurifier, has successfully removed 96% of H1NI in 

blood plasma samples as reported from an emergency 

study authorized by the U.S. Department of Health and 

Human Services (HHS). 

“At this point we’re in discussions as to what the potential 

next steps might be in terms of clinical programs with 

HHS. We’re watching how H1N1 evolves and there are certainly 

different opportunities in terms of getting approval 

via emergency use authorization or humanitarian use. 

Should H1N1 become virulent, then we think it should be 

something seriously considered,” Aethlon’s chairman/CEO, 

Jim Joyce, told Medical Device Daily. 

Joyce said the tipping point for an early emergency use 

authorization of any type will be if the virus mutates. 

“There are no reports of mutation yet, but you’re seeing 

that the hard-hit population has been people under 25, 

which is concerning because there’s a certain portion of 

that population that should have a robust immune 

response. Researchers are now trying to understand how it 

goes from infection to death in a very short time in children. 

Given these events, there are some initial indications 

[that H1N1 could be mutating], but nothing solid yet.” 

Joyce explained that the Hemopurifier isn’t just a filtration 

device; he calls it as an adjunct and treatment enhancement 

device because it can be used in conjunction with 

common antiviral medication to rid the body of the virus. 

“The concept of enhancing the ability of a drug to be 

effective is no longer theoretical,” Joyce said. “It’s proven. 

There’s a very strong precedent now. Not only can the 

Hemopurifier enhance outcomes, it can do so dramatically.” 

He refers to studies and subsequent data related to the 

Hemopurifier’s use to fight hepatitis-C (HCV), the company’s 

original indication. Potential applications and related 

studies focus on a variety of pathogens that infect the 

blood including HIV, hemorrhagic fever and 

cytomegalovirus. 

But heightened concerns over the H1N1 pandemic led to 

the U.S. government’s move to start testing the filter 

against this new influenza. Joyce said Aethlon was asked to 

ship an undisclosed number of the devices to “a research 

institute” for testing by third-party researchers. 

Why all the secrecy 

“As this disease has grown, there’s sensitivity to organizations 

that are housing the virus, especially if they’re in 

geographically centralized areas,” Joyce said, adding that 

further details of the study are confidential until the HHS 


signs off. 

Researchers involved are expected to publish their 

results in a peer-reviewed journal in the near future. 

What Joyce was able to disclose are some top line data 

results that show the longer the device is used, the more 

effective it is at removing a virus from blood. Hemopurifier 

removed 68% of H1N1 virus from blood plasma in 30 minutes, 

80% of the virus in two hours, and there was a 96% 

reduction of H1N1 observed at six hours. 

Joyce said it’s this feature that will set the Hemopurifier 

apart from its closest competitors, whether used against 

H1NI or HIV. 

“There’s a very important mechanism of how our cartridge 

works,” he said. “It’s selective for removing the virus 

and doesn’t indiscriminately remove particles in the blood 

that are needed. The other factor that’s advantageous is 

that it removes proteins that shed from virus, so we can 

preserve immune cells. We see the benefit in use with 

antivirals because we think it enhances the ability for 

antivirals to work, but we also see it as immunotherapeutic.” 

Asahi Kasei Medical (Tokyo) has developed a similar 

blood filtration device called Planova filters, and the company 

has even launched a direct-to-consumer website touting 

its benefits in chronic hepatitis treatment as approved 

in Japan. But Joyce points out that this device’s potential 

applications are limited because it strips the blood of too 

many components, limiting the amount of time a patient 

could endure the blood cleansing. 

“But what Asahi has done is to validate the concept of a 

treatment enhancement device and we’re looking to follow 

along and improve on that,” he said. 

Hemopurifier employs hollow-fiber dialysis along 

with affinity chromatography to selectively bind envelope 

viruses. The filtration cartridge is able to capture circulating 

viruses, viral proteins and toxins in an effort to 

reduce viral load so that the patient’s natural immunity 

can recover to effectively kill off the infection. But 

Hemopurifier can also be used in conjunction with drugs 

and vaccines. 

Earlier this year, Aethlon reported results of the first 

human study of Hemopurifier to treat HIV. Viral load was 

reduced by 92% in an HIV-infected individual who received 

a total of 12 Hemopurifier treatments administered three 

times a week over the span of one month. 

But the majority of research has been focused on HCV 

with results from various studies that demonstrate robust 

viral load reductions. 

In addition to tackling numerous viral indications, 

Joyce pointed out that Hemopurifier could aid drug 

research because the filter isolates live viruses from the 

blood. 

“Normally researchers are challenged because they 




9 

don’t have the quantities of virus they need,” he said. 

“Usually when it grows in culture, it evolves differently than 

in the body. We could provide quantities of virus from 

patients so that drug companies could examine the various 

strains which would provide better insight into how the 

virus is evolving.” 

(This story originally appeared in the Oct. 22, 2009, 

edition of Medical Device Daily) 



10 


AMDL launches diagnostics 

branch to focus on Onko-Sure 

A Medical Device Daily Staff Report 

AMDL (Tustin, California) a US-based pharmaceutical 

company with major operations in China, reported the 

launch of AMDL Diagnostics (ADI), a new wholly-owned 

subsidiary that will focus on the research, development, 

manufacture and international sales of Onko-Sure AMDL’s 

proprietary, regulatory approved in vitro diagnostic (IVD) 

cancer test. 

The establishment of a separate subsidiary allows AMDL 

to concentrate specific resources to the successful execution 

of that plan. ADI intends to achieve goals set forth in its 

5-year plan by securing adequate financing, significantly 

broadening its distribution network, and continuing to 

research, develop, and commercialize current and future 

diagnostic products. ADI’s management believes sales of 

Onko-Sure test kits are likely to exceed $100 million per 

year by the end of FY2014. Current projections for ADI indicate 

FY2009 sales of nearly $1 million and generating a 

small loss for the year, and sales of nearly $17 million with 

over $13 million in earnings in FY2010. 

With the exception of heart disease, cancer causes more 

deaths than any other medical condition in the world. 

According to the World Health Organization (WHO), cancer is 

rapidly becoming the leading cause of death worldwide and 

expected to overtake heart disease by 2010. Onko-Sure has 

been approved by the FDA for the monitoring of colorectal 

cancer and by Health Canada as a lung cancer screen and 

cancer monitoring tool. Following the introduction of the 

DR-70 (FDP) cancer test in the US and Canada, AMDL intends 

to expand product commercialization to select international 

markets based on other regulatory approvals and plans to 

file for marketing approvals in other areas of the globe. 






Heart attack patients get 

‘Guardian Angel’ with new 

implantable device 

By OMAR FORD 


In the U.S., nearly 35% of the females who are heart 

attack survivors will go into cardiac arrest a second time 

within the same year. Males have a 20% chance of this 

occurring. But one company is hoping to reduce these statistics 

by developing an implantable device that can monitor 

and alert the patient when he or she is on the onset of a 

heart attack. 

Angel Medical Systems (Shrewsbury, New Jersey) 

has developed the AngelMed Guardian – which is currently 

going through a pivotal study now called ALERTS. The 

device will be implanted in 1,000 patients throughout 50 

sites. 

“[Guardian] is implanted like a pacemaker in the 

patient,” Jonathan Harwood Angel Medical Systems COO 

told Medical Device Daily. “It is in the patient and it gives a 

real time stress test of the patient’s heart.” 

The cardiac monitor and alert system is comprised of 

an internal implantable device about the size of a standard 

pacemaker with a lead into the heart, a pager device, and a 

programmer that aids physicians in evaluating heart signals. 

The device is implanted under the skin near the collarbone 

and using a wire placed in the right chamber of the 

heart. Patients wear the pager at all times and are alerted by 

a combination of vibration, beeps, and a flashing light to 

notify them to see their doctor or go immediately to the ER. 

Typically when patients have heart attacks it is the 

result of a blood clot closing one of the three major coronary 

arteries. When this occurs there is a shift in the ST segment 

of the heart signal caused by the electrical difference 

between the portion of the heart muscle fed by the closed 

artery and the rest of the heart that is still receiving oxygen. 

The Guardian IMD is designed to recognize a potential 

heart attack by detecting a shift in the ST segment level of 

a patient’s electrogram sensed using a standard pacemaker 

lead. The ST segment level is continually compared to 

the normal patient electrogram using a patented Angel 

Medical Systems detection algorithm. 

According to the company, if there are three abnormal 

electrical signals that are detected in a row within less than 

two minutes time, the patients will get a warning. 

“It compares the signals to a baseline that is taken over 

a 24 hour period,” Hardwood said. “If there is any change 

then it lets off a signal.” 

Most recently the company reported implanting two 

patients at Memorial Care Heart and Vascular Institute at 

Long Beach Memorial Medical Center (LBMMC; Long 

Beach, California) with Guardian. The center is one of 16 U.S. 

11 

hospitals currently participating in the pilot study for the 

AngelMed Guardian device. 

“A second heart attack within the first year of survival 

is very common and unfortunately, most patients don’t go 

to the emergency room until three hours after symptoms 

start,” said John Messenger, MD at LBMMC in a statement 

“Alerting patients that they need immediate medical attention 

before it’s too late could profoundly change heart 

attack survival rates.” 

Harwood is hopeful of the device and says that it has 

gotten pretty positive response. 

“There are success stories, and this is a huge market 

the device is entering,” he said. 

Harwood pointed out that the market could grow to 

include people who are simply at risk for heart attacks, 

such as diabetics and smokers. 

The Guardian will probably be launched in about two to 

three years in the U.S. for commercial use, depending on 

FDA approval. It already has approval in Brazil and there are 

plans to gain CE mark approval for the system in the near 

future. 

(This story originally appeared in the Sept. 21, 2009, edition 




12 

Applied Medical debuts 

surgical access in Europe 


By JOHN BROSKY 

Medical Device Daily European Editor 

PARIS — A novel device for single-incision surgery from 

Applied Medical (Rancho Santa Margarita, California) 

made its European début at the 111th French Surgery 

Congress. 

The GelPOINT, which won 510(k) approval from the FDA 

in February, goes head-to-head with single-port access 

(SPA) devices from Covidien (Dublin, Ireland), Olympus 

(Tokyo) and Karl Storz (Tuttlingen Germany). 

Yet innovative features of the new Applied Medical port 

create advantages against these established competitors 

and challenge other SPA products with its unique surgical 

approach. 

The current line of SPA devices target the umbilicus as 

the point of entry for scar-less surgery, so called as it 

requires a single incision that is later hidden in the folds of 

the belly button. 

This contrasts with the conventional approach to minimally 

invasive surgery that leaves four puncture holes in 

the patient’s abdomen required by a surgeon to triangulate 

graspers, scissors and the endoscope at the surgical site. 

Patient demand is driving a rapid acceptance of SPA 

with the scar-free belly button approach. 

Within two years of the technique’s introduction in 

2007 by Paul Curcillo, MD, of Drexel University 

(Philadelphia), more than 5,000 SPA procedures have been 

performed in the U.S. alone, rapidly expanding from cholecystectomy 

to diverse applications for organ removal and 

bariatric treatments. 

Yet inserting multiple instruments into the three to four 

ports packed into a narrow SPA device leads to “swordfighting” 

because the surgeon is working along the same 

line with all instruments and no longer can triangulate. 

This instrument clash, also called the “chopsticks 

effect” is not unlike trying to turn a steak on the grill using 

two forks with your wrists tied together, 

Olympus and Karl Storz responded to this challenge 

created by their SPA ports by designing a new line of instruments 

with curved handles, requiring a new level of investment 

in dedicated tools for single-port surgeries. 

Covidien’s solution is to cross the shafts of the instruments 

resulting in the disorienting exercise for surgeons of 

watching left hand actions on the right side of the monitor 

and vice versa for the right hand. 

Applied Medical’s GelPOINT is built on the company’s 

Alexis abdominal retractor, a flexible ring inserted through 

an incision as small as 1.5 cm that atraumatically expands 

soft tissue to expose a wider opening to a surgical site. 

The GelSeal cap is placed on top of the ring creating a 

soft surface giving the surgeon a 360-degree working platform 

above the surgical site inside the abdomen into which 

5 mm access ports can be placed as required to triangulate 

instruments. 

GelPOINT also can be used at any other point on the 

abdomen so that single-incision surgery is not restricted to 

an umbilical access, though this leaves a visible scar up 

between 1.5 cm and 7 cm. 

The GelPOINT assembly includes a stopcock valve to 

maintain insufflation of the patient’s abdomen during surgery. 

The single-use package from Applied Medical for the 

GelPOINT advanced access platform includes four trocars 

with a retaining disk on the distal tip of the cannula that 

stabilizes the tube once it is inserted through the GelSeal 

cap 

The GelSeal cap can be removed during a procedure to 

extract an organ. 

GelPOINT became available in the U.S. in mid- 

September and the company has filed for CE mark 

approval, which Gary Johnson, President of the Surgical 

Group at Applied Medical told MDD he expects to receive 

before the end of October. 

Johnson also confirmed GelPOINT is currently being 

investigated as an access platform for robotic surgery. 

A paper published online in March, 2009 in the 

European Urology Journal authored by Robert Stein from 

the Cleveland Clinic describes the results of 11 laparoendoscopic 

single-site surgeries using GelPOINT with the da 

Vinci Surgical System from Intuitive Surgical (Sunnyvale, 

California). 

Stein et al concluded that the Applied Medical access 

platform provided “adequate spacing and flexibility of port 

placement and acceptable access to the surgical field for 

the assistant, especially during procedures that require a 

specimen extraction incision.” 

(This story originally appeared in the Oct. 5, 2009, edition 





ARS measures effectiveness 

of anti-depressant medications 

By OMAR FORD 


It’s estimated in the U.S. that nearly 15 million people 

experience a depressive disorder every year and that nearly 

17% of adults in the U.S. will experience major depression 

in their lifetime. And in that number research has shown 

that many patients looking to treat their depression won’t 

respond adequately to the first antidepressant treatment 

they are prescribed. 

So finding the right kind of treatment for major depressive 

disorders is often challenging for patients and doctors 

alike, but a new application by Aspect Medical (Norwood, 

Massachusetts) might help eliminate some of the difficulties. 

Results from the clinical study Biomarkers for Rapid 

Identification of Treatment Effectiveness Trial in Major 

Depression (BRITE), show that Aspect’s EEG-based 

Antidepressant Treatment Response indicator, is a significant 

predictor of patient response and remission after one 

week of treatment with the commonly prescribed antidepressant 

escitalopram. The company suggests that ATR has 

the potential to positively impact depression treatment 

outcomes by helping clinicians select the most effective 

antidepressant for each patient early in their treatment. 

The BRITE trial was conducted in collaboration with 

investigators from nine facilities throughout the country 

and saw 375 patients. Their response was defined by 

researchers as a 50% improvement in depression symptoms 

as measured by the Hamilton Depression Rating Scale 

after seven weeks of treatment, and remission was defined 

as recovery from depression after seven weeks of treatment. 

In the study, ATR at one week predicted the response 

and remission with 74% accuracy in subjects treated for 

seven weeks with escitalopram, which was statistically significant. 

These results were then published in the 

September issue of the journal Psychiatry Research. 

“The results of the trial have been reported in various 

scientific sessions, but this is the first peer-review publication 

of these results,” Amy Siegel VP of Strategic Marketing 

for Aspect Medical told Medical Device Daily. “This is pretty 

significant.” 

ATR works by using six sensors to measure electrical 

activity in the brain and translate it into a number between 

0 and 100. Two of the sensors are placed on the ears and the 

rest are placed along the head. The sensors hook up to a 

laptop which measures the EEG. The test can be taken in an 

office setting within 10 to 15 minutes. 

Patients first get readings prior to taking medication, 

then another about a week after the anti-depressant medicine 

is administered. 

The lower the score, derived from the ATR index the 

least likely a patient is to respond to the treatment. 

“You don’t know how someone is going to respond to 

treatments,” Andrew Leuchter, MD a professor of Psychiatry 

at the Semel Institute for Neuroscience and Human 

Behavior at University of California Los Angeles, 

principal investigator for the trial, and chair of Aspect’s 

Neuroscience Advisory Board told MDD. “What ATR does is 

lets us see within one week if patients are going to respond 

to the therapy or not.” 

Leuchter, who helped develop the device at UCLA back 

in 2002 added that, while using ATR on patients doesn’t 

predict the right dose of medication, it does give info on if 

the right medication is being used to treat the illness. 

“BRITE study results suggest that ATR could potentially 

provide the greatest clinical benefit for those patients who 

might be receiving a medication that is unlikely to help 

them. Our results suggest that it may be possible to switch 

these patients to a more effective treatment quickly. This 

would help patients and their physicians avoid the frustration, 

risk and expense of long and ineffective medication 

trials,” said Leuchter. “Research has shown that depression 

patients who do not get better with a first treatment 

attempt experience prolonged suffering, are more likely to 

abandon treatment altogether from lack of efficacy and 

may become more resistant to treatment over time.” 

In the future, the company plans to continue the ATR 

research effort and conduct a multi-year follow-on study of 

ATR called the PRISE-MD study (Personalized Response 

Indicators of SSRI Effectiveness in Major Depression). This 

study will is expected to prospectively evaluate the ability 

of ATR to predict response to escitalopram as well as the 

clinical utility of ATR-directed treatment with escitalopram 

or an alternate treatment with bupropion. Funding for this 

study comes from a grant from the National Institutes of 

Health. 

Phillip Devlin, VP of Emerging Tech at Aspect said that 

the company is currently in talks with the FDA to decide 

what regulatory path it would proceed down to obtain market 

clearance of ARS, but stopped short of saying what that 

clearance might be. 

“This is very promising research,” Devlin touted. 

Based on the findings, the company said it would be realistic 

to expect to see the device commercialized in the 

next five years. 

(This story originally appeared in the Sept. 14, 2009, 


13 



14 

Asthmatx in expedited review 

of asthma device PMA 

By DON LONG 

Medical Device Daily National Editor 

Breathing room. 

That’s what a new device system from Asthmatx 

(Sunnyvale, California) is designed to provide, by preventing 

the airway blockages that create the gasping, wheezing 

and suffocation that characterize asthma. 

And with $50 million and more of investment support, 

Asthmatx has considerable breathing room on the road to 

winning approval for its Alair Bronchial Thermoplasty system. 

And because, according to the company, the Alair will 

offer the only device therapy for treatment of asthma, it can 

claim considerable competitive breathing room as well. 

Asthmatx last week reported filing of the final module 

of its PMA application for the system for treating severe 

asthma. Importantly, the FDA has granted the system expedited 

review status. 

The breathing difficulties of asthma are the result of 

blocked airflow to the lungs, the result of airways in the 

lungs squeezing shut. No cure, no method of preventing 

this, has been found. It can only be reversed for awhile with 

a combination of pharmaceuticals, including inhalers for 

long-term and short-term relief. 

But these drugs frequently lose their effectiveness, 

with Asthmatx initially targeting those lacking control with 

the use of drugs. 

An estimated 20 million in the U.S. have asthma, and 

the company is targeting the 15% of adult suffers whose 

asthma is poorly controlled by drugs, or about 2 million. 

Asthma kills an estimated 4,000 annually, with reports of 

people found dead, clutching their inhalers. At least one of 

the most popular inhaled drugs, Advair, has been associated 

with an increased risk of death. 

As an alternative to drug therapy, the company’s device 

strategy is built on the concept that if you reduce the ability 

of the airways to constrict, you maintain better air flow 

and increase the number of symptom-free days for the 

asthma patient. 

And the apparent strength of Asthamtx’s early 

research has resulted in a $50 million investment from 

Olympus (Tokyo), plus subsequent equity investments. 

Gren France, CEO of Asthmatx, told Medical Device 

Daily that the company has been in a sort of semi-stealth 

mode, not withholding information about itself but also not 

pushing for publicity because investors are coming to it. 

France declined to reveal the total cash raised by the 

company but said that its funding could be put “between 

$50 million and $100 million,” likely to carry it through to 

product commercialization, assuming approval. 

The Alair system works by delivering thermal energy to 


the smooth muscles of the airways and limiting their ability 

to constrict. 

“Our concept was, if we would be able to reduce airways 

restriction in these . . . high-flow, high-velocity airways 

[of the lungs] it would increase flow through the system.” 

In operation, a catheter probe is delivered down the 

mouth or nose to these airways in a standard endoscopy 

approach – the patient given light anesthesia – and a series 

of rib-like structures at the tip of the probe are expanded 

against the airway walls, with the thermal energy delivered 

against them. 

Called bronchial thermoplasty, the procedure is delivered 

in three separate treatments – to the right lower lobe, 

then to the left and then to both upper lobes of the lung - 

and the patient able to leave the office and resume normal 

activities after each treatment. 

The first module of company’s PMA application was 

filed last July, and the third and final module was submitted 

on Dec. 30. The PMA submission is based on one-year data 

on 297 patients from the company’s Asthma Intervention 

Research 2 (AIR2) pivotal trial. 

France told MDD that Asthmatx will release data details 

from the AIR2 trial at the May annual meeting of the 

American Thoracic Society (New York) in San Diego and 

that it is preparing a manuscript for publication. 

Characterizing the AIR2 results, he said that the device 

has demonstrated the ability to provide up to 90 days of 

asthma-free symptoms, beyond the patient’s ordinary 

experience, to those with asthma that is poorly controlled 

by drugs. 

In the trial, patients in the control group went through 

a sham treatment, with a team evaluating these patients in 

recovery unaware of which patients received the sham, 

which the actual, treatment. 

The primary effectiveness endpoint was the change 

from baseline in Asthma Quality of Life Questionnaire 

score. Safety was assessed by comparing the short and 

long-term experience for both groups. 

In earlier research concerning the Alair, reported in a 

July 2008 issue of the New England Journal of Medicine, 112 

subjects were treated with either the Alair or sham. The 

treated group had a reduction in asthma symptoms, 

showed greater morning peak expiratory flow, had an 

increased number of symptom-free days and needed fewer 

puffs of their “rescue”-type inhalers. 

The company says that following bronchial thermoplasty 

there is often an increase of respiratoryrelated 

symptoms but that these “resolve on average 

within seven days with standard care.” And according 

to the data in the NEJM study, the after-procedure 

symptoms were no different between treated and control 

groups. 

French said that the FDA’s granting of expedited review 

might more quickly bring to patients what he called “a 




15 

breakthrough technology” targeting a disease need that is 

“indisputable.” 

The total clinical experience with the Alair system 

includes, to date, more than 800 bronchial thermoplasty 

bronchoscopies with long-term follow up data available. 

“We have,” French said, ‘an extraordinary amount of clinical 

experience across disease severity and follow-up out to 

five years.” 

“We are encouraged by the consistency of the data that 

we have seen across four clinical studies in patients with 

asthma,” said Gerard Cox, professor of medicine at 

McMaster University (Hamilton, Ontario), and an investigator 

in the company’s four bronchial thermoplasty studies. 

“The results of the randomized trials show a significant and 

persistent improvement in asthma control and quality of 

life in patients with severe asthma.” 

The singular status of the company’s technology perhaps 

works to some disadvantage by not having reimbursement 

codes in place, but France noted the large benefits 

of the device – reductions in doctors’ visits, emergency 

room trips (estimated at 2 million yearly) and hospitalizations 

(an estimated 500,000 yearly) and the need for fewer 

drugs. And he noted that the device addresses one of those 

chronic components of illness that soaks up 80% of the 

healthcare dollar. 

All of these advantages point to likely coverage by the 

Centers for Medicare & Medicaid Services. 

He also suggested that while the company is initially 

focused on severe disease, this could be expanded to more 

moderate illness. 

The question of to usefulness in children is more tenuous, 

France acknowledged. He called that population “a different 

animal” with a different anatomy, requiring considerably 

more modification and testing of the device. 

France said that Asthmatx is hoping for FDA approval 

and then U.S. product roll-out early in 2010 and that this will 

drive ramp-up of infrastructure for sales in Europe, where 

the system already has the CE mark. 

(This story originally appeared in the January 22, 

2009, edition of Medical Device Daily.) 



16 

AIR2 data bodes well for 

1st asthma device therapy 

By AMANDA PEDERSEN 


A device designed to help adults with the most severe 

cases of asthma – without the use of drugs – is getting closer 

to becoming available in the U.S. Results of the Asthma 

Intervention Research 2 (AIR2) trial of the Alair Bronchial 

Thermoplasty system, developed by Asthmatx 

(Sunnyvale, California), were reported today at ATS 2009, 

the international conference of the American Thoracic 

Society (New York), in San Diego. The Alair system is on 

track to becoming the first device therapy available for 

asthma patients in the U.S. 

According to Asthmatx, the AIR2 results demonstrated 

statistically significant improvements in quality of life 

measurements and reductions in asthma attacks (severe 

exacerbations) and emergency room visits for respiratory 

symptoms in adults with severe asthma who underwent 

bronchial thermoplasty delivered by the Alair system. 

“The reduction in asthma attacks and improvements in 

quality of life are consistent with the outcomes from previous 

trials,” said Mario Castro, MD, a professor of medicine 

and pediatrics at the Washington University School of 

Medicine (St. Louis), and a principal investigator in the AIR2 

trial. “These outcomes provide further clinical evidence 

needed to demonstrate the safety, effectiveness and long 

term benefits of bronchial thermoplasty.” 

The AIR2 trial was designed to evaluate the safety and 

effectiveness of bronchial thermoplasty in adult patients 

with severe asthma who were symptomatic, despite being 

treated with high doses of standard of care medications 

(high dose inhaled corticosteroids and long-acting bronchodilators). 

The study was a randomized, double-blind, 

sham-controlled trial and enrolled 297 patients at 30 sites 

in six countries. The primary effectiveness endpoint was 

the change from baseline in Asthma Quality of Life 

Questionnaire (AQLQ) score. Comparing the short and 

long-term safety profiles for both the treatment and sham 

control groups assessed safety, Asthmatx noted. 

According to the company, the key statistically significant 

clinical findings of the trial were: improvement in the 

average AQLQ score at six-, nine-, and 12 months over sham 

control; four out of five Alair-treated patients responded 

with a clinically significant improvement in AQLQ compared 

to 64% of sham controls; 32% reduction in asthma 

attacks; 84% reduction in emergency room visits for respiratory 

symptoms; 36% reduction in patients reporting 

episodes of asthma (multiple symptoms) adverse events; 

and 66% reduction in days lost from work/school or other 

activities due to respiratory symptoms. 

While investigators were expecting to reach the primary 

endpoints of the AIR2 trial, Castro told Medical Device 


Daily that he was somewhat surprised at the “pretty 

marked reduction in severe exacerbations of asthma and 

emergency room visits,” because “typically studies have to 

be quite large with asthma to meet an endpoint like that.” 

In fact, those were the results that had the most impact 

with doctors and patients because they can relate to a number 

of ER visits more so than some of the other findings, 

Asthmatx CEO Glen French told MDD. 

Bronchial thermoplasty is a non-drug procedure for 

asthma. The treatment is performed through the working 

channel of a standard flexible bronchoscope that is introduced 

through a patient’s nose or mouth, and into their 

lungs. The tip of the small diameter Alair catheter is 

expanded to contact the walls of targeted airways. 

Controlled thermal energy is then delivered to the airway 

walls to reduce the presence of airway smooth muscle that 

narrows the airways in patients with asthma. The minimally 

invasive procedure, like many other flexible endoscopy 

procedures, is done under light anesthesia, and the patient 

returns home the same day, according to Asthmatx. 

Castro told MDD that the treatment is actually delivered 

in three sessions: first in the right lower lobe of the 

lung; next in the left lower lobe; and the third in the upper 

lobes. The patient has to wait about two weeks between 

sessions to ensure that they are stable enough to go 

through the procedure, he said. 

Asthmatx said that in the period immediately following 

bronchial thermoplasty, there is an expected increase and 

worsening of respiratory-related symptoms, which are of 

the type expected following bronchoscopy in patients with 

asthma. The company said these events typically occur 

within a day of the procedure and resolve on average within 

a week with standard care. In the long term, fewer 

bronchial thermoplasty treated patients reported respiratory 

adverse events and there was a significant decrease in 

patients reporting asthma (multiple symptoms) adverse 

events in the Alair-treated group compared to the sham 

control group. 

“The results from AIR2, similar to the results from two 

prior randomized clinical trials evaluating the Alair system, 

demonstrate that patients with severe asthma can experience 

clinically significant improvements in their asthma 

control and their quality of life,” French said. 

The results of this pivotal study have enabled 

Asthmatx to submit a premarket approval application 

(PMA) to the FDA for regulatory approval, the company 

said. 

“Participation in the AIR2 trial required an extraordinary 

level of involvement from all patients, and we were 

encouraged by the very high level of interest from patients 

who wanted to participate,” Castro said. “This high level of 

patient interest and involvement in this complex and timeconsuming 

trial reflects the substantial clinical need that 

exists for new treatment options in this population of 

patients with severe asthma.” 




17 

The company has already filed the final module of its 

PMA application for the system and the FDA has granted it 

expedited review status. French said that in early April the 

agency had some questions related to the submission and 

that the company is in the process of answering those 

questions. Assuming its responses satisfy the FDA’s 

inquiries, he said the next step would be to schedule an 

advisory panel meeting. Assuming that meeting goes well, 

and if everything else goes according to plan, Asthmatx 

hopes to introduce the device to the U.S. market early next 

year, French said. He said the company believes it has a 

“tremendous amount of clinical research” backing it up and 

has been collaborating with FDA for nearly a decade, finetuning 

the studies along the way. “This study means everything 

to the company, in a sense,” French said. “It will determine 

for us if [the device is] sufficient to meet FDA’s standards, 

which we believe it is.” 

The Alair system has received a CE mark for use in 

Europe, the company noted. Also, in 2006, bronchial thermoplasty 

was ranked fifth on the Cleveland Clinic’s “Top 

Ten” list of medical innovations for 2007. That list marked 

the first of what has become an annual list from the clinic. 

“The treatment we have available for asthma currently is 

primarily based on education and pharmacotherapy . . . 

pharmacotherapy in this group of patients has really reached 

its limits in that it is still not achieving control of asthma 

symptoms,” Castro told MDD. He said pulmonologists are 

looking forward to this device because it is something new 

they will be able to offer these patients to try to improve the 

control of their asthma symptoms. He also said doctors are 

looking for a therapy that is not associated with long-term 

adverse side effects as the current asthma treatments are. 

So far, Castro said, the reaction to the Alair system from 

his colleagues in the field has been “overwhelming.” The 

last time the company presented data on the device the 

room was packed and actually spilling out into the hallways, 

he said. 

Castro emphasized the importance of this potential 

new asthma therapy by noting the seriousness of the problem 

for these types of patients. These patients are really 

disabled by their asthma, he said, and their quality of life is 

quite impaired. 

(This story originally appeared in the May 19, 2009, edition 

of Medical Device Daily). 



18 

ATS Medical wins FDA 510(k) 

for new annuloplasty band 

By AMANDA PEDERSEN, 


For companies making annuloplasty bands, it can be a 

bit tough to distinguish what they are selling from all the 

other annuloplasty bands and rings on the market. But ATS 

Medical (Minneapolis), a company that recently reported 

FDA clearance of its ATS Simulus Adjustable Annuloplasty 

Band, says surgeons will want to choose its device for its 

“simple but elegant” design. 

“The biggest problem in the ring market is that it’s saturated 

. . . there are about 20 rings to choose from and 

they’re all pretty much the same,” Robyn Peterson, marketing 

director for repair products, told Medical Device Daily. 

But in general, she said, the Simulus brand itself is what 

makes this latest annuloplasty band unique. 

According to ATS, the Simulus annuloplasty products 

were designed with the help of cardiac surgeons for 

implant ease. 

Peterson said that the braided polyester construction 

allows for easy needle passage and it is non-compressible, 

so it does not stretch or crunch. Also, she said she has 

heard from physicians who have used the band who say it 

results in faster procedure times. 

The new band is the next product in a portfolio of 

mitral valve repair products developed and commercialized 

through the company’s partnership with Genesee 

BioMedical (Denver). 

This band respects the natural motion of the mitral 

annulus and its proximity to the aortic valve allowing for a 

safe, physiologic valve repair, according to ATS. The design 

of the device allows the surgeon to make asymmetric or 

symmetric adjustments to the posterior segment of the 

mitral valve annulus at any time during the procedure, optimizing 

the repair. This product is also indicated for tricuspid 

valve repair, where a band is the preferred annuloplasty 

device, the company noted. 

Annuloplasty rings and bands are used in those cases 

where repair of a patient’s heart valve is preferable to 

replacement of the valve. The ATS Simulus Adjustable Band 

provides additional options for surgeons in terms of different 

exposures, double valve procedures and minimally 

invasive implants, according to ATS. 

John Wright, PhD, CEO of Genesee BioMedical, has been 

involved in heart valves and valve repair therapy for more 

than 25 years. According to ATS, Wright’s experience has 

contributed significantly to the “enormous growth” of the 

Simulus product line. 

“Our valve repair business continues to grow and build 

momentum,” said Michael Dale, president/CEO of ATS. “We 

have expanded our repair platform by adding offerings in 

the flexible and semi-rigid segments. The breadth of our 


portfolio will enable more choices for our surgeon customers 

to accommodate their clinical needs and that of 

their patients, thus bolstering our growth prospects.” 

ATS says it serves the cardiac surgery community by 

focusing on two distinct but operationally synergistic market 

segments: heart valve disease therapy and surgical 

ablation of cardiac arrhythmias. 

The company was originally founded to develop the 

Open Pivot heart valve as a new mechanical heart valve 

standard of care. Today the Open Pivot heart valve is the 

preferred mechanical heart valve in many markets around 

the world and the fastest-growing mechanical prosthesis in 

the market, according to the company. 

(This story originally appeared in the May 22, 2009, 

edition of Medical Device Daily). 




Avantis keeps ‘3rd eye’ open 

for detecting colon cancer 

By OMAR FORD 


Avantis Medical Systems (Sunnyvale, California) is 

getting a better view when it comes down to properly finding 

tumors during colonoscopies. And the company literally 

means that. 

The company reported this week that it has received 

510(k) clearance from the FDA for its Third Eye Restroscope, 

a chip-on catheter device. Avantis said it is in a limited market 

release of the device. 

The device literally is the “third eye” when it comes to 

performing colonoscopies, said Scott Dodson, CEO of 

Avantis. 

“One eye is the physician’s eye, another is the colonscope’s 

eye and the third and final eye is the third eye,” he 

told Medical Device Daily. 

The Third Eye Retroscope is indicated for use with 

colonoscopy to provide the physician with an additional 

view of the colon for diagnostic and detection purposes. 

Shaped like a J, the device is passed through the instrument 

channel of a standard colonoscope until it extends 

beyond its tip. As it emerges, the device automatically turns 

180 degrees to aim “backward” toward the tip of the colonoscope. 

Then, as the colonoscope is withdrawn from the 

colon, the device provides a continuous retrograde view to 

reveal polyps, cancers and other lesions that might be hidden 

from the view of a standard colonoscope. 

“It operates as a rear-view mirror for the physician,” 

Dodson told MDD. 

The device includes: 

• An integrated light source on the catheter provides 

illumination without the need for a costly additional external 

light source. 

• Retrograde view that reveals areas behind folds in 

the colon wall. 

• A foot pedal that captures still images from both the 

forward and retrograde views simultaneously. 

• A video processor and monitor integrate with standard 

colonoscopy systems and display both forward and 

retrograde views on the same monitor. 

To date the device has been used in clinical trial settings 

and is being prepped to hit the market. 

“Our national study indicated that the Third Eye 

Retroscope, when used in combination with a standard forward-viewing 

colonoscope, revealed areas that are often 

hidden from the standard colonoscope,” said Douglas Rex, 

MD, Third Eye investigator, at Indiana University School of 

Medicine and director of endoscopy at Indiana University 

Hospital (both Indianapolis). “The device also enabled 

detection of 13% more polyps and 10.9%more adenomas 

than the colonoscope alone. These results are important to 

19 

doctors and patients because most cases of colon cancer 

arise from adenomas.” 

Colorectal cancer is the second-leading cause of cancer 

death in the U.S. and Europe. Most of these cancers can be 

treated if hif they are detected early and even more cases 

can be prevented if pre-cancerous polyps are removed 

before they become malignant. However research has 

shown that 12% to 24% of polyps and a significant number 

of cancers can be missed during colonscopies. 

Even more revealing is a recent large study analysis 

involving more than 10,000 cancer patients who died of colorectal 

cancer that indicated that colonoscopy missed 

about one-third of colorectal cancers on the left side of the 

colon and 40% to 67% of the colorectal cancers on the right 

side of the colon. The company said that the study showed 

that twice the number of patients had polyps on the rightside 

of the colon vs. the left side. 

“Unlike most market development technologies, there 

isn’t a need to prove the need for the device, there is welldocumented 

evidence that shows us there is a clear need 

for the device,” Rex said. “The miss rates for a colonoscopy 

is incredible. This remains one of the most hotly contested 

topics for gastrointestinal specialists (GI).” 

One could argue the point that this was not only a serious 

matter for GIs but also for venture capitalists and 

financers. Even in a tough economy, financiers continued to 

support Avantis and its vision and the company was able to 

close on $10 million in Series C founding to facilitate the 

launch of the Third Eye (Medical Device Daily, Jan. 21, 2009). 

The company raised $12 million in its Series B round of 

financing in October 2006. 

(This story originally appeared in the Feb. 19, 2009, edition 




20 

FDA approves first stem cell 

gene therapy study for CHF 



How can you mend a broken heart Grow new heart tissue. 

Bioheart (Sunrise, Florida) is launching the very first 

clinical trial ever to test a combination gene and stem cell 

therapy for congestive heart failure (CHF), a condition for 

which there is no cure other than a transplant. Bioheart has 

reported that the FDA cleared a phase I trial for MyoCell 

SDF-1 (Stromal Derived Factor-1) to treat CHF. 

“In our animal studies, we saw double the improvement 

that we did in the first-generation MyoCell products,” 

Kristin Comella, VP of R&D and corporate development, told 

Medical Device Daily. The 15-patient REGEN trial will be a 

multicenter, randomized, dose escalation study to assess 

the safety and cardiovascular effects of the implantation of 

MyoCell SDF-1 in CHF patients post myocardial infarction. 

Those patients will then be followed for 12 months. 

MyoCell SDF-1 is a composition of myogenic stem cells 

derived from a patient’s own thigh muscle that has been 

modified to over-express the SDF-1 protein. Using a needletipped 

catheter inserted into the groin of a patient who is 

suffering from CHF, the cells are injected into the scar tissue 

that has formed in the patient’s heart. 

“It’s almost certain that you develop scar tissue with 

CHF because if there is no longer blood flow to the heart 

and no oxygen, the damaged muscle leads to scar tissue,” 

Comella said. In addition to growing new heart tissue, 

Comella said investigators hope that the therapy will also 

lead to reverse remodeling (shrinkage of the heart) because 

most people with CHF generally developed enlarged hearts 

as a result of CHF. They would also like to improve quality 

of life and extend life, but none of these issues are endpoints 

of this phase I trial. 

The goal of MyoCell SDF-1 is to grow new contractile 

muscle within the scar tissue that will have the ability to 

release additional beneficial proteins to assist in the tissue 

repair process and improve the patient’s heart function, 

exercise capacity and quality of life. Comella said, “With this 

second-generation product, we transduce the cells using a 

viral vector to over-express SDF 1, which is the protein that 

assists in the angiogenesis process to form new vessels. It 

also acts as a homing signal to attract more stem cells to 

the area.” 

Last year the company reported that the first-generation 

product, MyoCell myoblast clinical cell therapy, is a 

safe and potentially effective alternative treatment to standard 

medical therapy alone for improving heart function 

among patients with previously implanted cardiac devices 

who are experiencing CHF. The findings from the SEISMIC 

trial, a 40-patient, randomized, multicenter, controlled, 


phase II-a study conducted in Europe, evaluated MyoCell 

myoblast clinical cell therapy delivered via the MyoCath, 

endoventricular needle-injection catheter in patients previously 

fitted with implanted cardiac defibrillators, receiving 

standard medical therapy and who are experiencing congestive 

heart failure. 

Preclinical studies of this second-generation product, 

MyoCell SDF-1, showed that it provided a 54% improvement 

of heart function compared to 27% for the original MyoCell 

composition while the placebo control treated animals 

declined by 10%. The preclinical studies also demonstrated 

that MyoCell SDF-1 can enhance blood vessel formation in 

damaged hearts. 

“We are happy to be able to begin the REGEN trial to test 

this promising product candidate in heart failure patients 

after completing very successful preclinical testing,” said 

Howard Leonhardt, Bioheart’s chairman/CEO. “To our 

knowledge, this will be the first clinical trial ever to test a 

combination gene and stem cell therapy for cardiovascular 

disease.” 

The U.S. trial is expected to begin this year. After completing 

the REGEN safety protocol with one-month followup, 

the company plans to transition the second-generation 

product into its FDA-authorized phase II/III MARVEL study. 

MyoCell SDF-1 is substantially similar to the original 

MyoCell composition that has been active in clinical trials 

since early 2001 at more than 50 centers worldwide. The 

patents Bioheart has acquired covering the myogenic cells 

and SDF-1 compositions and methods are expected to provide 

intellectual property protection until 2023. 

Bioheart is working to keep the funding pipeline open 

to continue the studies, despite some difficulties. Last year, 

Bioheart made headlines as the only biotech firm to raise 

money through an initial public offering on the U.S. markets, 

though it raised only $5.8 million through the sale of 

1.1 million shares at $5.25 each (MDD, Feb. 22, 2008). But in 

March, the company received notification from Nasdaq that 

its listing was discontinued after it failed to comply with 

certain requirements, including the market value of its 

common stock and either minimum stockholders’ equity or 

net income from continuing operations of $500,000 in the 

most recently completed fiscal year or two of its last three 

most recently completed fiscal years. 

Bioheart is in the midst of a fundraising. Earlier this 

month, it reported that commencing on Oct. 1, 2008, and 

through July 7, 2009, Bioheart received proceeds in the 

amount of $2.85 million from the placement of restricted 

common stock and warrants under its current offering 

under Regulation D. That term has been extended through 

October 2009. 

(This story originally appeared in the July 29, 2009, edition 





BodyViz gives 3-D look to MRI, 

speeds up pre-surgery planning 

By OMAR FORD 


When Tom Lobe MD, went on a tour with his daughter 

to Iowa State University (Iowa City) to find an engineering 

program suitable for her, the last thing he expected to do 

was come upon a novel imaging program that would redefine 

the way physicians and surgeons look at an MRI. 

Lobe went to the school’s Virtual Reality Applications 

Center, which had a 3-D visualization of the universe. The 

visuals were so intense and so engrossing, that Lobe put on 

his thinking hat and asked if this could be done with the 

human body. 

“We were at Iowa State University and she was interested 

in Engineering, so I asked if we could see their state of 

the art Virtual Reality Applications Center,” Lobe said. I was 

amazed how advanced 3-D visualization had become and 

immediately thought a view of the human body like this 

could open up a whole new world for surgeons.” 

And from there, Lobe, along with Iowa State University 

academicians, formed an alliance that led to the creation of 

BodyViz (Ames, Iowa) and its product of the same name. 

“BodyViz runs on laptops and work stations,” Curt 

Carlson, BodyViz CEO told Medical Device Daily. “The cost 

combined with how simple it is to use, download and install 

will ultimately change the way surgeons prep for surgery, 

educate patients and help oncologists treat tumors with 

greater accuracy.” 

Once the physician gets the MRI, he or she then runs it 

through the BodyViz program, which can give a 3-D model 

of the scan. 

Doctors can shift, adjust, turn, zoom and replay a three 

dimensional rendering of an MRI of a patient. The company 

uses an X-Box controller to move to different parts of the 

scan. Physicians can then use the information to plan a surgery 

or a round of radiation therapy. 

BodyViz said its imaging application cuts pre-surgery 

planning time from an hour to about four minutes. 

Lobe, a surgeon at Blank Children’s Hospital in Des 

Moines and BodyViz creator, said he knows how critical it is 

to save time in the operating room. 

Lobe says, “In the past, I had to plan, draw pictures, 

imagine and finally guess at the best approach before I 

could begin surgery. This takes time while the patient is 

under anesthesia and lying on the operating table. BodyViz 

allows a surgeon to take CT or MRI images and do all these 

tasks himself, simply and quickly, so no time is lost and 

there are no surprises on the day of surgery.” 

Two-dimensional imaging technologies have been the 

norm in medicine for a long time, but those flat images 

leave much to be desired and are only understood by specialists. 

“What our surgeons are doing now is working in 2-D,” 

Carlson told MDD. He summed up the change saying that 

the device goes from “2-D in guessing, to 3-D in knowing.” 

The slogan is catching on and the response for the 

imaging application has spurred a great deal of interest 

from surgeons, academic institutions and even high 

schools. 

“There are a lot of different uses for BodyViz, Carlson 

said. “It’s great for patient education. With this, they get the 

chance to take part in preoperative planning. In addition 

we’re finding higher education facilities and high schools 

purchasing the BodyViz as a teaching tool.” 

Such great response has led to the company being primarily 

funded through revenue generated from its core 

product, which received FDA approval in March. 

There are plans, however, for the company to seek a 

round of financing 

“We’re probably going to go out for a round financing in 

the next six months,” Carlson said. 

The company was launched with a grant of $109,533 

from the Grow Iowa Values Fund, a state economic development 

program back in 2007. 

In addition, the company won the $25,000 top prize in 

the 4th annual John Pappajohn Iowa Business Plan 

Competition. 

And earlier this year, BodyViz was named Outstanding 

Startup Company of the Year as part of the Technology 

Association of Iowa’s Prometheus Awards. 

(This story originally appeared in the Nov. 17, 2009, edition 


21 



22 

Staple-sized neurostimulator 

could reduce stroke damage 

By OMAR FORD 


Each year 750,000 Americans suffer from stroke. It’s 

the third leading cause of death in the U.S. and the leading 

cause of long-term disability. 

But a staple-sized neurostimulator could prove itself to 

be a huge breakthrough in the treatment of ischemic 

stroke. Or at least that’s what Brainsgate (Caesara, Israel) 

and researchers involved in a clinical trial evaluating the 

device are hoping. 

The miniature neurostimulator is a doughnut-shaped 

transmitter that’s placed in the patient’s mouth near the 

sphenopalatine ganglion, a nerve located in the roof of the 

mouth. A steady stream of electrical stimulation is then 

delivered for several hours a day throughout a five dayperiod. 

The effect of stimulating the sphenopalatine ganglion 

leads to the arteries dilating so that more blood flow 

is delivered to the stroke-affected hemisphere of the brain. 

The tiny device, which is vying for FDA approval, is 

then removed from the patient’s mouth. 

What the company and researchers are trying to prove 

in the Impact-24 clinical trial, is that the device can treat 

patients without serious side effects. 

“If this treatment is successful, it would be a major 

advancement in stroke treatment,” David Chiu, MD, medical 

director of the Eddy Scurlock Stroke Center and the study’s 

primary investigator at Methodist Neurological Institute 

(Houston) told Medical Device Daily. “It could also substantially 

increase the number of stroke patients we’ll be able to 

treat.” 

The device will hopefully allow for an enhanced window 

of time for the effective treatment of stroke. Currently, 

that window is up to four hours with the use of an FDA 

approved drug known as tPA. 

“TPA is a clot busting drug, if you go beyond the recommended 

four hours, it doesn’t work,” he said. “Plus using 

the drug is a double edged sword because there’s always 

the risk of brain hemoharrage that accompanies using it for 

treatment.” 

Brainsgate’s device is much more suitable, according to 

Chiu, because it has been shown to have very minimal side 

effects. 

“Patients sometimes feel a bit of a tingle on the side of 

their face or in their mouth, but nothing serious,” he added. 

The trial is a multicenter, randomized, double blind 

study taking place worldwide over the next two years. 

Methodist said it was one of six locations in the country to 

offer this study. To date about four patients have been 

implanted with the device at Methodist. 

If the study has positive results then the FDA could possibly 

broaden the trial to include more patients in the U.S. 


“We’re always involved in trying to push the envelope 

of what we can do to help our stroke patients,” Chiu said. 

Brainsgate has recently seen a great deal of significant 

activity. In August the company, which bills itself as a developer 

of a therapeutic platform technology based on electrical 

neurostimulation, reported the completion of a $27.5 

million Series C financing round in which both new and 

existing investors participated (Medical Device Daily, 

August 14, 2008). 

Johnson & Johnson Development led the round, joined 

by VC-Fund Agate Medical Investments, headed by former 

Israeli Minister of Health Danny Naveh. Existing investors 

who also participated in the current round included Elron 

Electronic Industries (Tel Aviv), Pitango Venture Capital, MB 

Venture Capital and Alice Lab. 

If Brainsgate continues its success and gets its device 

approved by the FDA it could enter into a growing treatment 

and prevention market. 

Invatec (Roncadelle, Italy) has developed a cerebral 

protection device that can be used during CAS procedures 

to prevent debris from reaching the brain. The company 

received FDA 510(k) clearance for its Mo.Ma Ultra Proximal 

cerebral protection device for use during CAS (MDD, Oct. 

26, 2009). According to the company, the device reduces 

and captures debris released during the stenting. The company 

also said it has completed the ARMOUR trial, which 

demonstrated low stroke and major adverse cardiac and 

cerebrovascular event rates. 

W. L. Gore & Associates (Flagstaff, Arizona) makes a 

device that was approved earlier this year by the FDA. The 

Gore Flow Reversal System is designed to reverse the flow 

of blood during stenting procedures. According to Gore, its 

neuroprotection technology reverses the flow of blood at 

the treatment site prior to crossing the lesion so there’s 

almost no chance that particles could escape to the brain. 






Cameron in CE mark testing of 

subcutaneous, ICD leadless tech 

By OMAR FORD 


To say that there are issues concerning the safety of 

implantable cardioverter defibrillator devices would be an 

understatement. 

A massive recall of the Sprint Fidelis lead made by 

Medtronic (Minneapolis) helped solidify a variety of questions 

related to their use in the company’s ICDs, after five 

people implanted with the Fidelis ICD leads died because of 

fracturing, a problem found to be much more frequent than 

the expected risk parameters. The leads were eventually 

pulled from the market, with class action lawsuits lined up 

against the company as a consequence. 

And more recently, two cardiologists, Dr. Robert Hauser 

and Dr. Adrian Almquest, in the New England Journal of 

Medicine, have raised questions concerning the bench-testing 

proposed for a new type of significantly thinner defibrillator 

lead, which would require four lead placements in 

the heart, being developed by major cardio firms. 

And, in any case, whatever type of ICD lead is used, the 

requirement is for insertion in or near the heart. 

As an advanced technical response to these issues, two 

electrophysiologists, Gust Bardy, MD, and Riccardo 

Cappato, MD, have founded Cameron Health (San 

Clemente, California) to develop a device that they offer as 

providing all of the strengths of the ICD lead but none of its 

weaknesses. 

After nearly nine years of development, the company 

this week reported that it has begun trials of its 

Subcutaneous Implantable Defibrillator (S-ICD) System, as 

support for winning CE mark approval, a system that provides 

ICD shock but without the need of leads inserted in or 

near the heart. 

The company said that 14 patients have received an S- 

ICD System as part of the CE trial, which will enroll up to 55 

patients at 10 centers in Europe and New Zealand. 

Richard Sanders, VP of sales and marketing for 

Cameron, told Medical Device Daily that the device was 

designed by Bardy and Cappato, “who thought that there 

must be a better way for ICD procedures.” 

He added that the therapy “is very effective,” while also 

acknowledging “potholes” in the process of development. 

“The original concept was to completely alleviate the 

need for any lead or electrode and incorporated a shoehorn-shaped 

can which can be slipped under the skin and 

over the ribs. The first generation of device, while not leadless, 

accomplishes the same thing.” 

Components of the Cameron Health S-ICD System 

include the SQ-RX Pulse Generator, Q-TRAK Subcutaneous 

Electrode, Q-GUIDE Electrode Insertion Tool and the Q-TECH 

Programmer. 

23 

The S-ICD System is implanted subcutaneously (just 

under the skin), with the electrode running parallel and 

slightly to the left of the sternum. While most functions are 

automatic, adjustments and data retrieval can be easily 

achieved through what the company says is an advanced 

integrated programming system developed specifically for 

the S-ICD System. 

The company says that the Q-TECH programmer is one 

of the smallest units in the industry, weighing less than 

three pounds. And the light-weight, portable unit is capable 

of wireless communication with the SQ-RX Pulse Generator. 

To implant Cameron’s device, physicians and surgeons 

need only surface anatomical landmarks, such as the 

breastbone, without any imaging equipment. 

Commenting on the clinical trial and the first CE trial 

patient to receive the S-ICD System in New Zealand, 

Margaret Hood, MD, in a release said, “Our initial experience 

with this new technology has brought positive results. The 

whole procedure was surgically simple. Once implanted, 

the S-ICD System can be programmed to automatically 

optimize the device parameters for monitoring the heart’s 

rhythm while removing some of the complexity inherent in 

conventional systems. Traditional ICDs are a bit more complicated 

in their implantation and a bit more costly. 

Conventional ICDs require placement of at least one 

lead in or on the heart. Most frequently, these leads, constructed 

of thin insulated wires, are threaded through a 

vein and then placed inside the heart. These conventional 

transvenous leads allow for sensing of the heart’s rhythm 

and delivery of a life saving electric shock when a harmful 

arrhythmia is detected. 

But the surgical placement and residence of these 

transvenous leads within the patient’s heart are associated 

with a significant proportion of the complications related 

to this well-established and highly effective therapy. 

Those reports include patients receiving constant unnecessary 

shocks and, in some cases – as with the case of the 

Fidelis lead – death. 

“So far feedback for (S-ICD) System has been extremely 

favorable,” Sanders said. 

The company said that that its expectation is to apply 

for an investigation device exemption by the first quarter 

of this year. 





24 

Nanoporation aims chemotherapy 

at cancer targeted by devices 



One of nanotechnology’s greatest selling points in the 

medical arena is the ability to target and destroy cancerous 

tissue without the negative side effects of systemically 

delivered therapies. But a big stumbling block is exactly 

how to concentrate those nano-sized therapies at the disease 

site. An international collaboration of companies 

along with researchers at University of Dundee (UD; 

Scotland) are tackling that dilemma. 

“We are taking a more mechanistic approach, using 

medical devices and not involving chemical targeting. The 

nanoshells we use don’t need to know where the cancer is,” 

Andreas Melzer, director of the Institute for Medical Science 

and Technology (IMSaT) at UD, told Medical Device Daily. 

UD is collaborating with InSightec (Tirat Carmel, Israel) 

and CapsuTech (Nazareth, Israel) on what’s called the 

Nanoporation Project, intended to integrate MRI, focused 

ultrasound and photonics, for the delivery and activation of 

nanocapsules that carry high doses of chemotherapy to 

effectively destroy tumors. 

The treatment starts with chemotherapy being encapsulated 

inside nanocapsules which are injected into a 

patient and remain harmless to the body until they are activated 

by a concentrated focused ultrasound blast. 

“We use a system that’s been developed by InsSightec 

for high intensity focused ultrasound (HIFU), which can be 

focused inside the body,” Melzer said. “Under controlled 

MRI, the focus spot can be placed on images taken from a 

patient showing a tumor. The benefits of using this are that 

MRI has a superior imaging of tumors and MRI has become 

good at temperature mapping. Each hot spot caused by 

HIFUs achieves 56 degrees Celsius and all the cancerous 

cells are destroyed. 

“Our approach – called MRI-guided Focused Ultrasound 

(MRgFUS) – to use the system is to actuate nano-sized 

nanocapsules which carry potent and toxic chemotherapy 

agents released from the nanoshells under the influence of 

ultrasound,” Melzer said, adding. “We avoid the side effects 

of chemotherapy this way.” 

One of the biggest advantages of nanoporation is that 

it would not only treat the obvious tumor, but also the tiniest 

cancer cells in the area that aren’t yet visible. 

Because of this particular benefit of the therapy, the 

team has chosen to develop nanoporation with immediate 


indications for colon, prostate and breast cancers. 

“Breast cancer is one of the most interesting, because 

in breast, micro-metastasized cells can’t be visualized,” he 

said. “This whole area around the tumor would be subject 

to treatment so that the breast can be preserved. Our 

approach seems to have the best application with breast 

cancer. Prostate cancer is a complex cancer with various 

treatment problems. In thermo ablation therapy or surgery 

important nerves are destroyed. Our targeted approach 

may be very appropriate for this too.” 

This would be ideal for colon cancer, too, because 

when it metastasizes, it typically grows to the liver, which 

cannot be ablated. Nanoporation would help to stem this 

spread of the micro-metastasized cells. 

InSightec’s MRgFUS system will be combined with 

CapsuTech’s nanocapsules. 

“Our approach is to take these drugs, cover then with 

nanoshells – that’s the CapsuTech part – so that the drugs are 

inert and don’t cause side effects,” Melzer said. “They work 

only when the ultrasound targets them and they are then 

released. We’ll take previously FDA-approved drugs and combine 

with a drug carrier and then it’s a medical device used as 

a drug delivery system similar to drug eluting stents.” 

Melzer’s group has been working on the project 

already for four years in cell cultures with human cell lines 

from colon, prostate and breast cancer. 

The four-year project will involve first proving that the 

drug release from nanoshells can occur on command. 

Melzer expects that to achieve this stage within the next 1.5 

years. After that, they’ll start experiments in small animals. 

One of the key points is to discover just how hot the 

focused ultrasound needs to be to release the drugs, but to 

avoid destruction of cells and the drug. 

Sandy Cochran, deputy director/team leader (Medical 

Ultrasound), IMSaT, said the drug release will likely occur at 

lower temperatures than currently used in HIFU technologies 

so that the drug isn’t destroyed along with avoiding 

burns or tissue damage around the site. 

The group will also tap into photonics technologies, 

manipulating light, as part of their research. 

“Optical elements of light are used to trap nanoparticles,” 

Cochran said. “We can localize a single nanoshell and 

load the drug under microscopes to study with high speed 

camera how the effects of ultrasound work. So photonics 

will be engaged for research use only, to study and understand 

the process.” 

Even though the chemotherapeutics, like cisplatin, will 

be delivered in such a targeted manner, it remains to be 

seen what, if any, side effects patients will experience after 




25 

the job is done and until the drugs and remaining nanocapsules 

clear the body. 

“That’s a very difficult question,” Melzer said. “We’re 

still studying how nano-sized drugs are eliminated. 

Obviously we wouldn’t go over the conventional dosages 

of the drug. But these are the same questions that surrounded 

the development of drug eluting stents. Is the 

concentration around the stent higher than if used systemically 

We intend to prove it’s the same concentration.” 

The project has been funded for four years through the 

European Union’s Framework 7 program with a €2 million 

grant. The two companies involved are contributing technology 

and resources, but have not made direct financial 

investments. 

(This story originally appeared in the Aug. 3, 2009 edition 

of Medical Device Daily.) 



26 

TCT 2009 

Carillon, MitraClip data wow 

standing-room crowd at TCT 

By MARK McCARTY 

Medical Device Daily Washington Editor 

SAN FRANCISCO – Mitral valve regurgitation has long 

proven a tough nut to crack, but recent data from trials for 

developmental devices suggests that medical science is 

making headway on this front. Some of the trials also suggest 

that the effect of these fixes on congestive heart failure 

is discernible, leading one of the presenters to remark 

that the Centers for Medicare & Medicaid Services might be 

happy to hear about some of these data. 

All the same, the FDA hurdle must be cleared first and 

the devices in question have not yet made that leap, 

although the presenters seemed optimistic on that count. 

Tomasz Siminiak, MD, of the Poznan University of 

Medical Sciences (Poznan, Poland), discussed six-month 

data from the Titan trial for the Carillon mitral valve contour 

system, made by Cardiac Dimensions (Kirkland, 

Washington). This device is fixed around the mitral valve 

and uses tension to keep it in place while the tension forces 

the mitral valve into a tighter circumferential geometry, 

hence reducing regurgitation. Unlike most percutaneous 

devices, the device is intended for delivery via the jugular 

vein. 

Reviewing six-month data from the Titan trial, Siminiak 

reminded the audience, which was a standing-room-only 

crowd, that the intended indication is for patients with 

severe regurgitation and a left ventricular ejection fraction 

of less than 30%. Inclusion criteria were New York Heart 

Association class II, III and IV heart failure and the primary 

safety endpoint was the 30-day rate of major adverse 

events (MAE). 

The device consists of two nitinol anchors and a bridge 

implanted into the coronary sinus. The distal anchor is set 

while the catheter withdraws so as to set the proximal 

anchor. The procedure can be reversed and captured by the 

catheter up to the point of decoupling of the catheter from 

the proximal anchor, so a surgeon who sees a problem with 

anchoring can reverse and withdraw. 

Siminiak noted that the Titan study enrolled 65, with 12 

who flunked screening, leaving an intent-to-treat group of 

53. Of this group, 36 were implanted while the other 17 


were not due to “insufficient mitral regurgitation reduction,” 

Siminiak said, and/or coronary artery compromise. Of 

the 53 ITT enrollees, 50 were in New York Heart Association 

class III heart failure, two were in class IV, and one in class 

II. 

Siminiak said procedural safety in Titan was excellent. 

“The major adverse event rate of 1.9% at 30 days highlights 

the safety of this procedure,” he said. Measures of regurgitation 

after six months showed that the narrowest point of 

the ejection stream had shrunk by roughly a third. “The volume 

of the jet was very small, very thin,” said Siminiak, and 

hence improvement in regurgitation was by at least one 

class in all cases. He also said the “significant reduction in 

MR was maintained after six months” and that the data indicate 

a “positive effect on remodeling.” 

The audience seemed impressed, with one attendee 

characterizing the data as “very promising.” As for whether 

any patients experienced recurrence of regurgitation, 

Siminiak said there was “a single patient with loss of detention” 

of the valve, but added that “some patients improved 

into reverse remodeling” of their heart failure. 

Siminiak remarked that the device was not exactly as 

originally designed. The Carillon was originally designed 

with two anchors made of a pair of wires each for tension, 

but there was originally no twist in the anchoring wires. 

After several early cases indicated the initial design lacked 

sufficient tension in the distal anchor, the company twisted 

those anchor wires, and the proximal anchors wires had 

also been twisted by the time the sponsor started enrolling 

for the Titan trial. 

Saibal Kar, MD, of Cedars Sinai Medical Center (Los 

Angeles), reviewed the Everest (Endovascular Valve Edgeto-Edge 

REpair STudy) trial for the MitraClip, which is 

indeed a clip that is placed about midway across the two 

leaves of the mitral valve, pinching that portion of the 

leaves together. Hence, the mitral valve is left with two 

smaller openings, and the device’s placement is intra-operatively 

adjusted for ideal ejection volume. The product is 

made by Evalve (Menlo Park, California). 

Kar observed that while “the effect of valve repair without 

annuloplasty” is not known, he remarked that the 

hypothesis is that “putting in a MitraClip might actually 

regress” congestive heart failure. Of the 78 subjects initially 

enrolled, 32 exhibited diastolic MR and the remainder 

functional MR. He noted that the estimated STS (Society of 

Thoracic Surgeons) score averaged 17%. “Most would agree 




27 

this is a really sick population,” he observed. 

Kar said that the session marked the debut of data 

for annular dimensions. “For the first time we noticed 

what happens to the septal-lateral dimensions,” he said, 

noting that for the 26 patients with one-year data, diastolic 

annular dimension dropped from 3.8mm to 3.6 and 

systolic dimension fell from 3.2mm to 3.0. As for ejection 

fraction (EF), he said there was “expected to be no 

change in EF, but impressively an improvement,” from 

48% to 42%. 

Kar also noted that the rate of rehospitalization for 

symptoms of heart failure among the 26 patients followed 

to a year was 30%. He quipped, “I’m sure Medicare would 

like to see this data.” Perhaps as impressive was the average 

regurgitation score, which dropped from 3.1 to 1.6 over 

12 months. 

According to a Sept. 22 company statement, the 

Everest echo imaging data indicate “complete fibrous 

encapsulation of the MitraClip device with organized, 

endocardial tissue growth.” The statement also indicates 

that the device is well tolerated, with “no significant stenosis 

or inflammation . . . observed beyond 300 days.” 





28 

CVT receives $750,000 seed 

funding for PMVR platform 



CardiAQ Valve Technologies (CVT; Winchester, 

Massachusetts) – a company that hopes to do for percutaneous 

mitral valve replacement (PMVR) what companies 

like CoreValve (Irvine, California) have done for percutaneous 

aortic valve replacement (PAVR) – has received 

$750,000 in seed money from Broadview Ventures, a spinoff 

of Fondation Leducq (Paris). 

“This sector is filled with significant opportunity,” said 

Brent Ratz, president/CEO of CVT. “CoreValve and others 

have demonstrated already how catheter-based heart valve 

replacement technology can address aortic stenosis. We 

believe that our platform has the unique capability to do 

the same thing for mitral regurgitation, and we are pleased 

to have Broadview’s support as we continue to move this 

exciting technology forward.” 

CVT said the funding, which brings its total funding to 

$1.5 million, will be used to further develop the company’s 

platform with an initial indication for PMVR. While the company 

is focusing on PMVR first, Ratz told Medical Device 

Daily that CVT does plan to eventually go beyond the mitral 

side to treat other parts of the heart, including the aortic 

side. 

A lot of hype has been made lately about PAVR – most 

likely due to Medtronic’s (Minneapolis) recent $700 million 

purchase of CoreValve, completed in April. And just last 

week Sadra Medical (Campbell, California), another young 

company, reported raising $30 million to further develop 

its Lotus device for PAVR. 

Edwards Lifesciences (Irvine, California) currently controls 

the lion’s share of the PAVR market but Medtronic and 

St. Jude Medical (St. Paul, Minnesota) are posturing to capture 

some of the market share as well. Edwards’ Sapien 

transcatheter heart valve received the CE mark in 2007. 

That year the company also initiated its PARTNER trial in the 

U.S. to evaluate the Sapien valve in patients who are considered 

high risk or inoperable for conventional open-heart 

surgery. CoreValve received the CE mark for its ReValving 

PAVR system in May 2007. 

But there hasn’t been as much chatter about PMVR – 

until now. 

According to CVT, when the mitral valve fails to close 

completely, blood flows back into the left atrium. The heart 

must then work harder to pump blood to the rest of the 

body, which weakens the heart and may eventually lead to 

heart failure. CVT’s solution, PMVR, is to insert a catheter 

carrying the replacement valve threaded through the 

femoral vein up into the right atrium of the heart. It is 

passed through the intra-atrial septum, into the left atrium, 

and down through the mitral annulus. The valve is partially 


expanded to engage the ventricular side of the annulus and 

establish the proper position. While the valve is now functional, 

it can be recaptured and adjusted prior to final 

deployment, if necessary. With the valve in position, the 

sheath is retracted fully. Foreshortening of the frame creates 

a clamping action that anchors the valve above and 

below the native valve annulus. 

“The real difference in the technology compared to 

anything else out there on the replacement side is that we 

don’t rely on radial force” for fixation in heavily calcified 

leaflets, which is not suitable for the mitral valve position, 

Ratz said. 

With CVT’s technology, the new mitral valve actually 

clamps on above and below the native valve annulus by 

way of a clamping motion created by foreshortening of the 

frame, Ratz explained. He said there is some level of radial 

force involved to help prevent leaking, but the technology 

does not rely on that as the sole means of attachment. 

CVT noted that several companies are attempting to 

develop percutaneous approaches to repair the mitral 

valve, but these technologies have limited applicability due 

to the heterogeneous nature of the disease and, so far, have 

had difficulty demonstrating efficacy equivalent to surgical 

approaches. 

Ratz said that there is a large unmet clinical need for 

people suffering from mitral regurgitation (MR) because 

about 19 out of 20 patients diagnosed with MR go untreated, 

primarily because their disease has already progressed 

to a point that it would be far too risky to think about 

undergoing an open surgical procedure. “There are so 

many patients that need a faster, safer, less invasive technology,” 

he told MDD. 

“No other heart valve company has a frame that is selfpositioning, 

self-anchoring, and self-conforming in three 

dimensions. Consequently, CVT’s technology has the 

unique potential to treat aortic stenosis, aortic regurgitation, 

and mitral regurgitation,” said Joseph Bavaria, MD, vice 

chief of cardiothoracic surgery at the Hospital of the 

University of Pennsylvania and professor of surgery at the 

University of Pennsylvania (Philadelphia). 

As a member of St. Jude’s structural heart advisory board 

and a principal investigator for Edwards’ PARTNER trial, 

Bavaria is well-versed in the new technologies being pursued 

within the heart valve space, according to CVT. “In vivo feasibility 

studies strongly suggest that CVT’s PMVR approach 

may provide effective treatment of MR,” said Bavaria, who is 

also chairman of CVT’s scientific advisory board. 

Ratz said CVT has received “great feedback” about its 

technology, including from the clinical side. He said that is 

particularly reassuring considering those folks see just 

about every transcatheter heart valve repair or replacement 

device come across their desk and they “still identify 

this as a novel technology.” 

While it’s still early in the development process, Ratz 

told MDD that CVT hopes to be in a first in man trial by early 




29 

2011, which puts the company in position for a CE mark by 

2013, and hopefully on the U.S. market by sometime in 2015. 

“It will no doubt be a long project and a capital intensive 

project, but we feel good about the fact that others are in 

this space on aortic side.” 

He added that hopefully by the time CVT applies for 

FDA approval, those companies with PAVR technologies 

would have already addressed some of the regulatory hurdles 

for valve replacement procedures. The $750,000 seed 

funding is an important step toward accomplishing those 

development goals. 

“The move from basic science to clinical evaluation is 

especially difficult and expensive,” said David Tancredi, 

MD, PhD, scientific director of Fondation Leducq. “Because 

funding at the early stage of a med-tech company’s evolution 

is particularly difficult to obtain, promising new technology 

may simply be abandoned. In CVT’s case, our goal is 

to prevent that from happening.” 





30 


Cardinal Health completes spinoff 

of CareFusion as separate business 


Cardinal Health (Dublin, Ohio) reported that it has 

completed the previously disclosed spinoff of CareFusion 

(San Diego) through a pro rata distribution of about 81% of 

the shares of CareFusion common stock, launching it as an 

independent, publicly traded company. 

“Our experienced management team and more than 

15,000 employees begin today ready to serve our global 

customers as a new public company,” said David 

Schlotterbeck, chairman/CEO of CareFusion. “We have a 

track record of innovation and growth that we intend to 

make a hallmark of CareFusion for the future.” 

CareFusion opens regular-way trading this morning on 

the New York Stock Exchange and will be included in the 

S&P 500 index. The new medical technology company is a 

provider of products and services that help healthcare 

institutions worldwide measurably improve patient care. 

Among other items, the CareFusion board named 

Schlotterbeck as chairman in addition to his existing CEO 

role, and Michael Losh as presiding director. 

After the close of business on Monday, Cardinal Health 

distributed to its shareholders 0.5 shares of CareFusion 

common stock for each outstanding Cardinal Health common 

share held as of market close on Aug. 25. In addition, 

Cardinal Health retained about 41 million shares, which pursuant 

to the IRS private letter ruling for the spinoff, it is 

required to divest within five years. Including shares held 

by Cardinal Health, there are about 222 million shares of 

CareFusion common stock outstanding following the spinoff. 

CareFusion products and services include Pyxis automated 

dispensing systems, Alaris IV pumps, ChloraPrep for 

the reduction of surgical-site and catheter-related infections 

and V. Mueller surgical instruments. 

With $3.7 billion in revenue for fiscal year 2009 that 

ended on June 30, CareFusion is one of the world’s largest 

medical products makers. The company projects mid-single-digit 

revenue growth for fiscal 2010, with earnings, 

excluding items, in a range of $1.10 to $1.20 per share. 

The company will compete with companies such as 

Baxter International (Deerfield, Illinois), Hospira (Lake 

Forrest, Illinois) and Covidien (St. Louis). 






Corus offers noninvasive 

method to assess cardio ills 

By OMAR FORD 


For years physicians have assessed coronary artery 

disease (CAD) by reviewing a patient’s symptoms, medical 

history and cardiovascular risk factors, as well as use tests 

that yield anatomical and functional information about the 

heart and its vessels. 

While there have been tremendous advances surrounding 

the technologies that treat this disease, the diagnostics 

tools used to identify CAD hasn’t quite kept the same pace. 

A new test from CardioDX (Palo Alto, California) promises 

to give physicians far greater insight on a patient’s 

probability of having obstructive CAD. The company 

reported launching its Corus CAD test in select states, and 

that the test recently completed the PREDICT multicenter 

validation study. 

Corus CAD at its core is a genomic test that was developed 

after physicians expressed dissatisfaction with some 

of the shortcomings of imaging tests like stress echocardiography, 

myocardial perfusion imaging and computed 

tomography angiography. 

“We usually take a tremendous amount of time with 

physicians before we delve into the R&D phase of our products,” 

David Levison CEO and founder of the 5-year-old 

CardioDX told Medical Device Daily. “We asked physicians 

what were the challenges in the diagnosis and care of coronary 

patients.” 

The number one response the company received was 

that clinicians and doctors were trying to get a more objective 

look into identifying and predicting the occurrence of 

serious cardio disease, according to Levison. 

The company, once finding out what direction it should 

go in, started work on proving a hypothesis that there is a 

strong correlation between the peripheral blood gene 

expression and CAD. 

“Physicians said give us a test that has a very high sensitivity 

level so they can rule out any patients who might 

not be at risk,” he said. “Our test is much more objective in 

nature [than imaging tests on the market]. The result is 

going to be the same every time you run a sample, and not 

necessarily depend on how a clinician views an image.” 

To date the company has collected more than 2,800 

patient samples through PREDICT from more than 40 clinical 

sites in the U.S. Trial results and the Corus CAD validation 

data are expected to be presented toward the end of 

2009. 

Here’s how the test works: 

The clinician takes a simple blood sample, without 

exposing the patient to radiation, contrasts or dyes and it is 

then sent to CardioDx’s CLIA-certified laboratory for gene 

expression analysis. CardioDx scientists use quantitative 

31 

real-time polymerase chain reaction (qRT-PCR), a highly 

sensitive laboratory process for precise quantification of 

gene expression. Validated in a rigorous multi-center trial, 

Corus CAD integrates the expression levels of 23 genes 

and other patient characteristics empirically shown to indicate 

obstructive CAD. 

Results are delivered to the physician via a patient 

report that includes a numeric score between 0 and 40. 

“The higher the score the more likely obstructive coronary 

disease could occur in the patient,” Levison told MDD. 

He added that the test combines gene expression information 

with standard information from clinical assessments 

and enables physicians to have a “more complete 

picture” of their patient’s disease, and allows for more “individualized” 

and “informed” patient care decisions. 

As of now the test is only available in nine states 

Kentucky, Maryland, Illinois, Washington, Wisconsin, 

Minnesota, North Carolina, Texas and Arizona. Plans call for 

tests to be administered in more states next year. 

“With this test, for the first time physicians have the 

biology behind the imaging,” Levison said. “We’ve developed 

a test that is very actionable. It’s a test that can give 

physicians a [road map] to determine the next course of 

action for patients.” 

CardioDx is a cardiovascular genomic diagnostics 

company providing physicians with clinically validated 

tests to enable more informed and individualized patient 

care decisions. The company is strategically focused on 

developing products for three forms of cardiovascular disease: 

CAD, cardiac arrhythmias and heart failure. 

(This story originally appeared in the Aug. 27, 2009, 




32 

Electrode alternative: nanotech 

‘dots’ offer neural stimulation 

By DON LONG 


Putting electrodes in the brain, or other areas of the 

body, is frequently necessary but offering significant risks 

– and how much information or therapy, can they provide, 

and with what accuracy Offering what they believe could 

be a less-invasive, more flexible method for acquiring and 

stimulating neural activity is a research duo from Case 

Western University (Cleveland). The new method, they 

say, using nanotechnology, has the potential to understand 

and activate specific regions of the brain and other neural 

pathways, or potentially restore function to damaged or cut 

nerves. 

Ben Strowbridge, PhD, an associate professor in the 

neurosciences department at the Case Western Reserve 

School of Medicine, and Clemens Burda, PhD, associate professor 

of chemistry, have shown how semiconductor 

nanoparticles can excite neurons in single cells or groups 

of cells with visible, near-infrared light. Strowbridge told 

Medical Device Daily that these particles, “dots” essentially, 

could act as tiny solar cells for activating neural data and 

therapeutic response. 

The study, done with rodent brain slices under a microscope 

and then activated with an infrared light source, is 

early feasibility work, Strowbridge and Burda acknowledged, 

saying that it was peripheral to their main activities. 

And both describe the research result as a rather happy 

surprise. Burda, the chemistry expert of the team, told MDD 

that the next steps will be to embed the nanoparticles in 

live rodents and, ultimately, in humans. Another goal, he 

said, will be to show that the nanoparticles can be placed in 

both dispersed and targeted ways in order to light up and 

activate different neural sectors. This, the researchers 

believe, could be a new way of recreating the complex 

activity patterns that normally occur in the brain, and, 

importantly, doing it without wires or traditional electrical 

power. 

Traditional electrical stimulation of the brain, the 


researchers say, requires an array of metal electrodes to be 

implanted. But the closer the traditional metal electrode 

technique gets to re-creating “real” biological activity patterns, 

the more invasive it becomes. And the more electrodes 

used, the greater the risk of side effects, from 

destruction of cells to chemical reaction to the electrode 

materials. “There are many different reasons you’d want to 

stimulate neurons, such as repairing injury or restoring 

function to severed or damaged nerves. And right now you 

have to put a wire in there, and then connect that to some 

control system. It is both very invasive and a difficult thing 

to do,” Strowbridge said. 

Burda described the particles chosen for the work as 

“semiconduction quantum dots,” selected because of their 

ability to absorb long wavelength light, and thus easily irradiated 

or “stimulated.” Human tissue, he added, “is almost 

transparent in that wavelength range.” The work was 

launched three years ago, “essentially on the side,” Burda 

said, and turned out to be “more successful than we expected.” 

The result, he said, has been to create “a stimulation 

device that’s incredibly small” and can be implanted “anywhere 

in the body.” 

The team first combined the nanoparticles with glass 

to examine toxicity, and then to satisfy the demands of 

medical use, figured out how to encase the particles in 

glass for further protection, still managing to keep the particles 

at micrometer scale. That was done in the lab of 

Strowbridge, who supplies the biological expertise of the 

team. He said the system they developed “turned out to be 

very nice” and could ultimately be used to develop a better 

understanding of “how brain circuits are organized.” He 

explained that the actual implementation and applications 

of the system could be highly varied because of its great 

flexibility. The nanoparticles might be implanted surgically 

in the brain or somewhere just under the skin. The light 

source used to make them light up could range from 

implanted fiber optics to a handheld laser device, he said. 

Applications could range from research on the brain “to 

create more realistic input patterns,” to therapy: “Can you 

excite the nerves or brain pathways [to treat] spinal cord 

injury” To move the research beyond feasibility – and 

closer to full-time focus – he said that grants are being 




33 

sought to hire new staff that can pursue the system’s use in 

animal models. 

Strowbridge acknowledged that other methods are 

being researched as ways to avoid traditional electrodes. 

These include the exploration of biological systems that 

are light-sensitive; for instance, there is “a lot of excitement 

about genetic activation of brain cells.” But he said that this 

method is more complicated, would require a greater energy 

source and is more difficult to control. 

“Semiconductor particles” – by contrast – “offer much 

closer electronic access to the brain and have a very reliable, 

predictable response. That’s not so easy to get with 

biological methods,” Strowbridge said. But he said that 

whichever method proves more useful – and both may be 

quite serviceable, depending on the particular need, he 

acknowledged – an important intent will be to find ways to 

gather a larger, more accurate amount of neural data with 

less risk to patients than currently provided by standard 

electrodes. “The long-term goal of this work,” Strowbridge 

said, “is to develop a light-activated brain interface that 

restores function following nerve or brain impairments. 

Our findings may open up a whole new world of research 

possibilities.” The study was published in the journal 

Angewandte Chemie (Vol. 48, Issue 13, pp: 2407-2410). 

(This story originally appeared in the June 30, 2009 

edition of Medical Device Daily.) 



34 

Cepheid’s new GeneXpert 

identifies flu in 45 minutes 


By OMAR FORD 


Recent headlines and news reports have already 

ensured that the upcoming flu season is going to be one of 

the most significant in recent history. With all the attention 

that H1N1 is getting it’s no wonder that such a huge spotlight 

is being put on the various flu strains that are poised 

to plague the public. 

A new test from Cepheid (Sunnyvale, California) is due 

to get its chance in the spotlight too, since the company is 

calling it one of the first tests that can actually differentiate 

between each strain of influenza in a record time of 45 minutes. 

The company was able to receive an Emergency Use 

Authorization (EAU) by the FDA, for its Flu A Panel test for 

use on the GeneXPert System. The test is poised to provide 

a distinction in the specific presumptive identification of 

Seasonal H1, seasonal H3 and H1N1 novel strain types. 

“This test really comes in response to the needs of the 

time,” David Persing VP chief medical and technology officer 

at Cepheid told Medical Device Daily. “This is likely 

going to be a very confusing influenza season.” 

The EUA authority allows the FDA, based on the evaluation 

of available data, to authorize the use of unapproved 

or uncleared medical products or unapproved or uncleared 

uses of approved or cleared medical products following a 

determination and declaration of emergency, provided certain 

criteria are met. 

Subsequent to the EUA request for consideration by the 

FDA, the test would be made available in Europe as a CE IVD 

product, said the company. 

Following the EUA request to the FDA, development of 

Flu Panel test would continue by adding additional target 

identification for Flu B. For that product, a separate 510(k) 

submission is expected in 2010, according to a report from 

the FDA. 

Persing said that the test is set to improve on other 

polymerase chain reaction (PCR) tests in the market. 

“What we hope to provide is the same level of convenience, 

with a higher level of (accuracy),” Persing told MDD. 

The GeneXpert System is a closed, self-contained, fullyintegrated 

and automated platform that represents what 

the company calls a paradigm shift in the automation of 

molecular analysis, producing accurate results in a timely 

manner with minimal risk of contamination. 

The system is designed to purify, concentrate, detect 

and identify targeted nucleic acid sequences thereby delivering 

answers directly from unprocessed samples. 

Modular in design, the GeneXpert System has a variety 

of configurations to meet the broad range of testing 

demands of any clinical environment. Previously the company 

received clearance from the FDA to market the Xpert 

C. difficile test to run on the Gene Xpert System. 

But while Cepheid one of the first companies to develop 

such a test, it isn’t the first to develop a test. 

The first test to identify the different strains of influenza 

was developed by Focus Diagnostics (Cypress, 

California) the infectious disease division of Quest 

Diagnostics (Madison, New Jersey). The company said it 

released its lab-developed influenza A H1N1 (2009) Real 

Time RT-PCR in August (Medical Device Daily, Aug. 21, 2009). 

Focus’ test qualitatively detects the RNA of the 2009 

H1N1 influenza virus from a patient’s nasal, nasopharyngeal 

or throat specimen. In combination with clinical and epidemiological 

assessments, the test aids physicians in diagnosing 

patients infected with the pandemic virus rather 

than other influenza A strains. 

The test uses reverse transcriptase polymerase chain 

reaction, or RT-PCR, to amplify viral RNA to make it 

detectable in a specimen. It targets two separate regions of 

the hemagglutinin (H1) gene of the 2009 H1N1 influenza 

virus to differentiate the presence of the pandemic virus 

from seasonal human influenza A virus. If RNA of influenza 

A virus and the 2009 Influenza H1 gene are detected, the 

specimen is reported as positive for 2009 H1N1 influenza 

infection. 






Surgical training models skirt 

the mess of cadavers, animals 



Surgeons typically learn their trade or how to use a new 

device by peer-to-peer training in the operating room, 

which can be an expensive endeavor. They also get practical 

experience working on cadavers and animals. But the 

cadavers can be more than unpleasant and animal rights 

groups are increasingly vocal. 

What’s the alternative Lifelike models are being 

increasingly used to train both new surgeons as well as veterans 

who are learning how to use a new device. And 

they’re nothing like the hard plastic heart model you see on 

the doctor’s desk either. 

The Chamberlain Group (Great Barrington, 

Massachusetts) now produces more than 450 products 

ranging from an upper GI model that includes a mouth and 

nose leading to an esophagus, stomach and duodenum for 

endoscopic exploration to a beating heart. 

“There’s a big effort being made to use computer 

graphics, virtual reality and simulations to create an experience 

akin to what’s done in training of pilots,” company 

co-founder Lisa Chamberlain told Medical Device Daily. 

“They’re put into a simulator environment and it’s done for 

surgical and interventional training and some of it is very 

effective. But for the kinds of interaction that require direct 

tissue contact between the physician and trainee, that’s a 

much harder sell. So our goal in our work is to provide a 

reasonably affordable solution that addressees that handson 

tactile experience.” 

Made of silicone and other polymers, the demand for 

Chamberlain products is growing. The majority of model 

buyers are medical device manufacturers who need a 

mechanism to train surgeons on a new device. But now the 

products are being used for surgical training too. 

“It’s gone from a novelty and a way to demonstrate procedures 

to a much more prevalent form of training,” she 

said. “I’d like to think we’ve had some effect on the acceptance 

of these products by virtue of them being realistic 

enough.” 

With just a handful of similar companies in the world, 

Chamberlain and her husband, Eric Chamberlain, started 

the business a decade ago by chance. The company has 

continued to grow, seemingly unaffected by the downturned 

economy. 

“There’s a lot going on in the medical device industry 

and we’re doing OK,” she said. “I’m hearing more about 

price sensitivity, but we’re still up [in sales] over last year.” 

Both were previously in the visual effects industry for 

movies and television with credits such as Superman, The 

World According to Garp, Predator I and II, The Big Chill, 

Tootsie, Gandhi, Ghostbusters, and The Matrix. A colleague 

35 

in the silicone business supplied the Chamberlain’s names 

to a device maker who was searching for somebody to 

build a realistic model. 

“We didn’t have a background in this field,” she said. 

“After we got over the gross-out factor, it was very interesting. 

What’s funny about our backgrounds is that it has 

proved to be extremely useful and pertinent. We understood 

the technologies in frequent use by our clients.” 

Three of the company’s latest models include a sinus 

trainer, a comprehensive uterine robotic surgery trainer 

and the next generation of a Robotic System Skills Kit, a 

modular tool for practicing basic skills in robotic surgery. 

The Maxillary Clinical Sinus Trainer was recently 

designed for Entellus Medical (Maple Grove, Minnesota) to 

train ENT surgeons on the company’s new FinESS Sinus 

Treatment, a treatment for chronic sinusitis. 

Tom Ressemann, CEO of Entellus, said, “Before we had 

the trainers, we had to fly physicians in for a training session 

to work on cadavers, which is a logistic and expensive 

challenge. The trainer now allows Entellus to bring the 

training to physicians, which is much more convenient for 

these busy surgeons; and it saves time and money.” 

The sinus trainer has a life-like patient head and neck 

with key anatomical landmarks such as the maxillary 

ostium, uncinate process, ethmoid bulla, nasal septum and 

turbinates. The structure is derived from actual patient CT 

data which is then replicated as a 3-D model. The maxillary 

sinus anatomy differs slightly on each side of the trainer so 

that the trainee is not limited to just one anatomical situation. 

The Uterine Trainer and the Robotic System Skills Kit 

were developed for Intuitive Surgical (Sunnyvale, 

California) for training on the company’s da Vinci Surgical 

System. 

The Uterine Trainer allows physicians to practice robotic 

skills used in myomectomy (removal of uterine fibroid 

tumors), hysterectomy (removal of the uterus) and sacrocolpopexy 

(correcting vaginal vault prolapse). Following a 

practice myomectomy using the trainer, the physician can 

perform a colpotomy (separating the uterus from the vagina) 

which is a skill performed during a hysterectomy. The 

remaining vaginal canal may then be affixed to mesh and a 

sacrocolpopexy performed by attaching the mesh to the 

available sacral tissue. This trainer has a replaceable uterus 

which permits unlimited practice. 

“Virtually everyone who trains on a da Vinci system 

first sits down at a Chamberlain model,” she said. 

The models range in price, depending on the complexity 

and whether or not it’s an off-the-shelf model or one 

that’s been customized. 

Cardiovascular models are a big seller for the company. 

If one needs to train for coronary artery bypass (CABG), a 

heart and thorax can be purchased. 

“But the physician might need to puncture the skin, go 

between the skin and get to coronary arteries to perform a 



36 


bypass,” she said. “What we would make is the whole chest 

with replaceable skin, it might have a pre-made opening. 

But when you get to the heart, we made a slot that accepts 

the small vessel that can be replaced. It’s like a razor blade 

solution. You buy the razor and then have to buy blades.” 

The entire CABG training solution can cost $850 to 

$8,000 for the initial set-up (the razor), depending on 

whether a customer opts for a standard heart or beating 

heart in a thorax. Replacement coronaries (the blades) run 

about $15 a piece; graft vessels run $25 to $30. 

“The vast majority of our products are made in 

response to an inquiry, but once we’ve created a product, it 

remains viable in our catalog. We do a lot of off-the-shelf 

sales,” Chamberlain said. 

The company, which manufactures everything in 

house, has developed a rapid prototyping technology with 

3-D printing capabilities. Very often there’s a rigid component, 

which is made out of sheet plastic or other materials. 

“We can take CT scans and MRI data as 3-D CAD files 

and go out to a 3-D printer, to make a negative and then a 

mold,” she said. “Hearts are the biggest sellers. But we’ve 

made a lot with vein pads to teach IV and catheter insertion 

too.” 

With an ever-increasing need for realism, the company 

is hearing more inquiries from prominent surgical training 

institutions. 

“We’re growing as more minimally invasive procedures 

are learned and people are being trained,” she said. “But the 

inverse is happening too. We got a grant from the John 

Adams Institute to develop a trainer for open bowel procedures 

because so much is happening laparoscopically that 

resident fellows are faced with the ‘uh oh’ factor when they 

have to suddenly open the patients up for one reason or 

another. They are used to being trained on minimally invasive 

techniques [and they need to know how to surgically 

open the anatomy when necessary].” 






Cheetah’s Nicom system shows 

good results in stress test study 

By OMAR FORD 


A new study could give heart stress tests like Cheetah 

Medical’s (Tel Aviv, Israel) a chance at becoming the standard 

for patient care, replacing expensive and more difficult 

testing options. 

The study evaluated bioreactance-based noninvasive 

measurements during exertion; identified abnormalities of 

cardiovascular function and how it might be useful for 

indexing disease severity, prognostication, and for tracking 

responses to treatment in clinical practice and trials. 

Nearly 240 patients were observed in the study, which 

compared Cheetah Medical’s Nicom System to the traditional 

method of measuring oxygen consumption, through 

Vo2 tests which are obtained from analysis of expired 

gases. Results were published in the Journal of Cardiac 

Failure, the official journal of the Heart Failure Society of 

America (St. Paul, Minnesota) and the Japanese Heart Failure 

Society. 

“The issue is to determine a patient’s rate of heart failure,” 

Cheetah Medical CEO Yoav Avidor told Medical Device 

Daily. 

Bioreactance technologies are non-invasive and measure 

cardiac output, and other hemodynamic variables such 

as stroke volume, cardiac index, left ventricular ejection 

time and thoracic fluid content. 

The company said that the results from both methods 

correlated extremely well, demonstrating the potential to 

use the Nicom system to routinely monitor heart failure 

patients without the significant limitations of expired 

breath gas technologies. 

Cheetah said the study gave evidence Bioreactancebased 

noninvasive measurements of CO at rest and during 

exertion identified abnormalities of cardiovascular function 

consistent with those identified by VO2 and in prior 

studies using invasive CO measurements. This technique 

might therefore be useful for indexing disease severity, 

prognostication, and for tracking responses to treatment in 

clinical practice and in clinical trials. 

The problem with expired breath technologies and 

VO2 tests is that they are expensive and some physicians 

and clinicians have very limited experience with this type 

of technology. 

“These tests aren’t readily available and are expensive,” 

Avidor told MDD. “The other problem is that these tests are 

very difficult because you could stress the heart while 

administering the test.” 

But the Nicom system, which is FDA cleared and has 

been given the CE mark, is a much smaller and inexpensive 

way to measure cardiac output. 

“The sensors for the device are four double electrodes 

37 

similar in concept to an ECG and are placed on the back of 

the patient, creating a square like shape,” Avidor told MDD. 

“What we do is non invasively measure cardiac output, 

without putting too much stress on the heart.” 

The philosophy behind the device is to observe organ 

perfusion and oxygen delivery because these two factors 

drive changes in cardiac function, vascular tone, blood 

pressure respiration and urine output. Therefore, monitoring 

oxygen delivery provides key insight into the patient’s 

hemodynamic status in a more accurate and real-time fashion 

than any dependant proxy such as blood pressure, 

urine output, heart and the like. 

The company said that this information provides key 

clinical insight, especially in challenging hemodynamic 

clinical settings, or in those where such challenges may 

quickly occur and rapidly deteriorate. Understanding oxygen 

delivery in real time means understanding how to treat 

the patients’ heart function, fluid balance and respiratory 

function. 

But what happens next for the company and the 

device The answer is quite simple according to Daniel 

Burkhoff, MD, PhD. an Adjunct Associate Professor of 

Medicine at Columbia University Medical School (New 

York). 

“With the results of this study showing good correlations 

to oxygen consumption and several prior independent 

studies showing that peak cardiac power can be even 

more predictive of outcomes, we are encouraged that we 

will see these measurements used more often in a variety 

of settings,” he said. “Currently, the NICOM appears to offer 

the simplest solution for clinicians to measure cardiac output 

and power during exercise. We are planning a large 

multicenter study to confirm the prior smaller studies to 

prove the utility of peak cardiac power for predicting the 

risks of hospitalizations, the need for heart transplant, left 

ventricular assist devices and mortality.” 

Cheetah Medical specializes in non invasive cardiac 

output and hemodynamic monitoring. The company is private 

and was founded in 2001. 





38 

Mini BP cuff could disrupt 

surgical monitoring market 



DÜSSELDORF, Germany – A small Austrian company 

introduced an innovation for continuous blood pressure 

monitoring so simple that, once seen, you have to ask why 

no one thought to do this before. 

Yet this elegantly low-tech technique opens a new 

potential for adding existing technologies that taken 

together could disrupt the current market for blood measurement 

during surgery. 

CNSystems Medizintechnik (Graz, Austria) won FDA 

approval just one week ahead of the MEDICA 2008 exposition 

here for its CNAP Monitor 500, which measures arterial 

blood pressure via a sensor sleeve placed over the 

patient’s fingers. 

The monitor has been available for sale in Europe 

since June. 

Measuring blood pressure during surgical procedures 

is critical to monitoring the patient under sedation. 

When patient blood volume state is maintained in an 

optimum range, anesthesiology studies show post-operative 

recovery can be reduced from 17 days to just seven. 

The trend toward goal-directed fluid volume management 

is delivering improved patient outcomes and substantial 

savings for hospitals, which explains the steadily 

increasing competition and sales for cardiac monitoring in 

recent years. 

Currently the only technique for continuous blood 

monitoring of patients during operations is an invasive 

needle inserted into an artery that also has the advantage 

of providing blood gas measures but increases the risks for 

infection and has potential for damaging the artery 

The majority of patients in surgery are monitored 

using the traditional blood pressure cuff placed on the 

upper arm, which has the advantage of being non-invasive 

but the disadvantage that a reading can only be obtained 

every three to five minutes. 

“This method not only compresses the arm but also 

occludes the artery, and if you do it every three minutes to 

step up the frequency, you will have a lot of bruising,” 

explained Christopher Arbeiter, head of sales and marketing 

at CNSystems. 

He said a study conducted by CNSystems among 150 

German and 50 Austrian anesthesiologists found continuous 

monitoring with an arterial needle is used in 18% of procedures 

while the pressure cuff is used in 82% of surgeries. 

In its default setting, the CNAP Monitor 500 displays on 

a large, anti-reflective screen a high-fidelity blood pressure 

curve, the beat-to-beat blood pressure values, the patient’s 

pulse rate and then a trend view of blood pressure and 

pulse rate. 


With real-time continuous readings, CNSystems is targeting 

the 82% of procedures that already are non-invasive, 

using the blood pressure cuff. 

“We hope to upgrade the anesthesiologists to continuous 

information and then go after the 18% of arterial needle 

procedures where there is not a need for blood gas measures,” 

Arbeiter said. 

While selling the new monitor to hospitals through its 

own distributor network, CNSystems also supplies the 

CNAP Monitor 500 to original medical equipment manufacturers 

(OEMs). 

Three German companies who have integrate the unit 

into their own product lines are Draeger (Lübeck,Germany), 

Medis Medizinische Messtechnik (Ilmenau, Germany) 

and Enverdis (Jena). 

Draeger introduced the monitor at MEDICA as the 

Infinity CNAP SmartPod. 

Arbeiter estimated that less than 20% of the company’s 

current revenues are to these OEMs, “but we just started 

with Draeger,” he said. 

Ian Rowley, sales manager for the UK with APC 

Cardiovascular (Crewe, UK), said that since the European 

release of the product in June, he has sold six units. 

Arbeiter said CNSystems was too late to be included in 

the 2008 budget cycle for German and Austrian hospitals, 

but that it has had some success getting on the budget 

cycles for 2009 and that he projects the first strong wave of 

sales to come toward the end of next year. 

He said the company is negotiating with distributors 

for the U.S., but that his approach to the American market is 

to seek an “optimal market model.” 

Because this cuff slips over two fingers, there is the 

obvious possibility of integrating infrared sensors, which 

would provide oxygen saturation readings, Arbeiter said, 

explaining that inputs from the finger cuffs can be plugged 

into any existing surgical monitor. 

“This would become a very disruptive product for the 

SpO2 game” that is led by the Masimo (Irvine, California) 

and Covidien’s (Mansfield, Massachusetts) Nellcor 

(Boulder, Colorado) unit as the two biggest manufacturers, 

he said. 

“They have a good business selling probes, yet we only 

need to add software to our device to do the same thing, 

and that is a no-cost add-on feature,” he added. 

“So we are moving carefully right now in approaching 

the U.S. market, because there is more than one big company 

looking to do a crossover of their product with this 

device,” Arbeiter said. 

Asian markets are a low priority, he said, adding that 

the company is looking into opportunities for China, but 

that the hurdles are so high for entering the Japanese market 

that it will take some time to conduct required studies. 

“Europe and the U.S. are our focus, because that is 

where a company finds 75% of the global sales potential,” 

Arbeiter said, adding that he believes the sales potential for 




39 

the device in the U.S. is €185 million ($231 million) annually, 

and that Europe will be significantly less, with Western 

Europe projected to be €190 million ($112 million). 

The CNAP Monitor 500 is only the company’s second 

major product offering, he said. 

The centerpiece of its sales to date is a device for cardiovascular 

assessment called the Task Force Monitor, 

which non-invasively provides real-time diagnosis of neurocardiogenic 

syncope for measuring the therapeutic effectiveness 

of CRT-pacemakers, optimization of hypertension 

therapy, assessment of autonomic neuropathy in diabetes 

patients and in research and teaching. 

For 10 years CNSystems’ annual sales have hovered 

around €14 million ($5 million), Arbeiter said, and the 

growth curve will be gradual through 2009, when he 

expects to post a 50% gain to €16 million ($7.5 million). 

(This story originally appeared in the December 1, 2008, 




40 

Cochlear’s new implant FDA 

approved for adults, children 




Smaller is better when it comes to implanted medical 

devices. Cochlear (Centennial, Colorado) has just reported 

FDA approval of its smallest, most water resistant sound 

processor, the Nucleus 5 System for adults and children 

with severe-to-profound hearing loss. 

The new cochlear implant builds on the company’s previous 

devices which are able to restore hearing in deaf children 

and offers adults and children a cleaner sound in 

noisy environments as well as new options for phone use. 

“I just saw a surgery of one of the first done in the U.S. 

since we launched late last week,” Christine Menapace, VP 

of Clinical, Training & Education for Cochlear, told Medical 

Device Daily. “Most of the time, with cochlear implants, you 

can see a bump behind the ear. This design was made to 

naturally fit into an individual’s surgical space into the 

cochlea. It was implanted into a 22-month-old child and 

you can’t see the implant under the skin. Being a little bit 

smaller made a big difference.” 

The Nucleus 5 System is the fifth generation implant 

and an eighth generation sound processer that the company 

has produced since it first launched a Nucleus system 

which was FDA approved in 1998. 

“It’s 30% thinner than any other cochlear implant on the 

market and 40% thinner than our previous generation of 

implants,” said Teresa Adkins, VP of marketing. 

Although 36 million American adults report some 

degree of hearing loss, only one out of five people who 

could benefit from a hearing aid actually wears one, according 

to the National Institute on Deafness and Other 

Communication Disorders (NIDCD; Baltimore, 

Maryland). Most people with hearing loss prefer a device 

that’s not visible, but cochlear implants are reserved for 

people with profound hearing loss or total deafness. 

While the newer version is smaller, it retains the 22 

electrode arrays and “A very unique curved electrode array 

that allows for more focused listening,” Adkins said. 

Menapace said the company has focused a great deal 

of energy developing new input processing strategies to 

clean up and modify the signal for clearer sound. 

“The outcomes we’re seeing with this population in 

very difficult test environments, like at a noisy a cocktail 

party, are that they are doing better than any group I’ve 

ever seen.” 

Cochlear is currently designing large-scale studies to 

provide data that will back up its claims. 

The new version cochlear implant, Nucleus 5, includes 

SmartSound 2 technology with a new Set It and Go program 

for everyday listening and AutoPhone. 

Adkins explained that the AutoPhone technology addition 

automatically recognizes a phones system in a car so 

that the person need not push any buttons. “There’s plenty 

of room on ear to wear a Bluetooth and that’s boosted by 

the system,” she said. 

Set It and Go program is provided if a person doesn’t 

want to make adjustments in volume or sensitivity as their 

environment changes. But that option is there when needed 

for use, with a remote device that looks like a small iPod. 

“It’s useful for parents to monitor their child’s hearing 

to make sure the system is working well,” Menapace said. 

“You can see that it’s working appropriately, especially in a 

young baby. You want to be assured that they’re hearing 

you.” 

Remote assistance is another feature that allows for 

adjustments from home. In the past, if any modifications 

were needed to the system, a cochlear implant wearer 

would have to visit an audiologist. Many changes can now 

be made at home via the remote feature. 

One of the issues many people have with cochlear 

implants is poor pitch, which affects how a person listens 

to music and for people who speak tonal languages such as 

Cantonese and Mandarin because they contain tones that 

equate meaning. But Menapace said that Nucleus 5’s 22 

electrodes access 161 intermediate pitches, allowing for 

more precise hearing. 

“Hearing scientists all over the world are trying to 

determine how to make more electrodes fit in a very small 

space,” she said. “The cochlea is the size of a pea. Adding 

more electrodes means having the technology to allow us 

to do that. Scientists are working on thin film technology 

which will take away the bulk presented by use of silicone 

and titanium. We’re all hoping and waiting for that to 

advance.” 

She added that Cochlear is currently working to 

advance that technology to allow for more electrodes and 

even better hearing results. 

Other companies in the cochlear implant space include: 

• Advanced Bionics (Sylmar, California), which 

received FDA approval to market the Clarion Multi-Strategy 

Cochlear Implant in 1997. 

• Med-El (Research Triangle Park, North Carolina), 

which makes the FDA-approved Combi 40+ Cochlear 

Implant System. 

• Symphonix Devices (San Jose, California), which 

makes the Vibrant Soundbridge, FDA approved in 2000. At 

the time, the agency called it the first implantable hearing 

device approved in the U.S. to treat moderate to severe sensorineural 

hearing loss the result of hair cells, or nerves in 

the inner ear, being damaged. This type of hearing loss 

affects the vast majority of people with hearing loss. 






Coherex FlatStent EF PFO 

closure device wins CE mark 



After using a new PFO closure device on opposite sides 

of the globe, two cardiologists say they are not surprised 

that the Coherex FlatStent EF PFO Closure System has 

received a CE mark for use in closing patent foramen ovales 

(PFOs). 

Coherex Medical (Salt Lake City) reported Wednesday 

that the device has been granted a CE mark for use in 

Europe and other countries to close PFOs, a common defect 

found in roughly 20% of the worldwide population. 

Although many adults with PFOs never have any problems 

because of the defect, the condition is linked to strokes and 

migraine headaches. 

Coherex said it has begun initial efforts to ramp-up 

sales and marketing in Europe for the FlatStent EF device. 

According to the company, the device is similar in use and 

function to self-expanding vascular stents that are widely 

used by interventional cardiologists. However, the Flat- 

Stent EF device combines a planar nitinol structure with a 

polyurethane substrate in a unique fusion of PFO closure 

mechanisms designed with the intent to naturally seal PFO 

tunnels, Coherex said. 

The company believes it is the first device cleared by 

any regulatory body that operates almost entirely in the 

PFO tunnel, allowing doctors to treat the condition from 

within the PFO tunnel itself. “Current devices on the market 

are not bad devices, but they are an older technology,” 

Randall Jones, MD, chief medical officer at Coherex, told 

Medical Device Daily. He said all of the current devices for 

PFO closure are at least 15 years old and were developed 

originally to close atrial septal defects, not necessarily 

PFOs. With the FlatStent EF device, Jones said, “we’re just 

treating the tunnel, not the whole septum.” 

Compared to older devices, the FlatStent EF contains a 

lot less foreign material and therefore there are fewer 

chances for problems, Jones said. Horst Sievert, MD, principal 

investigator of the COHEREX-EU clinical study using the 

FlatStent EF system, said the device is unique among PFO 

closure technologies in the way it is used to repair PFO. 

“The most common approach taken today for repairing 

a PFO is to use a device that clamps two metal mesh-like 

disks on either side of the PFO opening, with these disks 

exposed inside the left and right atria (or upper chambers) 

of the heart,” Sievert said. “And to be clear, this approach 

works. However, anytime you insert any foreign object into 

the heart, there are several risks, including: blood clot formation, 

damage or erosion of the septal wall that separates 

the left and right atria, and even the potential for interfering 

with the electrical signals within the heart muscle 

itself.” 

41 

Sievert said these risks appear to be reduced with the 

Coherex FlatStent EF device. “In fact, the Coherex FlatStent 

EF is the first in-tunnel device to receive regulatory clearance 

for PFO closure,” he said. “Its rapid exchange system 

allows a physician to deliver the nitinol and polyurethane 

structure of the FlatStent EF quickly and easily to the PFO 

where it can easily be maneuvered within the PFO tunnel 

before its anchors secure it into place — and that’s the key. 

As a result, there is very little exposed surface area within 

the left atrium, little or no damage to the septal wall, and 

significantly less metal mass than current devices. The 

rapid exchange design also reduces the risk of introducing 

an air embolism into the left atrium by eliminating the need 

for a large bore delivery catheter common to other 

devices.” 

The COHEREX-EU study – a clinical trial conducted by 

Coherex to pursue CE mark clearance for the device – was 

conducted at sites in Germany, Switzerland, New Zealand 

and Australia. Sievert is the director of the CardioVascular 

Center Frankfurt, Sankt Katharinen, and the Department of 

Internal Medicine, Cardiology and Vascular Medicine of the 

Sankt Katharinen Hospital (Frankfurt, Germany). He is also 

an associate professor of internal medicine/cardiology at 

the University of Frankfurt. 

Another physician who participated in the study was 

Peter Ruygrok, MD, clinical director of the Green Lane 

Cardiovascular Service at Auckland City Hospital 

(Auckland, New Zealand). Ruygrok is also on staff at the 

Auckland Heart Group, a private cardiology practice in New 

Zealand. 

“I was delighted with the high rate of closure immediately 

after implantation, something I was not expecting, 

but I suspect we saw such results because the Coherex Flat- 

Stent EF functions almost entirely within the PFO tunnel,” 

Ruygrok said. “Six months after implantation, it was clear 

the Coherex device functioned exactly as we had anticipated 

– the PFO tunnels were closed, there was no more shunting 

of blood from the right to left atrium, and no damage to 

the septal wall. The final results were very encouraging and 

that’s what I was hoping for from an in-tunnel device like 

the Coherex FlatStent EF.” 

A foramen ovale is a tunnel-like opening between the 

upper chambers of the heart that allows blood to bypass 

the lungs and is present in all fetuses, Ruygrok said. 

Normally, the foramen ovale closes soon after an infant is 

born. However, if this opening fails to close naturally after 

birth the opening is said to remain patent and the defect is 

called a PFO. 

Trent Loveless, CFO at Coherex, told MDD that the company 

has been in discussions with FDA and is also working 

with world leaders in neurology and cardiology in an effort 

to design a migraine trial, which could show a connection 

between migraine and PFO and being able to improve the 

symptoms of migraine using this device. 

“We anticipate being able to begin a trial with FDA in 



42 


the near future, although we don’t have any fixed dates that 

I can give you at this time,” he said. Coherex has already 

begun its initial efforts to ramp-up sales and marketing in 

Europe for its Coherex FlatStent EF, and the company 

expects to make future announcements about its progress 

as it moves forward in these areas. “Although there are a 

handful of older, legacy devices cleared for closing PFOs, 

these devices are significantly larger than the Coherex 

FlatStent EF and they close PFOs by completely overlapping 

PFO openings on both sides of the septal wall,” Richard 

Linder, Coherex president/CEO said in a company statement. 

“Conversely, by its very design, the Coherex FlatStent 

EF represents the next generation approach to PFO closure.” 

Linder added that the FlatStent has “dramatically less 

mass and less exposed surface area” than other PFO closure 

systems and is deployed almost entirely within the 

PFO tunnel – the exception being two tiny anchors. 

“The device works just like it was designed to and really 

offers patients a benefit and advantage that they haven’t 

had until now,” Jones said. 






FDA gives green light for AVIVO 

cardio-monitoring by Corventis 

By OMAR FORD 


Patients are told all the time to be proactive with their 

health, by having annual check-ups and living a healthy 

lifestyle, but what if a med-tech company made a device 

that was proactive in the early detection of illnesses that 

could plague the heart. 

The what-if became a reality last week when 

Corventis (San Jose; California), a venture-funded medtech 

company started in 2005, reported FDA clearance for 

its AVIVO Mobile Patient Management System. 

AVIVO is a non-invasive, wireless system that monitors 

cardiovascular conditions. It is the company’s inaugural 

product and Corventis describes it as a platform system 

that helps to identify the company’s fundamental technological 

focus. 

“This is the first of two to three products we intend to 

launch,” Ed Manicka, president/CEO of Corventis told 

Medical Device Daily. “AVIVO actually watches the patient 

and monitors the heart. What we’re trying to do with the 

device is catch things in the patient before they occur and 

have an adverse effect.” 

AVIVO looks somewhat like a small Band Aid that is 

placed on the patient, but to call it that would be a grave 

misnomer, according to Manicka, since it could have much 

more than Band Aid-like impact. The company says it 

believes that this device could have tremendous cost saving 

benefits for patients and the healthcare industry as a 

whole. 

The device utilizes the company’s PiiX wearable sensor 

– key to the device’s ability to provide continuous ambulatory 

monitoring – providing insight into cardiovascular 

health during a person’s normal daily routines. The PiiX 

sensor automatically collects physiological information 

and wirelessly transmits the data from the patient to 

Corventis – at either its London or San Jose offices — for 

further analysis and presentation on a secure website. 

Currently electrocardiograms (ECG) and other tests 

performed in a hospital or clinic setting provide valuable 

information about the rhythm of the heart and overall 

patient health status. In many cases, however, it is necessary 

to monitor heart rhythm or other physiological signals 

for a longer period of time for a better understanding of the 

patient’s condition. But this is cumbersome with many current 

technologies. 

Because having no leads and wires, PiiX encourages 

patient-friendly, continuous wear, and it can be worn even 

while showering or sleeping. Automated collection and 

transmission of data also minimizes the number of steps 

required by the patient to ensure reliable event detection, 

according to the company. 

Corventis says that its wireless technology offers 

“ongoing visibility” into a patient’s cardiac health status, 

previously accessible primarily with invasive implantable 

devices. 

Multiple sensors on the PiiX enable what the company 

calls “intelligent detection” of clinical events and the creation 

of “comprehensive heart rate, respiratory rate, fluid 

status, and posture and activity trends. Clinical event information 

such as ECG is captured on an “exception” basis, 

according to the company, providing focused review and 

diagnosis by clinicians. 

There is a huge market for the device. More than two 

million Americans have atrial fibrillation, a cardiac arrhythmia 

increasingly being seen as putting a person at risk for 

stroke. And nearly 835,000 Americans are discharged from 

hospital care with cardiac arrhythmia diagnoses each year. 

Corventis was founded to primarily serve the cardiac 

health market – thereby deriving its name. 

“’Core’ is Latin for heart, and ‘ventis’ stands for innovation,” 

Manicka said. “So Corventis means to be at the heart 

of innovation.” 

The company is funded by venture capital firms 

Kleiner, Perkins, Caufield & Byers, Mohr Davidow Ventures 

and DAG Ventures. 

“We are very proud of our accomplishments to date, 

including filing more than 50 patents internationally, 

deploying our solutions around the globe, successful 

enrollments in our clinical program and receiving this FDA 

clearance for our technology. The elegant solution we have 

developed will serve as a platform for multiple future products 

designed to improve the way heart conditions are 

managed,” Manicka said. 

“I see us fundamentally transforming healthcare by 

adding the Internet into the management process.” 

(This story originally appeared in the April 30, 2009, 


43 



44 

CVRx enrolls first patient in 

HF trial with Rheos System 



CVRx (Minneapolis) reported the first enrollment of a 

patient in the HOPE4HF trial, a study that is evaluating the 

company’s Rheos System to treat heart failure. The 

implantable device is already approved for treating hypertension 

patients in Europe. 

The Rheos uses baroreflex activation therapy technology, 

a non-pharmaceutical approach designed to treat cardiovascular 

disease, according to CVRx. The HOPE4HF trial 

is being conducted under an approved investigational 

device exemption from the FDA. The company expects that 

the trial will support a pre-market approval application to 

the FDA for use of the Rheos System in heart failure. 

“Often startups are about one product, one application,” 

Nadim Yared, president/CEO of CVRx, told Medical 

Device Daily. He said the HOPE4HF trial is important to 

CVRx because it means the company no longer offers just 

one product for one therapy. Now, the company has one 

platform with multiple applications, he said. 

The Rheos has already been evaluated in patients with 

drug-resistant hypertension, or high blood pressure. 

Results from European and U.S. feasibility clinical studies 

have shown it can significantly reduce blood pressure over 

a three-year period and the device is well tolerated, CVRx 

said. Results presented at the European Society of 

Hypertension documented systolic blood pressure was 

reduced by an average of 37 mmHg at three years. The 

Rheos hypertension pivotal trial is evaluating the device in 

300 patients with resistant hypertension; enrollment will 

be completed this year, the company noted. 

“After promising data from previous U.S. and European 

hypertension trials evaluating the Rheos System showed 

improvement in heart structure and function, we are excited 

to expand this therapy to heart failure,” Yared said. 

“Today, many heart failure patients have no proven treatment 

options. We are hopeful the Rheos System will 

improve their quality of life, and reduce hospitalizations, as 

well as the risk of death.” According to CVRx, heart failure 

affects about 5 million people in the U.S., and its frequency 

is growing with an aging population. 

HOPE4HF (Health Outcomes Prospective Evaluation for 

Heart Failure with left ventricular ejection fraction equal to 

or greater than 40%) is a Phase III, 500-plus patient study 

designed to gather clinical data on the efficacy and safety 

of the Rheos compared to the current standard of care in 

patients with symptomatic heart failure and a preserved 

ejection fraction. This type of heart failure, often called 

diastolic heart failure, causes the heart to become stiff and 

thick, and prevents it from filling properly with blood, the 

company said. Diastolic heart failure accounts for up to 

50% of heart failure cases, according to CVRx. 


“We are proud to enroll our first patient and participate 

in this landmark clinical trial,” said William Wickemeyer, MD, 

of Iowa Heart Center (Des Moines), who is an investigator in 

the HOPE4HF trial and enrolled the first patient in the study. 

“In the absence of approved drugs or devices to treat this 

type of heart failure, there is a definite need for a new treatment 

option, and Rheos therapy offers hope to these 

patients.” 

In addition to assessing the safety of the device, the 

HOPE4HF trial is designed to determine whether it provides 

the following benefits to heart failure patients: reduction of 

heart failure symptoms and improvement in quality of life; 

extension of life expectancy; improvement in heart function; 

and reduction in the number of hospitalizations and 

emergency room visits due to heart failure. 

“We are extremely excited. We are confident about the 

data, as you can tell by the tone of my voice, it’s a great day 

for us,” Yared told MDD. “We wouldn’t do it if our confidence 

was not high enough in the high blood pressure . . . we’re 

excited.” 

The Rheos uses baroreflex activation therapy that is 

designed to trigger the body’s own natural blood flow regulation 

system to treat heart failure and high blood pressure. 

If the system is shown to affect the body as intended, 

it offers the potential to reduce the risk of death and 

improve quality of life in patients with heart failure, according 

to CVRx. 

The Rheos works by electrically activating the baroreceptors, 

the body’s natural blood flow regulation sensors 

that regulate cardiovascular function. These baroreceptors 

are located on the carotid artery. When activated by the system, 

signals are sent through neural pathways to the brain, 

which responds to these signals by telling the arteries to 

relax, making it easier for blood to flow to the body and 

reduce effort on the heart; heart to slow down, allowing 

more time for the heart to fill with blood; and kidneys to 

reduce fluid in the body, lowering excessive blood pressure 

and reducing workload on the heart. 

“There is one class of evidence today to support a 

treatment for this disease and that is to treat the high blood 

pressure . . . and that is exactly what our device does,” Yared 

said. 

This system includes three components: a small device 

that is implanted under the collarbone; two thin lead wires 

that are implanted at the left and right carotid arteries and 

connected to the device; and the Rheos programmer system, 

an external device doctors use to noninvasively regulate 

the activation energy therapy from the device to the 

leads. The therapy can be adjusted to meet each patient’s 

individual needs as they change over time, providing personalized 

treatment, CVRx noted. 

“Diastolic heart failure is a major, growing public health 

problem with an urgent need for effective treatment 

options,” said Michael Zile, MD, of the Medical University of 

South Carolina (Charleston), who is one of the steering 




45 

committee members for the trial. “The HOPE4HF trial is a 

well designed clinical trial that will provide clinicians with 

the evidence to determine if the Rheos System provides 

effective treatment for these patients.” 

Some patients enrolled in the Rheos hypertension feasibility 

studies also have early stage heart failure, the company 

noted. The system was found to reduce the thickness 

of the heart and improve heart function in many of these 

patients. 

Because the HOPE4HF trial is just beginning to enroll 

patients and is intended to be a large trial of about 500 or 

more patients, Yared said the company does not really 

know yet how long it will take to complete the trial. 

However, he did say the company plans to start commercial 

efforts for the Rheos for high blood pressure before 

the heart failure study is complete. He estimated that there 

might be roughly two years difference between the two 

therapies going to market. 





46 

DiFusion offers fine-tunable 

ortho infection-fighting system 

By DON LONG 


It pays to be nimble. It pays to be quick. 

Derrick Johns, president/CEO of the newly launched 

company DiFusion Technology (Austin, Texas), says that 

the company is one of those start-ups that is nimble and 

that plans to be very quick to market with its new technology. 

That technology is a device for preventing surgical site 

infections (SSIs) following orthopedic surgeries and thus 

capable of saving the U.S. healthcare system $100,000 per 

SSI incidence, adding up to millions of dollars in savings 

every year. 

DiFusion reported its official rollout today, though the 

primary idea for the technology “began percolating” just 

two years ago, Johns told Medical Device Daily. And Johns 

said that DiFusion is expecting to get its product to market 

in just about six months via the 510(k) pathway. 

DiFusion’s technology is a basic interbody “cage” type 

of device used in orthopedics, but impregnated with an 

infection-fighting compound that Johns says is “picketfence”- 

protected by strong patents. 

As a case study of the need for this combination, Johns 

cites the sports fan-familiar case of Tom Brady, the quarterback 

of the pro football New England Patriots who was 

sidelined this year as the result of knee surgery and followon 

infection (a Pats fan himself, Johns admits that his 

friends might be getting a little tired of lamenting this particular 

medical case). 

He notes reports of further complications and repeat 

procedures which may keep Brady off the field in the ’09 

season. And these complications are costly, very famously 

to NFL quarterbacks but also to every hospital where these 

surgeries take place. 

DiFusion says the compound formulation used in its 

device — which it has dubbed “super silicate” — is capable 

of killing off 650 types of bacteria, including MRSA (methicillin-resistant 

Staphylococcus aureus), in the local surgical 

wound up to four weeks following the procedure. 

“In large studies, five out of 100 spine cases result in 

SSIs, often leading to second surgeries that are extremely 

costly and difficult for the patient,” said Matthew Geck, MD, 

an Austin orthopedic surgeon who is a member of 

DiFusion’s board. 

Rather than being a drug product, the material, Johns 

told MDD, is a silicate molecule “that we compound into the 

plastic [of the cage] itself. We load that with different ions, 

with antimicrobial components.” 

This material then will “diffuse in and around the soft 

tissue within four to six weeks,” he said,” and that the rate 

of diffusion can be “fine-tuned – like an FM radio – partsper-billion 

to alter the dose and time frame. 


“We can now effectively tune that molecule to elute silver 

and zinc ions to help the bone growth process.” 

DiFusion licensed the compound from AGion 

Technologies (Wakefield, Massachusetts) – providing silverbased 

anti-microbials for everything from air conditioning 

ducts to Yoga mats. Johns said the super-silicate compound 

was not being developed by AGion and was just “sitting on 

the sidelines,” though strongly patent-protected. 

“The controlled delivery of cationic elements possible 

with our ‘super-silicate’ offers multiple promising applications, 

from infection control to bone growth,” said Gary 

Ghiselli, MD, a Denver orthopedic surgeon and chair of the 

DiFusion scientific advisory board. 

Ghiselli cites figures indicating that SSIs cost the U.S. 

healthcare system $5 billion annually and that DiFusion’s 

system could save “$150 million in the spine segment 

alone.” 

Besides helping to avoid expensively treated infections, 

the technology fits the recent new wave created by 

the Centers for Medicare & Medicaid Services which will 

deny payment to hospitals for the treatment of infections 

that could have been avoided. 

This may be another reason why DiFusion expects the 

FDA to give the technology fairly rapid clearance via the 

510(k) pathway. 

Johns said the company has held pre-filing meetings 

with the FDA to share its data and that a 510(k) filing should 

enable marketing some time near the end of the first half of 

this year. 

He said the company then has two options: utilizing 

partnerships it has developed with an array of distributors 

around the U.S., or selling the product to a larger company, 

such as one of the major orthopedic firms. 

DiFusion has already begun conversations with those 

larger firms, but that this remains a “Plan B” type of opportunity, 

Johns said. 

The company received $840,000 in seed-state venture 

funding last July and said it is hoping for additional funding 

of up to $2 million to carry it into the marketing stage. 

(This story originally appeared in the Jan. 6, 2009, edition 





Enfant test measures children’s 

brain response to visual stimuli 

By OMAR FORD 


Vision impairment is an ailment that can go undetected 

in a child. Their suffering is quiet. The symptoms are hardly 

noticeable and the infant often is not in a position to let 

the parent know what’s happening until it’s too late. 

A test developed by Diopsys (Pine Brook, New Jersey), 

a small med-tech company, known for providing visual 

technology for patients, is giving parents a better tool for 

determining if their children suffer from vision impairment. 

The Enfant Pediatric Visual Evoked Potential 

Technology (VEP) vision testing system is non-invasive and 

is geared toward children who are six months of age and 

older, in order to detect visual deficits such as strabismus, 

optic nerve disorders, and severe refractive errors, which 

could lead to amblyopia. 

Amblyopia, or “lazy eye,” is the loss of one eye’s ability 

to see details. It is the most common cause of vision problems 

in children. 

“The big problem is that of the 200,000 children each 

year that suffer from amblyopia, only 4% are picked up in 

time,” Don Lepone, executive VP/COO of Diopsys told 

Medical Device Daily. “If you catch the fact that the child has 

amblyopia early then you can fix it, if you catch it late then 

you can’t fix it at all.” 

Most tests look at the eye to determine if there’s a problem, 

but in many cases the visual look of the eye isn’t the 

telling feature behind the problem. What is, according to 

Lepone and Diopsys is the way the image is relayed to the 

brain. This theory serves as the basis behind the company’s 

technology. 

The test has three sensory pads placed on the patient’s 

head, while an operator begins the test. Cartoon characters 

appear and music plays while a series of lines stimuli are 

presented to the child on a video display. The device then 

measures the health of the circuitry of the nerves, those 

visual pathways that send signals to the brain. 

The vision test does not require dilation or sedation, 

and is a painless, safe test. The Enfant is the only objective 

vision testing device capable of evaluating the entire visual 

pathway available today. Most insurance plans will pay 

for Enfant, which takes a total of five minutes for the 

patient to complete. 

“So what we do is stimulate each eye and compare the 

electrical energy through an algorithm,” Lepone said. 

At the end of each test, a pass or fail result is shown on 

the operator screen in both graphic and numeric formats. The 

results are then printed out for the patient’s medical record. 

The Visual Evoked Potential Technology (VEP) behind 

the Enfant was originally developed in 1983 by the 

Rockefeller University Laboratory of Biophysics 

(New York). 

This technology was licensed to NeuroScientific, 

which in 1986 merged with Neurotech, a small publicly 

traded company. 

At Neurotech, the VEP technology was updated and 

enhanced. The first systems created were the Venus and 

the Enfant. Both systems were sold worldwide to large 

research institutions, teaching universities, and large clinical 

practices. Many of these systems remain in use today. 

Diopsys acquired the rights to the VEP technology in 1998. 

Upon completing additional engineering work, a new 

prototype of the Enfant was developed, making it a functionally 

enhanced, easy-to-use version of the original systems. 

In 2002, Phase IV clinical trials, conducted by leading 

pediatric ophthalmologists, were completed at five leading 

eye care medical centers. 

After extensive on-site testing in 2003, the Enfant was 

officially launched at the October 2004 annual meeting of 

the American Academy of Pediatrics (Elk Grove Village, 

Illinois). 

The Enfant pediatric vision testing system is now available 

for pediatric practices nationwide. 

To date there are nearly 350 Enfant tests out in the 

states and the company expands on that number on a daily 

basis. It has been a slow but successful burn – as the company 

received FDA approval for Enfant back in February of 

2003. The reason is an initial lack of funding to support 

marketing for the device. 

But plans call for the company to work on releasing a 

new test also based on the VEP technology. 

The Diopysis Nova–Transient Response test, or the 

Nova-TR is being evaluated in Virgina and is being used to 

test soldiers who have been injured in Afghanistan or Iraq 

by Improvised Explosive Devices. The Nova-TR System also 

evaluates a patient’s response to an external stimulus 

along the entire visual pathway from the lens of the eye to 

the visual cortex of the brain. By using VEP, the Nova-TR is 

able to identify optical/neural abnormalities related to 

vision that an Optometrist might not otherwise be able to 

detect. The Nova-TR allows the clinician to objectively document 

response to therapy. 

“Some of these [troops] have suffered from concussions 

that are so severe that the brain ends up being traumatized,” 

he said. “This test will determine what if any problems they 

could have with their vision as a result of this.” 

Lepone said that the ball is rolling to bring more exposure 

to Diopsys’ products in the future and that now it is in 

a better marketing position to accomplish this goal. 

“We’re a relatively small company and this has been a 

six or seven year product development path,” Lepone said. 

“But when you don’t have a lot of money you boot strap 

your company along and prove your technology. Now we’re 

in a position where we’re cash flow positive and we can get 

behind some [stronger marketing efforts].” 



47 



48 

Draper Laboratories developing 

hand-held, point-of-care TB test 



Tuberculosis (TB) is still a killer in developing countries 

with one of the primary hurdles to controlling disease 

spread being a fast, cost-effective diagnostic tool. Draper 

Laboratories (Cambridge, Massachusetts) is about to 

start a human trial to test a hand-held, point-of-care TB testing 

device that has already been used for several years by 

the military in biodefense applications. 

“We see that in the future Differential Mobility 

Spectrometry (DMS) will eventually be able to determine if 

someone is infected with TB just by exhaled breath, but 

that’s in the experimental stage. What we’re working on 

now is to identify TB from sputum,” Jose Trevejo, MD, senior 

biomedical scientist, Bioengineering Division at Draper, 

told Medical Device Daily. “A lot of infections are detected 

using ELISA. But there’s something about TB’s biology that 

the standard approach of using antibody detection doesn’t 

work well. We’ve come up with a new approach to detect 

the biomarkers.” 

The Centers for Disease Control and Prevention 

(CDC; Atlanta) reports that more than nine million people 

get sick each year with the TB bacteria that usually attacks 

the lungs and almost two million die. The tests currently 

available to diagnose TB are a sputum culture, a skin test 

and a blood test, all of which require trained healthcare 

workers, special lab equipment and the need for patients to 

return for a follow-up. 

“I think the DMS would have a huge impact on the global 

TB situation,” Trevejo said. “There’s a huge need. I went to 

an international meeting last year and physicians there told 

me they have a lot of problems diagnosing TB. The gold 

standard that’s more sensitive, a culture, takes one to three 

weeks, is expensive and requires an advanced facility. Most 

of the time it’s not feasible, testing takes too long and they 

lose the patient in follow-up. They need something rapid. 

This could be a paradigm-shifting technology.” 

The DMS technology is currently used by the military 

and through a license to Sionex (Bedford, Massachusetts). 

“It’s a MEMS [microelectromechanical systems] chip 

that’s the size of a dime. It has a small sensor,” he said. 

“When you introduce volatiles, it detects ions. Fully assembled 

prototypes are as small as a deck of cards.” 

He explained that the DMS technology is different from 

electronic noses, which work by pattern recognition. 

“This is more like mass spectrometry, the gold standard, 

and has similar sensitivities,” he said. It rapidly analyzes 

volatile organic compounds (VOC) in the sputum or 

breath. 

“To date we have identified over 16 VOCs associated 

with TB,” he said. “For the initial development we focused 


on three compounds which were expressed in the highest 

amount.” 

Trevejo said Draper is collaborating with the 

University of Texas (Brownsville) to initiate a 25-patient 

study in Mexico within the next six months. If all goes well, 

a larger trial will be initiated. Upon clinical validation, his 

team will start the regulatory review process. 

He speculated that the device, with an approximate 

one-year lifetime, would cost $1,000 to $2,000 and individual 

tests would cost as little as $1. 

Trevejo said other teams around the world are working 

on point-of-care TB diagnostics, but, “We think our instrumentation 

is much more advanced. We have a good lead on 

the biomarkers and it will enable us to identify the bacteria 

with more sensitivity too. Our main advantage is that our 

devices are already portable, already sensitive and potentially 

point-of-care.” 






Drexel makes portable, radiationfree 

breast cancer detector 

By OMAR FORD 


The only approved FDA breast cancer screening system 

in the U.S. is mammography beginning at age 40 for 

women. The main issue is the effectiveness of the screening 

device is often substantially lessened in women with 

dense breast tissue. The mammogram also provides little 

to no information on the stiffness or mobility of a tumor 

and has a sensitivity level of 85% but in dense tissue 

breasts that decreases to 65%. 

Researchers at Drexel University (Philadelphia) are 

vying to bring their developed breast cancer detector to 

market, a device which could overcome the limitations of a 

mammogram and provide a portable and radiation free 

alternative to the clunky devices. 

The detector is based on piezoelectric fingers, an elastic 

and shear modulus sensor developed at the university. 

The proposed screening tool will be positioned as an 

early breast cancer test to be used by physicians and gynecologists 

in the clinical setting in conjunction with the 

physical examination. It supplements mammography to 

screen early for breast cancer in women with dense-tissue 

breasts. 

“We have been working of this for quite a long time,” 

Wan Shih PhD, a breast cancer survivor and an associate 

professor in Drexel’s School of Biomedical Engineering, 

Science and Health Systems told Medical Device Daily. “I 

envisioned this device in the early 2000’s. The device was 

not originally intended to detect breast cancer. I was envisioning 

a device that could measure the elasticity of tissue.” 

But five years into the program Shih changed the focus 

of the device and geared it more toward detecting breast 

cancer, a disease which she survived. 

Shih said that the PEF device is comprised of a handheld 

probe with small electrical measurement units that 

can be operated by a laptop computer. 

Here are some highlights of the device: 

• Palpation-like tissue stiffness imaging both under 

shear and under compression with less than one-millimeter 

spatial resolution up to a depth of several centimeters. 

• Use of the shear modulus/elastic modulus ratio to 

measure tumor mobility to screen for malignancy. 

• It has demonstrated more than 90% correlation 

between the shear/elastic modulus ratio and tumor malignancy 

– a capability all existing technologies lack. 

• With a single or double 1.5 cm wide PEF of depth sensitivity 

of 3 or 6 cm, it can probe for breast cancer for 

almost all body types. 

• Patients are in a supine position which poses no discomfort. 

• The PEF is gentle. It only works with less than 1% 

strain, which would cause minimal discomfort to the 

patient. 

Researchers are also saying that there are cost benefits 

for using the device as a pre-screening system. The 

portable system much would be much cheaper and require 

fewer operators than ultrasound, MRI and nuclear medicine 

tests. 

Plans call for Shih to make bid for the device to be commercialized 

and seek FDA clearance. 

“There are several entrepreneurs talking with us about 

licensing the technology,” she said. “As for FDA approval 

right now we’re planning on having clinical trials in India 

and China. And the reason we want to go in to those places 

is because there are a higher percentage of women with 

dense breast tissue in China than in the U.S.” 

Ultimately the goal is to have a calculator-size electrical 

measuring unit and a less than a less than 5” x 5” x 5” 3-D 

automation unit to operate the PEF. This imaging tool will 

help the physician locate smaller breast tumors than the 

current technologies and screen for tumor malignancy at 

the same time to save lives. 

As to when the device would actually hit the market, 

Shih said it would be realistic to think that we could see it 

in clinics in about five years. 

Shih added, “It’s really not complicated. It’s not radioactive 

and it’s very friendly to the human body.” 

(This story originally appeared in the Sept. 28, 2009 


49 



50 

The strategy: occlude vessels 

feeding prostate cancer cells 

By DON LONG 


James Bond lies tied down, legs spread, a laser pointed 

at his nether regions (remember that scene from 

“Goldfinger”). 

That disturbing image just might pop into the mind of 

a prostate cancer patient, when told of the therapy being 

developed by Steba Biotech (New York), a company using 

laser technology for activation of a material for killing 

prostate cancer cells. 

Not to worry, assures CEO Douglas Altschuler, the laser 

energy Steba uses is extremely low-level, more like “activated 

light,” and delivered much like standard brachytherapy 

treatment of the prostate – thus a life-saver rather than 

an instrument of torture. 

Key to the strategy is the use of a photosensitizer 

which, when activated by light, occludes the blood vessels 

that feed a tumor. Close down these vessels and you kill the 

tumor, is Steba’s theory, and an alternative to directly 

attacking the tumor itself with surgery, chemotherapy or 

the use of radiation. 

While the company’s strategy is a standard phototherapeutic 

method, the key is the use of a non-standard material 

– rather than activation of a prodrug – to provide the vessel-killing 

effect. 

Steba is using a material called WST11, which it describes 

as a photosensitizer. WST11 is a derivative of natural bacteriochlorophy, 

developed in a collaborative effort between 

Steba, Negma Lerads (Paris), and the Weizmann Institute of 

Science (Rehovot, Israel). The material is licensed by Steba 

from Weizmann. 

Steba notes that the vascular-occluding effects of photodynamic 

therapy have been known for some time, and 

with the potential for treating tumors. But it says that the 

previous attempts to destroy tumors via vascular destruction 

had been less than optimal because various photosensitizers 

remained in the cells of normal tissue, causing prolonged 

toxicity. 

By contrast, WST11 clears from the body entirely in just 

30 minutes, Altschuler told MDD. 

The material, he said, is derived from “a chlorophyll that 

is generated by bacteria which grows in the dark . . . it does 

not need sun. We take it to our facility in Israel, modify it 

and stabilize it.” He said this material is “neutral, non-toxic,” 

and termed the overall approach “green biology.” 

After injection into the tumor cite, the material is activated 

by laser light. Developed in collaboration with Israeli 

laser firm Egen (Tel Aviv), the laser is extremely low-powered, 

Altschuler noted, and “is as much of a computer as a 

laser. It measures the light power within the tumor, and 

uses a feedback loop and shuts off, and reports all the 

information about the procedure.” 


The activating light is delivered by fibers inserted near the 

prostate, in much the same way as the delivery of brachytherapy, 

then removed. And the company will market the technology 

only to those already providing brachytherapy, Altschuler 

said, so that the required training will be minimal. 

When activated by the laser light, the material serves to 

occlude the blood vessels, turns them “necrotic,’ and 

leaves, under MR imaging, only “a black hole,” he said. 

Importantly, the technique exploits the difference 

between blood vessels within a cancerous tumor, and 

blood vessels within normal tissue, he noted. 

The company currently is conducting a multi-center, 

dose-ranging trial at five sites, one in Canada and four in 

Europe and the UK, with enrollment of 40 patients. It is developing 

additional sites throughout Europe for this trial and 

will follow up with a smaller dose-ranging trial in Europe. 

The next step is pursuit of a Phase II trial in the U.S. 

Altschuler said the company soon will be talking to the 

FDA to develop the protocols for this trial, and he acknowledged 

that a key challenge will be to get the agency “to 

understand what kind of trial we need to do – nothing like 

this has ever been done before.” But he said that the company 

hopes these protocols can be worked out so that the 

U.S. trial can be launched this summer. 

To date, Steba reports procedures performed on somewhat 

more than a dozen men and said it is “quite pleased 

with the early signals of efficacy.” It also reported being in 

the “early stages” of preparation to report its data. 

Altschuler said that the company is “completely, privately 

self-funded,” and able to draw on €130 million to pursue 

the development of the application for prostate cancer. 

He spoke yesterday to MDD on his way to the airport to 

talk to investors in Los Angeles, but said any potential 

funds developed from here on out are intended to be used 

for the company’s development of its next-generation 

application, the treatment of macular degeneration. 

He noted that a good bit of photodynamic therapy had 

been used for treatment of macular degeneration but that 

this approach was quickly swamped by new drug treatments, 

particular the use of Lucentis, now standard therapy. 

But he said that Lucentis treatments are too frequent 

and eventually fail. 

Steba plans to use its photodynamic therapy strategy 

in combination with drug treatment to provide equal or 

better outcomes and with fewer treatments. 

Atlschuler acknowledged he can’t predict a timeline for 

commercialization of the prostate therapy application, but 

said that the company clearly prefers a “two-to-three-year 

window,” rather than one of five to six years. 

With an already established career in device development 

and photodynamic therapies, Altschuler understated 

by saying he sees Steba’s technology as a potential winner 

– adding: “I have a nose for these things.” 






Ekos launches ‘smarter’ blood 

clot dissolution device at forum 



Ekos (Bothell, Washington) launched the EkoSonic 

Mach4e with Rapid Pulse Modulation (RPM) for the dissolution 

of vascular blood clots today at the 36th annual 

VEITHsymposium in New York. 

Last year Ekos introduced its second-generation 

EkoSonic endovascular system with RPM and this year the 

company introduced the Mach4 upgrade. 

“We continue to listen to our customers in assessing 

how we can further improve the performance and simplicity 

of operation,” said Robert Hubert, president/CEO of Ekos. 

“The Mach4 upgrade addresses both categories.” 

For performance, Hubert said Ekos has achieved even 

faster removal of arterial and venous clots (accelerating 

thrombolysis speed by up to 40%) making it even faster 

than the previous version of the device, the Mach4. 

“We’re always striving to improve the speed,” Hubert 


For simplicity, the company has eliminated user inputs, 

which can be safely automated without requiring operator 

attention, Hubert said. 

“The system is much smarter. A world-class vascular 

innovation forum like the VEITHsymposium is the ideal 

event at which to launch the Mach4e.” 

Hubert told MDD that when Ekos launched the secondgeneration 

device last year the company was already thinking 

ahead to the next upgrade. Ekos built into the hardware 

the ability to upgrade, he said. So all Ekos’ customers have 

to do, if they already have the Mach4, is upgrade to the new 

generation via an easy software download, he said. 

“In fact, their entire inventory of devices . . . it will recognize 

the new upgrade so all of their inventory automatically 

performs to the new level,” Hubert said. 

The EkoSonic is FDA-cleared for controlled and selective 

infusion of physician-specified fluids, including thrombolytic, 

into the peripheral vasculature. Ekos said the 

device is currently used to treat patients with peripheral 

arterial occlusions and deep vein thrombosis and additional 

applications are being investigated. 

So far, customer feedback has been positive, Hubert 

said. 

“We actually had a pre-launch where we had some of 

our systems go out into the market to get a feel for the 

products actual ability and, true to form, what we saw in the 

lab has been what we’re getting,” Hubert said. 

According to the company, providers can “Ekos it anywhere” 

in the periphery – veins, arteries, IVC filters and difficult-to-reach 

places such as behind valves – and the 

device exposes clot to a greater drug uptake. 

Ekos touts several other benefits of the Mach4e, including: 

thrombus of any size, shape, volume and age can be 

treated with less lab time; uses 50% to 70% less lytic drug, 

no thrombus fracture or breakage reducing the risk of distal 

embolism; no hemolysis, no damage to valves or vascular 

wall; a higher level of vessel patency, removes the 

thrombus more completely, possibly reducing the risk of 

post-thrombotic syndrome. 

“If you look at where thrombus occurs, it occurs on the 

venous side, it occurs on the arterial side, it is small, it is 

large . . . you can Ekos any size, any length on the venous 

side, on the arterial side . . . fundamentally anywhere,” 

Hubert said. “We have no limits.” 

Ekos said it is currently participating in the ATTRACT 

trial which will evaluate the long-term benefits of using 

ultrasound catheter-directed thrombolysis for removal of 

clot. 

The VEITHsymposium, now in its fourth decade, provides 

vascular surgeons, interventional radiologists, interventional 

cardiologists and other vascular specialists with 

a format to learn about what is new and important in the 

treatment of vascular disease. The five-day event in New 

York features presentations from vascular specialists with 

emphasis on the latest advances, changing concepts in 

diagnosis and management, pressing controversies and 

new techniques. 

(This story originally appeared in the Nov. 19, 2009 edition 


51 



52 

VBLOC blocks signals between 

brain and gut for weight loss 



Brain to stomach, brain to stomach, ALERT: food is on 

the way, start expanding. 

Stomach to brain (as food is consumed): not satisfied 

yet, send more food. 

This is essentially the conversation that takes place 

between a person’s brain and stomach, usually from the 

minute the nose senses food. And this communication is 

the reason that EnteroMedics (St. Paul, Minnesota) has 

developed its alternative to weight-loss surgery: a technology 

designed to slow down or even block the signals from 

the brain to the stomach and back again. 

EnteroMedics recently reported interim data from the 

VBLOC-RF2 feasibility study of its VBLOC vagal blocking 

therapy device, the Maestro. The study, taking place at two 

sites in Europe and one in Australia and including 38 

implanted subjects, is designed to evaluate the system’s 

safety and efficacy. 

Follow-up data show excess weight loss of 37.6% in 

nine patients at 18 months of VBLOC therapy, 28.1% in 17 

patients at 12 months of therapy and 17.9% in 35 patients at 

six months of therapy, according to the company. Also, no 

deaths or unanticipated adverse device events have been 

reported. 

“VBLOC therapy is designed to produce weight loss, in 

part, by controlling the feelings that lead patients to fail at 

losing weight, including hunger and a lack of feeling full,” 

said Mark Knudson, PhD, president/CEO of the company. 

“These results are an encouraging sign that significant 

weight loss, occurring over an extended period of time, can 

take place without the serious side effects and adverse 

lifestyle impact seen in other obesity procedures. 

“We continue to look forward to releasing the results of 

our randomized pivotal trial in the second half this year.” 

VBLOC therapy is a high-frequency blocking technology, 

not a stimulation therapy as used by other companies in 

the neuromodulation space, Greg Lea, the company’s senior 

VP and CFO, told Medical Device Daily. 

Lea explained that surgeons use to routinely cut the 

vagus nerves near the stomach to treat ulcers, a procedure 

known as a vagotomy. When they did this they noticed right 

away that patients lost their appetite and started to lose 

weight, Lea said. So, in 2002, based on an analysis of the 

vagus nerve’s control of food intake and processing, 

EnteroMedics was founded to develop a therapy to treat, 

primarily, obesity. 

VBLOC therapy is delivered through leads implanted 

laparoscopically in the abdomen to intermittently block 

vagal nerve trunks. High-frequency, low-energy electrical 

impulses are delivered by an implantable system to block 


the messages conveyed through the vagal nerves. If 

desired, the VBLOC delivery system can be removed if, and 

previous studies in animals have indicated that it does not 

damage or permanently affect the vagal nerves. 

Like other weight-loss procedures, the benefit of losing 

weight is complemented by an improvement in co-morbidities 

so frequently associated with obesity, such as Type 

2 diabetes and hypertension. But unlike the laparoscopic 

banding and gastric bypass procedures, the improvements 

in co-morbidities do not correspond to weight loss, Lea 

said. He said in many patients the minute the VBLOC therapy 

is applied, or soon thereafter, the patient’s hypertension 

improves, as well as their diabetic condition. 

“In our case, what we’re seeing is that those conditions 

improve prior to weight loss . . . it’s very encouraging,” he 

said. 

The company reported the co-morbidity data earlier 

this month at the J. P. Morgan conference. And it also reported 

its 18-month follow-up data showing that weight loss is 

“very consistent” with what patients experience in banding 

procedures, with a “much better” safety profile, Lea said. 

According to the data, 10 patients with diabetes showed 

a statistically significant reduction of 1.1 percentage points, 

from 8.2% at baseline to 7.1% at four weeks; and 15 patients 

with both systolic and diastolic hypertension, which was 

either untreated or controlled with drugs, showed statistically 

significant reductions of 13.9 mm Hg in systolic pressure 

and 10.7 mm Hg in diastolic pressure at four weeks. 

The improvements in blood pressure are maintained 

through six months, the company noted. 

EnteroMedics’ study outside the U.S. started out with 

38 patients enrolled, but some patients elected to drop out, 

Lea said, because the company had to offer a procedure in 

laparoscopic banding or gastric bypass if they didn’t like 

the VBLOC procedure. 

“Many of them used our procedure to jump the queue, 

getting into our study and then six months later saying ‘give 

me lap band’,” he said. “So we had some fall out, but we still 

anticipate somewhere between 20 to 25 patients in the trial.” 

In addition to the VBLOC-RF2 study, the Maestro system 

is being used in the company’s pivotal EMPOWER clinical 

trial, a randomized, prospective, double-blind, placebocontrolled 

study being conducted in the U.S. and Australia 

under an FDA Investigational Device Exemption. The trial 

was fully enrolled at 15 sites (13 in the U.S. and two in 

Australia) with 294 patients in September. 

Lea said that one-third of the 294 patients in the trial 

have the device implanted but not turned on while two 

thirds have the device turned on. The study blind – which 

remains in place for 12 months after activation of therapy in 

the experimental arm – is expected to lift in the second half 

of this year, EnteroMedics noted. 

Another company, GI Dynamics (Lexington, 

Massachusetts) also has a device designed to treat diabetes 

independently of weight loss. 




53 

In September 2008 the company reported data showing 

that patients with uncontrolled Type 2 diabetes treated 

with an EndoBarrier GI liner achieved “significant improvement” 

of glycemic control in a week as compared to a sham 

control. Most importantly, the company said, the immediate 

improvement of glycemic control was independent of 

weight loss, suggesting a direct action on the study. 

GI Dynamics’ device is designed to mimic the effects 

of gastric bypass surgery on a patient’s metabolism, also 

resulting in weight loss and remission of Type 2 diabetes 

The EndoBarrier, creates a mechanical bypass of the duodenum 

and proximal jejunum. It allows food to pass 

through the device, and allows bile and pancreatic 

enzymes to travel outside the liner, allowing bile and 

intestinal hormones to travel around the liner without 

touching the food until later in the gut. 

(This story originally appeared in the January 27, 2009, 




54 

Envoy Medical poised to alter 

hearing loss device market 



Just about anyone with hearing loss will tell you that 

hearing aids never restore natural hearing and the only 

alternative, cochlear implants, have so far failed to deliver 

on the promise of either sound clarity or being a totally 

implanted device. Both devices plague users with highpitched 

tones, amplified bodily sounds and worse. 

Envoy Medical (St. Paul, Minnesota) is poised to alter 

the hearing loss device market with a new technology. The 

company has just received FDA protocol clearance to submit 

a PMA in August for Esteem, an entirely new-concept 

hearing restoration device that Envoy claims rivals anything 

currently available. 

With 278 million people worldwide who have moderate 

to profound hearing loss, the potential for Envoy is enormous. 

“The entire audiological community will fall out of their 

chairs when they see the Esteem,” Envoy CEO Patrick 

Spearman told Medical Device Daily, adding this analogy 

about the new device, “LASIK is to vision what Esteem will 

be to hearing. We’ve spent 14 years and $105 million to get 

to where we are today.” 

Traditional hearing aid technologies rely on microphones 

for amplification. Esteem uses the body’s own 

eardrum as a natural microphone. 

A totally implanted device similar to pacemaker technology, 

Esteem has two transducers – a sensor and a driver 

that extend into the middle ear from the sound processor 

which is implanted just behind the ear. Sound waves travel 

into the ear canal and set the ear drum into motion causing 

the bones of the middle ear to vibrate. The device senses 

these movements and delivers a dose of energy to the 

cochlea, which then transmits the signals to the brain. 

A small remote control device allows users to turn the 

Esteem on or off at will, adjust volume if needed in different 

settings. Spearman said one of the biggest complaints that 

traditional hearing aid users have is that they can’t filter out 

background noise like a natural ear. So if a TV is running in 

the background or if the person is in a noisy crowded room, 

it’s difficult to hear a person speak even if they are very 

close. Esteem apparently subverts that problem. 

There are two types of hearing loss: conductive, which 

is a problem in the outer or middle ear, and sensorineural, 

which typically involves a problem with the inner ear, and 

usually is permanent. Common causes of sensorineural 

hearing loss are excessive noise and aging. 

Spearman said the Esteem would work for about 80%, 

or 24 million, of the 30 million Americans with sensorineural 

hearing impairment. 

Of data the company will submit with the PMA, 


Spearman said, “Our results are so good that when we 

apply for FDA approval, our PMA will claim that we are 

superior to hearing aids.” 

Envoy will use data from two Phase II trials of 150 people 

who each received one hearing implant. Of those, only 

three needed to be explanted due to complications. 

In addition to the clarity of sound, Spearman said 

another advantage is a battery that will last for up to nine 

years without recharging. 

“Cochlear implants were the first devices used that 

replaced a human sense,” Spearman said. “But Esteem 

brings people back to levels of hearing where they were 

before, something that cochlear implants can’t do. It’s really 

touching and this really is something that will benefit 

society in a big way.” 

In addition to the positive data to be presented from 

two Phase II trials, what’s impressive about the company 

and the potential of the device to impact the market can be 

seen in who is backing Envoy. Spearman and his family own 

about one-third of the company. Among other supporters 

and investors: 

The inventor of cochlear implants, William House, sits 

on Envoy’s board. 

Ken Dahlberg, who developed the first all-in-the-ear 

hearing aid, now known as the Miracle-Ear, is a key investor 

and sits on the board. His company, Miracle-Ear, is now 

owned by Amplifon Group (Milan, Italy), which claims to be 

the world leader in the distribution and fitting of personal 

hearing solutions. 

Billionaire Glen Taylor, who owns the Minnesota 

Timberwolves basketball team, is another big investor. 

Allen Lenzmeier, former vice chairman of Best Buy 

(Minneapolis), also has made a substantial investment. 

And, Glen Nelson, MD, former vice-chairman of 

Medtronic (Minneapolis), owns about 1% of the company. 

In addition to the heavyweight angel investors, Envoy 

raised $12.5 million in 2007, closed another $12 million 

fundraising just last month and plans to tap the market 

again this summer for up to $30 million, despite current 

market conditions. 

Spearman isn’t daunted by the idea that med-tech firms 

saw investments fall 51% from the $972 million for 74 deals 

last year to $477 million for 42 deals in the most recent 

quarter, according to Dow Jones VentureSource. 

“We have a lot of money and keep putting in money 

ourselves,” he said. “To raise $25 million to $30 million 

should be a slam-dunk. We have such a high value, it makes 

raising money easy. We believe the company can be sold, 

after FDA approval of Esteem, for over $1 billion.” 

But Spearman has no plans to sell the company. The 

goal, he said, is to go public and then create a surgical franchise. 

“It takes a skilled surgeon to implant the Esteem and 

we want to make sure they are properly trained and we 




55 

want control of it all,” he said. “There’s a steep learning 

curve. Our marketing strategy will be completely different. 

We’re not going to hospitals and doctors. We’re going to 

launch our own surgical centers and use direct-to-consumer 

advertising. If you use a hospital, the cost of surgery 

is $30 to $40 a minute. If you have your own center, it’s $6 

to $10 per minute, like a plastic surgeon.” 

Even with that reduced facility cost, the Esteem won’t 

be inexpensive. With an initial price tag of $25,000 for the 

device and surgery, Spearman said they company has no 

immediate intention to seek reimbursement from insurers. 

“Initially, there are enough people who can afford this,” 

he said. “We’re not going to be at the beck and call of the 

medical community on what we can charge. When they see 

the success, they’ll come to us. The public will sell this 

product. If a pacemaker is put in, how can you tell if it’s 

working Only the doctor can tell. With our device, the 

patient can tell if it works or not. This product is a public 

interest story and we’re going to devote tens of millions to 

advertising.” 

Eventually, the volume of sales will reduce the overall 

cost of Esteem, he said. 

Esteem already is approved in Germany, France, Italy, 

Belgium, Switzerland, Spain, India and Iran, but the company 

is currently focused primarily on the U.S. launch, 

Spearman said. 

(This story originally appeared in the April 21, 2009, edition 




56 

Fluid-warming Angel found on 

battlefields launched commercially 



Sometimes the most exquisite medical solutions aren’t 

necessarily the most complex. And more often than is 

widely known, effective medical technologies emerge on 

battlefields or from emergency first responders. Such is the 

case with Estill Medical Technologies’ (Dallas) Thermal 

Angel Blood and IV Fluid Infusion Warmer. 

It’s a small, simple, inexpensive ($99) battery-operated 

solution that keep patients normothermic. 

A decade ago, two registered nurses produced a study 

that revealed the vast benefits of avoiding intraoperative 

hypothermia, which can cause a number of complications 

ranging from reduced resistance to wound infection to 

increased loss of blood. They deduced that these types of 

complications can cost $2,500 to $7,000 per patient (AANA 

Journal, April 1999). 

“The idea for the Thermal Angel came from a fireman,” 

Jay Lopez, Estill president told Medical Device Daily. “He 

knew there were significant issues when responding to 

accident scenes where they didn’t have a way to warm fluids 

in the field. In the past, EM guys would put the IV bag in 

an armpit or on the dash of vehicle and turn on a car 

heater.” 

From that emerged the Thermal Angel, which for the 

last decade has been sold exclusively to the military for use 

on the front lines of war and anywhere that AC power was 

unavailable. Estill has just recently ramped up manufacturing 

capacity for a full commercial launch based on demand 

from military personnel who have come back home to regular 

medical duties only to find older, larger, clunkier fluid 

warming systems and wondered why the Thermal Angel 

was unavailable for civilian use. 

Typical fluid warmers heat either plastic tubing sets or 

plastic cassettes using circulating water baths or warming 

plates. They need to be plugged into an AC outlet with tubing 

running from the wall to the patient. The nine-ounce 

Thermal Angel is inserted below standard IV tubing, coming 

from the bag and before the extension set leading to 

the infusion site. It takes 30 seconds to set up and warms in 

about 45 seconds. 

“It was designed to be as close to the patient’s infusion 

site as possible,” Lopez said. “It’s a single-use device that 

you can hook up at any point in the entire continuum of 

care and you can leave it there for three days of constant 

use.” 

What’s also different about this fluid warming device 

compared with conventional fluid warmers is that the 

Thermal Angel directly measures the temperature of the 

fluid delivered to the patient and, based on the temperature, 

control software modifies the output of the heater flex 


circuit nearly 5,000 times per second to attain normothermic 

temperature. 

“As caregivers change fluid rates or if there’s a kink in 

the line, anything, it reads the temperature and immediately 

responds,” he said. “Older-style machines have to build 

up heat in a water bath and can’t react quickly. This is 

designed to be extremely light and quick to respond.” 

Lopez said one of the reasons for the recent decision to 

bring Thermal Angel to the mainstream is the H1N1 pandemic. 

Because certain patients can be at greater risk for 

hypothermia due to dehydration, those who receive reviving 

IV fluids can benefit from the addition of this temperature-stabilizing 

device. 

In addition to emergency use, Lopez said that some 

healthcare providers are starting to use the device in elective 

dental and plastic surgeries for patient comfort since 

operating rooms are typically cool and patients often wake 

up shivering. 

“Until now we have focused primarily on serving the 

U.S. military,” he said. “We have been completely overwhelmed 

from all sectors of the U.S. government and chose 

to keep a low profile because we didn’t have the capacity. 

But last year we worked on production capacity and tripled 

our output. We’ve got a strong steady supply and now 

we’ve been able to meet the needs of the government and 

we’re starting to let the commercial market have it. We 

don’t do any sales and marketing, nor do we have any sales 

people. Guys coming back from duty in the military have 

spread the word.” 

(This story originally appeared in the Nov. 2, 2009 edition 





Exmovere Chariot could make 

moving easier for amputees 

By OMAR FORD 


Amputees and others who have difficulty standing may 

be able to move around a lot easier thanks to a new prototype 

that was unveiled late last week by Exmovere 

(McLean, Virginia). 

The company has developed a device called the 

Exomovere Chariot, a “wearable,” self-balancing vehicle. 

The Chariot mostly resembles the bottom of a showbot, 

robot suits that are used in trade show and marketing venues. 

Exmovere said that unlike other self-balancing vehicles, 

the Exmovere Chariot is controlled by subtle movements 

of the lower torso and hips. Sensors inside the 

cocoon-like shell of the vehicle predict the intended motion 

of the wearer. The Chariot requires no manual dexterity, 

minimal physical effort and allows wearers to closely 

approach and reach objects. 

The upright form of the Chariot allows its wearer to 

make direct eye contact with others. The Chariot is battery 

powered and can travel up to 12 miles per hour. 

“The Chariot is a concept vehicle,” Exmovere Chairman 

David Bychkov told Medical Device Daily. “It’s not a product 

yet. I imagine that at some point when our research is complete 

with the Chariot that there will be some type of action 

requesting FDA approval.” 

BychKov said the bread and butter for the Chariot 

would be for those who work in mail houses and the military. 

“So far we’ve been getting enormously positive feedback 

from the Pentagon,” he said. “We’ll need to go a little 

further on the R&D trail to meet their needs but this is definitely 

going to lead to some great possibilities.” 

Production versions of the Chariot will integrate 

Exmovere’s proprietary vital sign sensors, environmental 

and ground clearance sensors, wireless and cellular connectivity, 

a smaller form factor and unique options for military 

and law enforcement customers. Exmovere will also 

develop a feature of the Chariot that can switch the wearer 

from upright to seated position. Exmovere seeks to partner 

with an automotive manufacturer to eventually launch a 

performance-oriented Chariot. 

With its upright form, the Chariot lets wearers make 

direct eye contact with other people, as if they were standing. 

The battery powered concept vehicle, has been 

unveiled in demonstrations at Exmovere’s headquarters. 

They are also designing a version that will allow the wearer 

to move from an upright to seated position, letting 

them ‘sit down’ between journeys, while still wearing the 

device. 

When asked how the Chariot works, Bychkov says it’s 

simple: “Just like a pair of pants. How do your pair of pants 

know where you’re going to go when you walk . . . that’s 

how simple the Chariot is.” 

The only requirement is that the person would have 

some ability to move their lower torso. A slight movement 

is all that’s needed to get the Chariot going in the needed 

direction. 

The company has been working on self-balancing tech 

such as the Chariot for 14 months. Plans also call for the 

vehicle to be reconfigured to more easily deal with an outdoor 

terrain. This modification was noted after the company 

received feedback that this would be an extraordinary 

feature to add to the Chariot. 

“The Chariot represents an exciting path for our company. 

Whereas our team was originally focused on designing 

sensor products that monitored signs of life, the 

57 



58 


Chariot’s sensors are designed to make life more livable. 

We especially hope that the Chariot will offer dignity, 

strength and increased mobility to those who were wounded 

serving our country,” Bychkov said. 

To date the Chariot’s competition in the self-balancing 

devices market is the already existing Segway PT, a twowheeled, 

electric vehicle. It is produced by Segway 

(Bedford, New Hampshire). The Segway was first unveiled 

nearly eight years ago, but first produced in 2002. 

Exmovere is a biomedical engineering company that 

specializes in emotion sensing applications for healthcare, 

homeland security and mobility. 

(This story originally appeared in April 14, 2009, edition 





EndoBarrier’s new Restrictor 

spurs even more weight loss 

By OMAR FORD 


GI Dynamics (Lexington, Massachusetts) said it has 

once again struck gold in the fight for weight loss, with a 

new component to its EndoBarrier device. 

The company reported that patients who have been fitted 

with the EndoBarrier Gastrointestinal Liner are seeing 

even more excess weight being shed with the addition of 

the new EndoBarrier Flow Restrictor to the device. 

“With the EndoBarrier just used by itself on a patient, 

we see about 20% excess weight loss at six months,” 

Jonathan Hartmann, a spokesman for GI Dynamics told 

Medical Device Daily from the floors of the International 

Federation for the Surgery of Obesity and Metabolic 

Disorders annual meeting in Paris. “When we combine the 

flow restrictor with the EndoBarrier we see nearly double 

the weight loss.” 

Hartmann and representatives from GI Dynamics are 

set to present results of a clinical study regarding the effectiveness 

of EndoBarrier with Flow Restrictor at the conference, 

tommorrow. 

The study, which was previously highlighted in June at 

the 26th annual meeting of the American Society for 

Metabolic and Bariatric Surgery (ASMBS; Gainsville 

Florida), demonstrated the substantially enhanced weight 

loss benefits of combining the company’s EndoBarrier 

Gastrointestinal Liner with a new EndoBarrier Flow 

Restrictor. 

In this initial, single-center study of 10 morbidly obese 

people (body mass index between 35.8 and 47.8), participants 

achieved the following results over a twelve-week 

period during which the device was implanted (median values 

reported): 

• Percent Excess Weight Loss (%EWL): 39.6% 

• Weight Loss: 36.7 pounds (16.7 kilograms) 

• Percent Total Body Weight Loss (%TBWL): 15.4%. 

All 10 patients completed the 12-week study. The most 

common side effects included mild to moderate abdominal 

pain, nausea and vomiting. 

“We have had significant clinical experience with the 

EndoBarrier at our obesity management center, and even 

when assessed relative to invasive and other noninvasive 

procedures, we believe the EndoBarrier platform represents 

a much needed new approach to reducing weight and 

improving blood sugar control in obese patients and 

patients at risk for serious metabolic disease,” said Manoel 

Galvao Neto, MD, a lead investigator for the study.” 

“In particular, we are excited about the new data 

emerging from our ongoing clinical study in people living 

with Type 2 diabetes and the notable impact EndoBarrier 

59 

appears to have on blood sugar control. We look forward to 

sharing these data later this year upon completion of the 

trial,” he said. 

The EndoBarrier Flow Restrictor provides an adjustable 

restriction at the outlet of the stomach and is designed to 

delay gastric emptying, an additional mechanism which 

adds to the therapeutic effects of the liner. 

The EndoBarrier GI Liner, by itself creates a physical 

barrier that lines the intestine to keep food from coming in 

contact with the intestinal wall. Physicians believe this may 

alter the activation of hormonal signals that originate in the 

intestine, and may mimic the effects of a Roux-en-Y gastric 

bypass procedure. 

However, the EndoBarrier procedure is done without 

the risks associated with highly invasive surgical procedures. 

The EndoBarrier is placed and removed endoscopically 

(via the mouth) without the need for surgical intervention 

or alteration of the patient’s anatomy. 

“It’s the same device, but the flow restrictor has a 

diaphragm in the center of it with a 4 mm hole in its center,” 

Hartmann said. 

So far, clinical trials involving more than 250 patients 

have demonstrated the dramatic weight loss and diabetes 

improvement achieved with the EndoBarrier 

Gastrointestinal Liner. 

These latest data suggest that the combination of the 

EndoBarrier Gastrointestinal Liner with the EndoBarrier 

Flow Restrictor could enhance the effectiveness of the liner 

by nearly doubling the amount of weight-loss achieved by 

using the liner alone. The clinical data is consistent with 

previously reported pre-clinical data from the company 

assessing the combination of devices in a porcine model. 



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60 

GI Dynamics’ EndoBarrier 

gets favorable study results 

By OMAR FORD 


GI Dynamics (Lexington, Massachusetts) attempts for 

regulatory approval for its EndoBarrier Gastrointestinal 

Liner received a much-needed boost with the release 

results of a European weightloss study targeting the 

device. 

The device, which is the flagship product of the company, 

was evaluated for its safety and efficacy for pre-surgical 

weight loss treatment, along with a positive effect on 

glucose homeostasis in morbidly obese patients with Type 

2 diabetes mellitus. 

Study data were published in the Annals of Surgery. 

“The company is very pleased with these results,” Stu 

Randale, GI Dynamics, CEO told Medical Device Daily. “The 

results seem to coincide with other trials that we have had 

in South America. This was the first European clinical 

weight loss study conducted with the EndoBarrier, and 

since then the EndoBarrier has been successfully implanted 

in more than 250 patients. As GI Dynamics has expanded 

the clinical development program for EndoBarrier in 

patients with obesity and Type 2 diabetes, we have continued 

to see impressive results.” 

In the most recent multi-center, randomized clinical 

trial, 41 patients were enrolled and 37 patients were treated. 

Twenty-six patients received the EndoBarrier and 11 were in 

the diet control group. The EndoBarrier was implanted for 

12 weeks. Three patients kept the device implanted for 24 

weeks. Patients in both the EndoBarrier and diet control 

groups followed the same diet during the study period. 

Starting average weight for these two groups was similar 

with 142.5 kg (314.2 lbs) for EndoBarrier patients versus 

137.5 kg (303.2 lbs) for control group patients, and body 

mass index (BMI) of 48.9 vs. 49.2, respectively. 

Mean excess weight loss (EWL) achieved after 12 weeks 

was 19.0 % for EndoBarrier patients versus 6.9 % for control 

patients (p


Broad-scope test aims to 

catch cancer before it starts 



There are a number of good cancer tests designed to 

catch the disease as soon as it shows up, but one company 

believes it has found a way to detect signs of whole-body 

cancers long before the disease is even present. 

GlycoMeds (Phoenix) says its Cancer Test is a broad-scope 

test that detects conditions within the body that allow cancer 

cell growth prior to cancer cells being active. 

GlycoMeds’ Cancer Test employs a process that produces 

consistent measurements of the chemical composition 

of a person’s saliva, the company says. It is an at-home 

test designed to alert the user to the presence of conditions 

within their body that are conducive to the growth of 74% 

of all cancers, including breast, lung, kidney, colon, liver, 

bone and brain cancer. The kit does not measure pH, the 

company noted. 

Unlike certain other at-home diagnostics, the results of 

this test are not black-and-white, Roger Brown, PhD, CEO of 

GlycoMeds, told Medical Device Daily. 

“With our test it’s a gray-scale test, we don’t tell you 

that you have cancer or that you don’t have cancer, we just 

give you the likelihood,” he said. 

The test is not keyed for any specific type of cancer 

either, Brown said, but is more sensitive to cancers that 

affect the whole body, such as lung cancer. Not all cancers 

affect the whole body, he noted. 

With lung cancer, for example, the patient’s entire body 

is affected as their pH levels drop and their system slowly 

goes down. It can take years before the system will degrade 

to the point where the cancer will be detectable clinically, 

Brown said. While acknowledging that there are other tests 

that can catch cancer as soon as it shows up, he said doctors 

don’t currently have a decent way to detect ahead of 

time the patient’s likelihood of getting cancer. 

According to the company, the GlycoMeds Cancer Test 

works because most cancer cells live in a narrow pH range 

within the body. As long as the body’s system pH is outside 

that range, most cancer cells cannot survive. 

The GlycoMeds test measures the changes in a person’s 

fluidic system once a day for three days, averages 

those changes, and compares them to the changes a 

healthy person’s fluidic system would undergo. The measurement 

is then equated to a condition level on a scale of 0 

to 7, where 0 is healthy – no conditions conducive to the 

growth of whole-body cancer cells – and 7 has a prognosis 

of death. 

If the number reveals an active possibility of cancer 

(levels 4, 5 or 6), the person taking the test is advised to 

make an appointment with his or her doctor for further 

evaluation. But if the test shows cancer is not imminent 

61 

(levels 1, 2 or 3), the person taking the test can take corrective 

action to bring his or her system back to normal, thus 

inhibiting cancer cell growth. 

“If you’re a level 4 or a level 5 it doesn’t say ‘I have cancer’ 

but it says ‘I better go to the doctor’,” Brown said. 

“Essentially the kit is just saying ‘maybe you ought to have 

an extra checkup this year.” 

Brown said the test instructs the consumer to take the 

saliva test three mornings in a row and average the results 

together because a lot of people have never taken a saliva 

test and the first time they take it they may drop it on the 

floor or accidentally do something else that could affect its 

accuracy. Hopefully, he said, by taking the average of three 

days’ worth of results, the test will produce a reasonably 

accurate result. 

“I wanted to keep it as simple as possible, but also as 

accurate as possible,” Brown said. 

If the test is being administered by a healthcare professional, 

Brown said supplemental instructions included in 

the kit say it is fine to use the results of just one sample 

because “they usually know what they’re doing.” 

The company said it is looking for a partner to license 

and market the Cancer Test Kit, which has not yet been presented 

to the FDA for comment. 

Brown said the Cancer Test has been in development 

since 2004. He said there has been very little research done 

on the causes of cancer vs. system condition. In 2004, however, 

there was a study done in which researchers linked a 

low pH system to cell conduciveness to viral cancers. The 

lower the system pH, the more susceptible the cells are to 

being turned into cancer cells, Brown noted. 

“I think it’s important from the point of view that a lot 

of people would like to know whether they’re at risk more 

than normal for cancer or not,” Brown said. He compared 

the Cancer Test to a popular at-home HIV test. “From the 

research we’ve done, there are more people that are concerned 

about whether or not they have cancer than there 

are people who want to know if they have AIDS or HIV.” 

In addition to the at-home HIV test that Brown mentioned, 

the Cancer Test joins a whole host of diagnostics 

that are being sold directly to consumers now, which are 

designed to tell people what their risk level is of developing 

a particular disease. 





62 

Sponge-like polymeric discs 

offer new cancer strategy 

By DON LONG 


What’s better — to invent or to innovate 

Invention, of course, can get you into the history books, 

though inventors often miss out on the value of the resultant 

products. 

Innovation, by contrast, is considerably easier because 

you can use available technologies – and get more quickly 

to market – and to the clinic, importantly, in the case of 

medicine. 

Taking available technologies and putting them 

together in a sophisticated new way is the strategy being 

employed by David Mooney, PhD, and a group of bioengineers 

and medical collaborators at Harvard University 

(Cambridge, Massachusetts). 

They are using polymers commonly employed in 

device technology, combining these with standard 

approved drugs, to develop a new pathway for the delivery 

of vaccines and, they hope, further out, for reengineering 

the human immune system against diseases. 

In his lab, Mooney and his team used biodegradable 

polymers similar to those used in sutures and other materials 

to create small discs (about 8.5 mm across) that are 

implanted beneath the skin – similar to contraceptives that 

are implanted in a woman’s arm. 

The implants are about 90% air and somewhat comparable 

to a sponge, he told Medical Device Daily. The discs 

incorporate drugs and antigens which interact with the cellular 

physiology of the body to attack cells that may develop 

into tumors. 

Implanted in rats for this study, the strategy destroyed 

an aggressive form of melanoma – a form that would kill 

the rodents in 25 days, the researchers said – in 90% of the 

rats. And they said this approach could turn out to offer the 

most effective strategy for delivering a cancer vaccines. 

“We purposely took things [for the study] that all had an 

established safety record in humans,” Mooney told MDD, 

rather than inventing. “We took some standard pieces and 

put them together.” 

He said also that the system can be used with drugs 

already in general use and that the primary challenge in the 

method is “to get the drug to recognize the type of cancer.” 

The approach of this research is to manipulate the cells 

already in the body as opposed to a method that Mooney 

said has been attempted without great success. 

Previous work on cancer vaccines, he said, has focused 

on removing immune cells from the body and reprogramming 

them to attack malignant tissues. The altered cells are 

then re-injected into the body. 

Theoretically and according to the evidence supporting 

this approach, he said, this should work. But he noted 


that the work utilizing this technique has shown that more 

than 90% of the re-injected cells die before having any 

effect. 

By manipulating the cells already within the body, as in 

this study, the strategy also may be usable for boosting the 

body’s immune system to fight off other diseases, Mooney 

said. And the focus of the team’s research is more on a preventive 

approach rather than on exploring the therapeutic 

pathway versus diseases already attacking the body. 

“We’ve been very interested for a number of years in 

cell therapies in the context of regeneration,” he said. “But 

we began to think, a couple of years ago, that it would be 

greatly preferable if we could control cells that already 

existed within the bodies instead of transplanting cells.” 

The transplantation process, he called “awkward and 

expensive,” and that it is “much nicer do all the manipulation 

in the body.” 

Further explaining the approach, Mooney said that the 

drugs and cytokines bioengineered into the discs act to 

attract “immune-system messengers” called dendritic cells. 

The dendritic cells then report to nearby lymph nodes, 

“where they activate the immune system’s T cells to hunt 

down and kill tumor cells throughout the body.” 

In essence, he said that the discs are used to “mimic the 

danger . . . that activate these cells. They know they’ve seen 

something foreign so that travel to the lymph nodes . . . and 

go find the tumor” and destroy it. 

While Mooney’s group focuses on creating the discs, he 

emphasized the important collaboration with medical school 

researchers at Harvard, citing especially the work of Glenn 

Dranoff MD, of the Dana-Farber Cancer Institute (Boston). 

Researchers there, he said, developed some of the cancer 

vaccines in clinical trials . . . and provided a tremendous 

amount of assistance in term of the immunological aspect.” 

The next steps for this research 

The collaborators will continue to study this approach, 

Mooney said, and, in the meantime, a parent is being 

sought and the method has been licensed to InCytu 

(Lincoln, Rhode Island), which he described as “a small startup 

company.” 

As with all of the basic research approach, Mooney told 

MDD it is “very hard to predict” when the method will reach 

general use for patients. 

But he said that the attempt was to ‘take an approach 

where that, hopefully, would not be too long. All the components 

of this system are routinely used in patients today, 

and all the components have safety profiles that are very 

good.” 

Based on “the way we combine things,” Mooney said, 

the hope is to move the method “quickly to the clinic.” 

Mooney and his Harvard colleagues describe the 

research in the current issue of the journal Nature 

Materials. 






HealthPartners integrates X-rays, 

radiology reports into EHRs 


Medical Device Daily Staff Report 

While some organizations are still struggling to implement 

electronic health records (EHR) or even computerized 

physician order entry (CPOE) HealthPartners (St. Paul, 

Minnesota) is way ahead of the curve, now one of the first 

organizations in the country to integrate electronic X-rays, 

MRIs, CT scans and radiology reports into patients’ EHRs. 

In addition to reducing radiology report turnaround 

times from two days to four hours, the organization’s overall 

efforts to eliminate paper and film and evolve into a 

complete electronic reporting environment have yielded an 

estimated $14 million in savings for the health plan since 

2007. But that’s a drop in the bucket compared to the 

resulting everyday efficiencies and patient satisfaction. 

“We’ve had a radiology information system – PACS (picture 

archiving and communication system) – in place for 

quite some time that was standalone and separate from our 

EHR,” Kim LaReau, VP and chief information officer at 

HealthPartners’ Regions Hospital told Medical Device 

Daily. “In 2006 we put the radiology report in the EHR with 

a link to images. The final phase was replacing the radiology 

information system and looking at whether or not there 

was value in having an integrated system. We chose to 

move forward with Radiant Radiology Information System 

from Epic (Verona, Wisconsin). As part of that process, we 

looked at what efficiencies and economies we could get.” 

Although LaReau works at Regions, this step to digitize 

radiology records is part of a massive ongoing effort by 

HealthPartners, which is both an insurance plan and a group 

of healthcare facilities, including Regions and 25 clinics. 

The time savings produced by integrating X-rays and 

radiology reports into EHRs is especially significant given 

the fact that HealthPartners Clinics and Regions perform 

about 34,000 radiology exams every month. 

Part of the solution was to also install, PowerScribe, a 

web-based speech recognition reporting solution from 

Nuance Healthcare (Burlington, Massachusetts) that 

eliminates the need for transcription, producing a savings 

of $130,000 per year on expenses to transcribe radiologists 

reports. 

LaReau explained that radiology services were still 

very paper-oriented. A piece of paper flowed through the 

department and that’s what drove the workflow for a radiology 

image. 

“We wanted to eliminate the paper process,” she said. 

“We also looked at the radiologists; they had a need to look 

at the clinical record, to be able to work off a radiology 

work list and to dictate and transcribe.” 

The process to move HealthPartners wholly from paper 

to screen started in 1997. The big EHR rollout came in 2003. 

63 

CPOE was implemented in 2006. 

But the clinics didn’t have PACS and that was implemented 

in 2008, bringing all parts of the organization into 

one central system. 

“We’ve been in the process of optimization since then,” 

she said. 

Although every HealthPartners location still does not 

have every element of all of the systems implemented, the 

process is moving forward. 

“Whenever you have to connect disparate technologies 

it’s always a challenge in getting them to work appropriately,” 

she said. “It’s easy to have multiple versions of the 

truth out there when sending information back and forth.” 

To make the connection between all of the different 

facilities, a software program was created from scratch, 

built by a vendor. 

Other challenges involved changing the workflow 

within departments. 

“Technologists and radiologists were learning a new 

work flow; it was a big cultural challenge that involved lots 

of training. People were very involved in the development 

of the new workflow and design sessions,” she said. 

And when it came time to go live, the IT department 

provided what LaReau calls “at-the-elbow support 24/7. We 

also ran a large command center to take challenges and 

questions by phone. Certain people get in the groove fast, 

but for others it took months.” 

Now, instead of being cued to read a film or act on an 

order by paper, the prompts come electronically. 

“An order is placed and they go into cues,” she said. 

“Technologists look at those and they are prioritized 

depending on the urgency of exams. They constantly monitor 

those cues. Once an exam is completed it goes to a 

radiologist’s cue. As they pull an item off their PACS read 

list, it simultaneously launches the EHR for them. It also 

pulls up images and then they hit the button for dictation. 

At that point they can send their report to a transcriptionist 

or they can self-edit and complete the document. It also 

files a copy in medical record.” 

The team at Regions affectionally calls these multifunctional 

radiology workstations “Star Wars.” 

She said that having access to imaging reports sooner 

has been a “patient satisfier” and has allowed the organization 

to handle more patients. 

They’ve also eliminated the cost of film storage – a 

$300,000 per year savings. 

“The health plan recently implemented decision support 

for diagnostic imaging so volume levels have been 

greatly impacted by high-tech imaging,” she said. “If you 

look at national statistics on things such as MRI, volumes 

for MRIs have exploded. The question is, are all of them 

necessary The American College of Radiology has developed 

guidelines on necessity for images. So decision support 

was built into the system. Based on that, our volumes 

of MRIs have decreased.” 



64 


LaReau concluded by saying all of these advances at 

HealthPartners fit with healthcare reform. 

“It’s about having the right information on hand. If a 

patient shows up in the ER, you know their medications, 

problems, history, and you don’t have to start from 

scratch,” she said. “This just ensures that whole continuum 

of care by following the patients throughout an integrated 

system.” 

She estimates the radiology project cost $1 million. 

The organization is now simultaneously focusing on 

medical device integration directly into the EHRs. 

“What we’re trying to do is to reduce the onus on the 

clinician to have to enter information into the EHR,” she 

said. 






Study finds TRUE2go system 

easy, convenient for patients 



Good things sometimes do come in small packages – a 

point that Home Diagnostics (Fort Lauderdale, Florida) 

recently proved with the results of a clinical performance 

study of its TRUE2go blood glucose monitoring system. 

According to the company, the device is the world’s smallest 

blood glucose meter. 

The study, published in the October issue of the journal 

Diabetes Technology & Therapeutics, demonstrated the 

accuracy and precision of the True2go system and found 

that it was both easy and convenient to use by patients, the 

company said. 

Sabrina Rios, a Home Diagnostics spokeswoman, told 

Medical Device Daily that the TRUE2go is convenient for 

diabetes patients to use because of its size. The device is 

less than two inches long and about an inch and a half wide 

– just a little bigger than a quarter – and screws on top of a 

vial of test strips, Rios said. She said diabetes customers 

say they like the monitor because it is “really easy to carry 

in their purse or pocket.” The device is especially convenient 

for athletes with diabetes, she said. 

The TRUE2go monitor also works quickly, Rios noted, 

producing results in about four seconds or less. The system 

received FDA clearance last year (Medical Device Daily, Aug. 

22, 2008). 

According to the company, the purpose of the TRUE2go 

study was to test the accuracy and precision of the 

TRUE2go system and to evaluate whether lay people could 

use the system as easily as healthcare professionals. The 

study was also designed to assess lay users’ understanding 

of and compliance with the TRUE2go system’s instructions 

for use and to evaluate users’ satisfaction with the test system, 

Home Diagnostics said. 

“This study is significant in that it clearly proves that 

True2go is a system designed with user convenience in 

mind and instructions and features that make it easy for 

people living with diabetes to consistently and accurately 

self-monitor their blood glucose levels,” said Joe Capper, 

president/CEO of Home Diagnostics. “As one of the best 

predictors of good glycemic control and overall management 

of diabetes, self monitoring is a critical element of living 

well with diabetes.” 

Rios also pointed out another advantage to the 

TRUE2go system – cost. The system retails, on average, for 

$9.99 for the meter with 10 test strips included. The 

TRUEtest strips, which work with the TRUE2go monitor, 

retail for about 70 cents a strip and overall people using the 

system can save about $400 a year on their diabetes testing 

supplies, she said. 

“This study proves that the TRUE2go and meters like 

ours . . . tend to be a lot less expensive than the national 

brands but is as accurate,” Rios said. 

Home Diagnostics said that as the number of people 

with diabetes continues to grow around the world, it is 

increasingly important to minimize the complications of 

diabetes by encouraging the achievement and maintenance 

of glycemic control. To help people with diabetes 

control their blood glucose levels, manufacturers need to 

develop products that are simple, easy to use and accurate, 

the company said. The TRUE2go is a no-coding meter that 

requires a small 0.5 microliter of blood. 

Mark Kipnes, MD, Hal Joseph, Harry Morris, Jason 

Manko, and Douglas Bell, PhD, authored the study. The 

study found that 100% of glucose test results fell within ISOrecommended 

limits for glucose concentrations ranging 

from 24 mg/dl to 549 mg/dl. 

Because of its convenience, Home Diagnostics says 

that its TRUE2go system could improve compliance of testing 

for people with diabetes. 

(This story originally appeared in the Oct. 23, 2009 edition 


65 



66 

Trials to start for ImThera’s 

neurostimulator device for OSA 



A new player in the fast-emerging field of neurostimulation 

has completed development and is about to start 

human trials of its Targeted Hypoglossal Neurostimulation 

(THN) system for obstructive sleep apnea (OSA), a condition 

which causes snoring but, more importantly, can lead to 

health complications ranging from heart disease to stroke. 

ImThera Medical’s (San Diego) system provides a surgical 

option for patients who cannot or will not comply with 

continuous positive airway pressure (CPAP), the established 

therapy for OSA. It’s estimated that half of the 800,000 

patients diagnosed with OSA in the U.S. don’t use CPAP, which 

requires the user to sleep with a face mask that delivers airflow. 

“There are two types of apnea and obstructive affects 

95% of these patients. The reasons are not fully understood, 

but we know the tongue just loses muscle tone like our 

limbs relax when we sleep,” Marcelo Lima, chairman/president/CEO 

of ImThera told Medical Device Daily. “Our target 

population is the non-compliant CPAP patient, which is 50% 

of the people who have OSA and it’s costing the U.S. economy 

$20 billion to $25 billion a year because of the complications 

of OSA. We hope to become the therapy of choice, 

although I think people should try CPAP first.” 

The new product, called the aura6000, will be unveiled 

Monday at the American Academy of Otolaryngology-Head 

and Neck Surgery (Alexandria, Virginia) annual meeting in 

San Diego. 

Neurostimulation is a trendy approach these days to 

treat a variety of conditions because it offers a new level of 

efficacy coupled with low rates of complications and side 

effects compared with drugs and surgery to treat the same 

ailments. In fact, neurostimulation as a sector has been 

growing at an average rate of 16% per year since 2007 and 

a study by Scientia Advisors (Cambridge, Massachusetts) 

projects growth rates of 14% to 23% for certain technologies 

through 2012. This melding of neurobiology and a medical 

device is typically reversible too. 

ImThera’s aura6000 delivers neurostimulation to the 

hypoglossal nerve to control certain muscles of the tongue. 

Using a multi-contact electrode and a programmable 

implantable pulse generator, the system delivers muscle 

tone to key tongue muscles to prevent the tongue from collapsing 

into the upper airway. 

External components include a patient’s controller/charger 

and a physician’s notebook PC which includes the aura6000 

Clinical Manager THN Sleep Therapy physician software. 

Targeting multiple tongue muscles to deliver therapy; it operates 

in open loop, continuous mode during sleep. 

The system, invented by ImThera Medical just three 


years ago, is designed to increase airway flow, permitting 

normal and restful sleep for OSA patients. Animal trials were 

conducted in 2008 and now prototypes are ready for a 12- 

patient clinical trial in Europe. ImThera has received Ethics 

Committee clearance to begin human clinical trials in 

Belgium and has received ISO 13485 certification of its quality 

system as a prerequisite for the future CE mark application 

for European commercialization of medical products. Results 

from this pilot study are set to be published during 1Q10. 

“The surgery takes approximately 25 to 45 minutes,” 

Lima said. “The surgeon places an electrode that self wraps 

around hypoglossal nerve at base of neck with an incision 

that’s 3 cm to 5 cm. A 3 cm to 4 cm incision is also made in 

the chest and the surgeon guides a canula up the chest, 

under skin to the base of the neck to drop the lead wire and 

connects it to IPG and places over pectoral muscle. It’s one 

of the smallest IPGs in the world at 11.5 cubic cm in volume.” 

The IPG he refers to is a multi-contact electrode and a 

programmable implantable pulse generator (IPG). About a 

week after the device is implanted, a pulmonary physician 

or sleep lab technician will turn on the device and program 

it to deliver tongue muscle tone that opens up the airway. 

During the trial, investigators will validate efficacy with 

nasal endoscopy while the patient is awake along with a 

follow-up in a sleep lab to evaluate how it’s working. 

“The patient experience is much like any other neurostimulation 

device . . . a tiny tingling sensation,” he said, 

adding that a couple of patients were already implanted 

with the device outside of the U.S. as part of engineering 

experiments. “So we know it works.” 

The trial in Europe, at the Catholic University of Louvain 

(Belgium), will gather safety and efficacy data and set the 

stage for submission to the FDA in the U.S., which Lima said 

will be occur during the first half of 2010. 

Lima said ImThera Medical, a private company, is sufficiently 

funded with a $5 million investment that will take 

the company through 2010. With no partners, the new firm 

plans to produce its own devices, build a sales force in the 

U.S. and look for dealers and distributors in Europe. 

“Our mission is to help moderate-to-severe OSA 

patients enjoy better lives while substantially reducing 

healthcare costs related to serious complications associated 

with OSA,” Lima said. 

In addition to heart disease and stroke, other potential 

complications of OSA include abnormal heart rhythm, 

excessive carbon dioxide levels in the blood, high blood 

pressure and sleep deprivation. A person with OSA basically 

stops breathing (apnea) for periods throughout the 

night. Resulting symptoms can include: abnormal daytime 

sleepiness, awakening unrefreshed, depression, lethargy, 

memory difficulties, morning headaches, personality 

changes, poor concentration and overall restless sleep 

which is riff with loud snoring. 






ExAblate uses ultrasound as 

an aid in cutting cancer pain 

By ROB KIMBALL 


Of the many devastating side effects of metastatic cancer, 

bone pain seems the most common. Almost all patients 

with metastatic prostate cancer have skeletal metastases 

and 90% of patients with progressive breast cancer develop 

these painful and debilitating lesions. 

Current pain treatments consist of systemic therapy 

(analgesics, chemotherapy, hormonal therapy and bisphosphonates) 

and local treatments (radiation, surgery and 

more recently, radio frequency ablation). 

One company is taking on the challenge of alleviating 

the pain, and the positive results are becoming evident in 

studies. InSightec (Tirat Carmel, Israel) reported that new 

publications show that magnetic resonance-guided 

focused ultrasound (MRgFUS) with the ExAblate system has 

the potential to be an effective noninvasive pain-relieving 

treatment for tumors that have spread to the bones (bone 

metastases). 

The results of a 31-patient study appear in the Nov. 11 

online issue of Annals of Surgical Oncology, while data 

from an 11-patient subgroup analysis of that study were 

published separately in the October issue of Radiology. 

“We believe these early results provide substantial 

rational for our ongoing pivotal study,” Nadir Alikacem, 

InSightec’s VP of global regulatory affairs/chief regulatory 

officer, told Medical Device Daily. 

“These patients are in the final stages of cancer and we 

believe it’s vital to maintain the quality of their lives without 

the side effects associated with radiation and analgesics,” 

he said. “Bone metastases are the leading cause of 

cancer pain and we believe that ExAblate may provide 

these patients a non-invasive, radiation free treatment.” 

Alikacem added: “Our goal is not to cure their cancer, 

but to help them live out the rest of their lives without suffering 

from their bone pain.” 

During the ExAblate treatment, the physician uses MRI 

with registered CT images to visualize the patient’s anatomy 

and then aims focused ultrasound waves at the tumor 

to relieve the pain. The MRI allows the physician to monitor 

and continuously adjust the treatment in real time. The 

patient is consciously sedated to alleviate pain and minimize 

motion. 

The focused ultrasound waves are focused down onto 

a small area of the painful bone. This causes the bone surface 

to heat up and destroys the tissue. The focused ultrasound 

is then targeted to another area next to the treated 

location and this new area is treated. 

The process is repeated several times until the nerves 

in the bone surface of the painful bone tumor are 

destroyed. Due to the high acoustic absorption and low 

67 

thermal conductivity of the bone cortex, it is possible to 

use a low level of energy and still achieve a localized heating 

effect that will relieve the pain while minimizing damage 

to adjacent tissue, InSightec said. 

“The increasing longevity of the population, along with 

the rise in cancer incidence during the last decade and 

ever-improving treatment outcomes for primary cancers, 

contributes to the growing number of patients living with 

metastatic bone disease,” said Boaz Liberman, MD, head of 

orthopedic oncology of Sheba Medical Center (Tel 

Hashomer, Israel) and lead author of the 31-patient analysis. 

“Increasing focus on cancer patients’ quality of life has 

led to a search for effective pain-relieving treatments with 

fewer short- and long-term side effects,” he said. “These 

preliminary results suggest that the ExAblate treatment 

using MRgFUS has the potential to provide a safe and effective 

noninvasive treatment for patients suffering from 

painful bone metastases.” 

InSightec is currently enrolling patients into an FDAapproved 

Phase III pivotal study to confirm these earlier 

results. It expects to enroll 148 subjects with bone metastases 

who are not candidates to radiation treatments into 

the study at centers throughout the U.S. and around the 

world. 

Alikacem shared with MDD InSightec’s plans for the 

future of the ExAblate after the Phase III study is conducted. 

“If the data are positive, as expected, we plan to file a premarket 

application with the FDA. We also remain focused 

on the uterine fibroids indication, for which the system is 

currently approved and used commercially. “ 

He said the company also has begun an FDA Phase IV 

study pertaining to fibroids. “The purpose of this multi-site 

randomized clinical study is to determine if ExAblate treatment 

can help women with non-hysteroscopically 

resectable uterine fibroids who are diagnosed with unexplained 

infertility become pregnant. Women in this study 

will be randomized with myomectomy surgery,” he said. 

The ExAblate is currently used commercially as a treatment 

for symptomatic uterine fibroids. The system 

received the CE mark for uterine fibroids in 2002 and FDA 

approved the system as a treatment for symptomatic uterine 

fibroids in 2004. 

More than 4,500 symptomatic women have been treated 

with the ExAblate to date, with 92% reporting symptom 

relief up to 36-months after treatment. The ExAblate system 

received CE-mark certification for pain palliation of 

bone metastases in June 2007. 

(This story originally appeared in the December 16, 

2008, edition of Medical Device Daily) 



68 

Swiss team uses non-invasive 

deep brain ablation in study 



InSightec (Tirat Carmel, Israel) reported that a team at 

the University Children’s Hospital (Zurich) has completed a 

10-patient feasibility study testing the use of noninvasive 

transcranial MR-guided focused ultrasound surgery 

(MRgFUS) for the treatment of neuropathic pain. 

According to the company, 10 adult patients diagnosed 

with chronic neuropathic pain underwent non-invasive 

deep brain ablation surgery (central lateral thalamotomy) 

with transcranial MRgFUS and showed improvement in 

pain scores and reduction of pain medication with no 

adverse effects at three months follow-up. This is the first 

study in the world to test non-invasive transcranial focused 

ultrasound as a treatment modality for functional brain disorders, 

InSightec noted. 

“This study showed that we can perform successful 

operations in the depth of the brain without opening the 

cranium or physically penetrating the brain with medical 

tools, something that appeared to be unimaginable only a 

few years ago,” said Daniel Jeanmonod, MD, a neurosurgeon 

at the University of Zurich. “By eliminating any physical 

penetration into the brain, we hope to duplicate the 

therapeutic effects of invasive deep brain ablation without 

the side effects for a wider group of patients.” 

Neurosurgeons currently treat patients with functional 

neurological disorders such as neuropathic pain or 

Parkinson’s disease by inserting a tiny probe through the 

cranium and brain to reach and ablate damaged tissue. For 

the patient, the procedure really is as simple as it sounds. 

Eyal Zadicario, director of Neuro Programs at Insightec, 

told Medical Device Daily that for the patient, instead of 

going in for surgery, they are basically going in for an MRI. 

The patient is sent through an MRI scanner similar to a regular 

diagnostic MRI scanner, he said, only this scanner has 

a special ultrasound system integrated into it which can 

non-invasively ablate tissue inside the brain. Zadicario said 

it is an outpatient procedure and no anesthesia is used at 

all. In the study, he said, the 10 patients were kept under 

watch in a hospital for 24 hours, but nothing was done to 

them during that post-procedure monitoring time. 

InSightec says that the more traditional invasive treatment 

works to alleviate pain and other symptoms, however 

it exposes the patient to complications, including infections, 

bleeding and damage to surrounding brain tissue, 

Jeanmonod explained. Also, only patients whose target tissue 

lies in the clear path of the probe are eligible for the 

invasive procedure, he said. 

“We now have early clinical evidence suggesting that 

transcranial MRgFUS provides a safe and effective way to 

non-invasively ablate tissue deep within the brain,” said 


Ernst Martin, MD, director of the Magnetic Resonance 

Center at the University Children’s Hospital. “While we need 

to monitor these patients further, we are very encouraged 

by the results to date and look forward to continuing our 

research. A non-invasive treatment that reduces the risk of 

infection and bleeding will fill an unmet need for many 

patients who currently have run out of treatment options 

or are unwilling to undergo invasive brain surgery because 

of the risks associated with it.” 

According to InSightec, the Swiss research team is planning 

a larger study for functional brain disorders and 

expands its clinical research to movement disorders, such 

as Parkinson’s disease and tremor, and to other functional 

neurological disorders later this year. Additional sites in 

North America are also expected to initiate clinical research 

programs in functional brain disorders with transcranial 

MRgFUS later this year. 

Zadicario said there are basically three main advantages 

to being able to do this procedure noninvasively: 

Being able to treat tissue in the brain, especially tissue that 

is deep in the brain, without having to cut through normal 

healthy tissue to get there; not being concerned with 

restrictions of getting to the deep brain target as is sometimes 

the case during the minimally invasive method of 

doing this procedure; and of course the patient is not at risk 

of developing the complications associated with surgical 

intervention such as bleeding or infection. 

“When we do it noninvasively under MR guidance . . . we 

basically see the tissue that we treat and treat it,” he said. It 

is a much more accurate method than the surgical method, 

he noted. One patient in the study suffered nerve damage 

from a spinal tumor that led to severe pain and cramps in 

his right arm. The pain persisted for years and the patient 

ultimately reported depression and suicidal thoughts 

because of his condition. Immediately after receiving transcranial 

MRgFUS treatment on his brain, he reported that 

the pain had disappeared. A short time later he was able to 

resume normal activities that his neuropathic pain had prevented 

him from doing, such as gardening and outings in 

the country with his family. 

According to the company, the ExAblate 400 is the first 

system to use MR guided focused ultrasound technology 

that combines MRI – to visualize the body anatomy, plan 

the treatment and monitor treatment outcome in real time 

– and high intensity focused ultrasound to target brain tissue 

non-invasively. MR thermometry allows the physician 

to control and adjust the treatment in real time to ensure 

that the targeted area is fully treated and surrounding tissue 

is spared, InSightec said. The ExAblate 400 is a platform 

for a variety of transcranial indications, such as brain 

tumors, functional neurosurgery, stroke and targeted drug 

delivery, the company noted. The ExAblate 2000, based on 

the same technology, was approved by the FDA in 2004 as 

a treatment for symptomatic uterine fibroids. That system 

received a CE mark for pain palliation of bone metastases in 




69 

June 2007. InSightec is a private company owned by Elbit 

Imaging (Tel Aviv, Israel), General Electric (Fairfield, 

Connecticut), MediTech Advisors (Jerusalem), and employees. 

According to the company, it was founded in 1999 “to 

develop the breakthrough MR guided focused ultrasound 

technology and transform it into the next generation operating 

room.” 

“The Neuropathic pain study performed at Zurich 

demonstrated the feasibility to treat these patients noninvasively 

without adverse events and with very favorable 

preliminary efficacy,” said Dr. Kobi Vortman, President/CEO 

of InSightec, in a company statement. “The results of this 

study set the ground for extensive brain study addressing 

the areas of functional diseases like Parkinson and Epilepsy, 

brain tumors and stroke. This technology has the potential 

to help significant amount of patients while reducing trauma 

and morbidity. To advance this study, InSightec is collaborating 

with leading neurosurgery and neurology institutes 

around the world.” 

Earlier this year the company reported raising $15 million 

from its existing investors. Elbit invested $7.5 million 

and another $7.5 million was expected to be invested by its 

other investors within the next 12 months (Medical Device 

Daily, March 20, 2009). InSightec said the funds would be 

used to expand its R&D efforts, for marketing and sales 

activities, and for general corporate purposes. 





70 

FDA clears cerebral protection 

device from Invatec for CAS 



Patients with carotid artery disease – caused by plaque 

buildup in the carotid arteries that reduces blood flow – are 

at risk of a stroke because of the potential for clots to form 

on the plaque and block the blood flow. But carotid artery 

stenting (CAS), a procedure commonly used to treat the disease, 

also poses a risk of stroke because sometimes a piece 

of the plaque can break away and travel to the brain. 

That’s why companies like Invatec (Roncadelle, Italy) 

are developing cerebral protection devices that can be 

used during CAS procedures to prevent debris from reaching 

the brain. On Friday Invatec said it received FDA 510(k) 

clearance for its Mo.Ma Ultra Proximal cerebral protection 

device for use during CAS. According to the company, the 

device reduces and captures debris released during the 

stenting. The company also said it has completed the 

ARMOUR trial, which demonstrated low stroke and major 

adverse cardiac and cerebrovascular event rates. 

Jack Springer, president of Invatec USA (Bethlehem, 

Pennsylvania), told Medical Device Daily that most of the 

other protection devices on the market require the surgeon 

to cross over the lesion first before the protection device is 

inserted. That results in the opportunity to push or shoot 

debris into the brain via the blood stream, he said. 

Mo.Ma Ultra is a proximal protection device, which 

establishes full-time cerebral protection and control during 

the carotid stenting procedure prior to crossing the internal 

carotid artery lesion, thereby preventing distal 

embolization, Invatec said. Small balloons on the tip and 

proximal shaft are inflated in the external carotid artery 

and the common carotid artery to suspend blood flow during 

the stenting process. These balloons act like endovascular 

surgical clamps, protecting the brain during the procedure, 


“Our device doesn’t require you to cross over the lesion 

first, it shuts down blood flow, stops flow into the brain so 

any debris ... would actually stop where the lesion is, where 

the problem is, and then you actually suck the debris out,” 

using a suction, or retrievable, catheter, Springer said. 

The percutaneous Mo.Ma Ultra requires no surgery, 

Invatec noted. Guide wires, stents and balloon catheters are 


used in this protected environment to treat the target 

lesion through the Mo.Ma Ultra device, which provides stability, 

control and access to the internal carotid artery like a 

guiding catheter or sheath. The suspended blood is then 

aspirated along with any embolic debris to complete the 

procedure safely, the company said. 

“The fundamental aspect of it is you create a protected 

and safe environment before you cross that lesion at all,” 

Chris Frederick, VP of marketing at Invatec USA, told MDD. 

“Therefore you’re not going to cause a potential emboli 

breaking off in your actual treatment of the patient.” 

W. L. Gore & Associates (Flagstaff, Arizona) makes a 

similar device that was approved earlier this year by the 

FDA. The Gore device is designed to reverse the flow of 

blood during stenting procedures. According to Gore, its 

neuroprotection technology reverses the flow of blood at 

the treatment site prior to crossing the lesion so there’s 

almost no chance that particles could escape to the brain. 

Springer said there has been a lot of research published 

on the concept of protection devices and that many experts 

believe these devices are the most important part of the 

CAS procedure and they create the highest risk. Thus, creating 

a protection device that doesn’t throw any debris into 

the blood stream is expected to make the stenting procedure 

safer. 

According to Invatec, results of the 262-patient 

ARMOUR trial support the safety and effectiveness of 

Mo.Ma Ultra for patients at high surgical risk for carotid 

endarterectomy undergoing CAS. Mo.Ma Ultra’s full-time 

protection and control contributed to a low 30-day stroke 

rate of 2.3% and complication rate of 2.7% in the primary 

endpoint 220-patient population set. 

“Proximal Embolic Protection is an important advance 

that gives us more options in the treatment of carotid 

artery disease,” said L. Nelson Hopkins, MD, of State 

University of New York (Buffalo) and co-principal investigator 

of the ARMOUR trial. “The Mo.Ma Ultra combines the 

advantages of carotid endarterectomy with the minimally 

invasive benefits of carotid artery stenting.” 

The Mo.Ma Ultra device is indicated as an embolic protection 

system to contain and remove embolic material 

(thrombus/debris) while performing angioplasty and stenting 

procedures involving lesions of the internal carotid 

artery and/or the carotid bifurcation. The reference diameter 

of the external carotid artery should be between 3 mm 

and 6 mm and the reference diameter of the common 




71 

carotid artery should be between 5 mm and 13 mm, the 

company noted. 

“The primary endpoint results of the ARMOUR trial are 

impressive and support the benefits of proximal protection. 

We look forward to the availability of Mo.Ma Ultra in 

the U.S. market,” said Gary Ansel, MD, of Riverside 

Methodist Hospital (Columbus, Ohio) and co-principal 

investigator of the ARMOUR trial. 

Frederick told MDD that the device appeals to surgeons 

because it is similar to the traditional approach 

they are used to. “Create this environment, clean it out, 

and it’s a very safe way to treat patients with carotid 

artery disease,” he said. 

In addition to being easy to use, Frederick said the system 

will allow physicians to treat more patients – patients 

who really need an endovascular procedure but may not 

have been eligible for the procedure previously. 

“Certain lesions are so tight that you can’t cross with a 

distal protection device or the anatomy is too difficult . . . 

[the Mo.M Ultra] expands the number of patients that are 

going to be able to have a carotid stent procedure who did 

not have that opportunity previously,” Springer said. 

(This story originally appeared in the Oct. 26, 2009, 




72 

Thinnest, strongest material 

molded into sensors, batteries 



Thin is in when it comes to building new medical 

devices. But biomaterials don’t have to struggle with counting 

calories to reach the desirable size. Instead, researchers 

at Kansas State University (Manhattan, Kansas) are fabricating 

graphene – carbon material that is only a single 

atom thick – to then build an ultra-sensitive, bio-driven 

DNA sensor and a high-efficiency bacteria-operated battery. 

“It’s the strongest material in the world at that scale,” 

KSU’s Vikas Berry, assistant professor of chemical engineering, 

told Medical Device Daily. “All the carbon atoms are 

connected to one another via hybridized bonds.” 

Graphene was discovered just five years ago and biological 

interfacing is now taking the material to the next 

level of development. Berry and his team have to use an 

atomic force microscope to see and manipulate the carbon 

sheets that are no bigger than 100 microns across, about 

the same size as a strand of hair. 

What does this material look like “Black,” Berry said. 

“We have been able to suspend graphene in solution and it 

looks totally black.” Which makes sense because it’s exfoliated 

from graphite (the mineral from which pencil lead is 

extracted; it’s also considered the highest grade of coal). 

And because graphite is an electrical conductor, the resulting 

graphene, which also looks a bit like honeycomb or 

chicken wire, may one day replace silicon as the choice 

material for semiconductors. 

But Berry’s team is focused on med-tech applications of 

the 2-D, chemically modified graphene nanostructures. 

The graphene-based invention that’s nearest to reality 

is a DNA sensor for cancer detection. Most current sensors 

are optical, but a graphene-based sensor would be electrical. 

When electrons flow on the graphene, they tend to 

change speed if they encounter DNA. The researchers 

noticed this change by measuring the electrical conductivity. 

“It should not take very long to develop,” Berry said. 

“The preliminary tests have been done. We’ve measured the 

sensitivity. We are further developing this to have a sensor 

that has absolutely no noise. We want to see how sensitive 

the system is. Our first set of experiments was 20 base 

pairs. Now we want to see different lengths of DNA and if 

we can hybridize complementary DNA to different regions 

of graphene. In one to two years from now, we should see a 

very sensitive DNA sensor. 

“It’s a fascinating material to work with,” Berry said of 

his work, which was published in Nano Letters. “The most 

significant feature of graphene is that the electrons can 

travel without interruptions at speeds close to that of light 


at room temperature. Usually you have to go near zero 

Kelvin – that’s about 450 degrees below zero Fahrenheit to 

get electrons to move at ultra high speeds.” 

He’s using the same graphene to develop a bacteriaoperated 

battery by loading the thin sheets of biomaterial 

with antibodies and flowing bacteria across the surface. 

“We have wrapped bacteria cells with graphene sheets,” 

he said. “The idea, and it’s too early for this, is to use this as 

a interface between bacterial cells and external nanodevice. 

We want to ultimately have a very strong interfacing 

with bacterium by a material which is very high in conductivity, 

which is graphene. By doing this interfacing, electrons 

produced on the surface can be extracted.” 

Berry’s team found that the graphene, with tethered 

antibodies, wraps itself around an individual bacterium and 

remains alive for 12 hours. How does this translate into a 

battery By specifically using geobacter, a type of bacteria 

known to produce electrons, it can be wrapped with 

graphene to produce electricity. 

A resulting battery, he said, is “futuristic work.” He said 

fellow researchers currently working with geobacter to 

develop batteries have had little success because efficiency 

is very low. 

“But with graphene, you can extract more electrons,” he 

said. “Engineering that into a battery would be the next 

step. 

“Materials science is an incredible field with several 

exploitable quantum effects occurring at molecular scale, 

and biology is a remarkable field with a variety of specific 

biochemical mechanisms,” Berry said. “But for the most part 

the two fields are isolated. If you join these two fields, the 

possibilities are going to be immense. For example, one can 

think of a bacterium as a machine with molecular scale 

components and one can exploit the functioning of those 

components in a material device.” 






Hybrid bioelectronic platform 

to yield better devices, tests 



The Holy Grail for just about any medical device is the 

ability to seamlessly interact with human biology. 

Scientists have yet to duplicate the sophistication of living 

organisms. But combine electronic circuits with biological 

components and the sky is the limit in terms of potential 

medical applications for devices that yield drastically 

increased efficiency. 

Researchers at the Lawrence Livermore National 

Laboratory (LLNL; Livermore, California) have just reported 

a breakthrough in this area with the invention of a versatile 

hybrid platform that uses lipid-coated nanowires to 

build prototype bionanoelectronic devices. 

“The idea came from looking at all the sophisticated 

structures of biological proteins. These machines can do 

things that rival or exceed the best we can do with the 

macroscopic devices,” Aleksandr Noy, PhD, the LLNL lead 

scientist on the project, told Medical Device Daily. “The 

immediate task was to see if we can make them work in 

electronic circuits. The longer-term goal would be to use a 

combination of electronic and biological components to 

create structures that can act as very efficient electronic 

cellular interfaces, almost as a universal translator between 

the cellular signaling and electronic signaling.” 

Noy, who is also Theme Leader for the LLNL Physical 

and Life Sciences Directorate, reported his complex findings 

in the Proceedings of the National Academy of 

Sciences. 

“Obviously the work is an early stage demonstration, 

so I can only speculate about practical use, but I would like 

to see it used in smart prosthetics that could be controlled 

directly by the nerve impulses from the brain,” he said. 

Other applications resulting from the mingling of biological 

components with electronic circuits run the gamut 

from enhanced biosensing and diagnostic tools to 

advanced neural prosthetics such as cochlear implants. The 

platform could even increase the efficiency of computers. 

Noy chose to work at the nanoscale to accomplish this 

feat because “Nanoscale gives me the ability to use electronic 

components that have the same size and scale as 

biological molecules,” he said. “It makes the interface more 

efficient and a lot less cumbersome.” 

Many researchers have previously attempted to integrate 

biological systems with microelectronics, but none 

got to this point of seamless material-level incorporation. 

“But with the creation of even smaller nanomaterials 

that are comparable to the size of biological molecules, we 

can integrate the systems at an even more localized level,” 

Noy said. 

73 

The new hybrid platform uses shielded nanowires that 

are coated with a continuous lipid bilayer. 

“We made silicon nanowire transistors on a chip, then 

assembled a lipid membrane on the nanowire – essentially 

mimicking the cell wall – and then we put the membrane 

protein into the lipid bilayer to complete the device,” he 

said. 

The advantages of this technology platform over existing 

electronic devices include reduced size, better sensitivity 

as well as the potential to make much more sophisticated 

circuitry in the future. 

The LLNL team used lipid membranes, which are widespread 

in biological cells. The membranes form a stable, 

self-healing and almost impenetrable barrier to ions and 

small molecules. 

“These lipid membranes also can house an unlimited 

number of protein machines that perform a large number 

of critical recognition, transport and signal transduction 

functions in the cell,” said Nipun Misra, a University of 

California Berkeley graduate student and a co-author on 

the paper. 

What results is a shielded-wire configuration, which 

allowed the researchers to use membrane pores as the only 

pathway for the ions to reach the nanowires. 

“This is how we can use the nanowire device to monitor 

specific transport and also to control the membrane 

protein,” Noy said. 

By changing the gate voltage of the device, the team 

showed that they can open and close the membrane pore 

electronically. 

Going forward, Noy said his group is worked to develop 

various applications for the platform. 

“I am thinking about this structure more as a platform 

technology. We can put other membrane proteins in the 

bilayer and make them perform other tasks,” he said. “The 

long-term goal would be to develop viable bionanoelectronic 

devices that perform functions that are robust 

enough and complex enough to merit use in real applications; 

obviously biomedical device use is a prime target.” 

(This story originally appeared in the Aug. 17, 2009 edition 




74 

LenSar developing laser 

technology for cataracts 



LenSar (New York), a startup company, says it is developing 

a new laser therapy that could potentially remove 

cataracts from people’s eyes more efficiently and with 

greater precision than the current technology used to treat 

cataracts. The company presented the technology at the 

recent American Academy of Ophthalmology (San 

Francisco) meeting. 

Joseph Dello Russo, MD, a New York ophthalmologist 

who was among the first doctors to perform laser eye surgery, 

told Medical Device Daily that he has watched 

LenSar’s technology develop from a concept in 2004 to an 

actual laser, which the company began testing on patients 

in Mexico about a year and a half ago. More recently, the 

company began testing the laser on patients in the 

Philippines, he said. 

Russo has been affiliated with LenSar since its inception 

and up until about six months ago was on the company’s 

board. 

LenSar plans to continue testing human patients outside 

the U.S. until it has collected enough data to support 

that the technology actually works, Russo said. The company 

said it plans to start treating patients in the U.S. if the 

FDA will consider the technology to be safe an effective, 

based on the data. 

Cataracts are currently treated with a device known as 

a Phacoemulsifier, which uses ultrasound waves to break 

up the contents of the cataract and, according to LenSar, 

was nicknamed in the mid-seventies a “laser.” 

“People think of it as a laser, which it’s not,” Russo said. 

While the current technology is generally considered very 

safe, he said that results largely depend on the skill of the 

surgeon doing the procedure. 

LenSar believes that its laser will make cataract surgery 

easier to perform. Although the new device will cost more 

than the existing technology, LenSar says the speed of surgery 

may compensate for that by allowing more procedures 

to be performed in less time. 

Russo explained that the new laser technology has the 

potential to allow for the use of premium implants, which 

set up bifocal vision as well as provide a better way to treat 

astigmatism. Such implants, Russo said, work best if they 

are implanted exactly in the center of the eye, which will 

depend upon the perfection of the capsulotomy – the incision 

into the crystalline lens of the eye to remove cataracts 

– which is currently done by hand. “Most of us can do that 

pretty good, but there’s nothing like a laser that can do it 

precise[ly],” he said. 

Improved precision would also make the procedure 

safer, Russo said. “It’s taking the surgeon out somewhat 


and making the laser do the work so it can be consistent all 

the time.” 

But only time – and more clinical testing – will tell if 

LenSar’s new laser technology will work. So far though, 

Russo says the results look promising. According to LenSar, 

the laser has been used in about 100 operations outside the 

U.S. 

The company was formed by LenSar’s CEO, Randy Frey, 

PhD, a scientist best known for the LASIK laser he developed, 


LenSar acknowledged that it is in a head-to-head competition 

to be the first to commercialize the laser technology. 

However, Frey claims that he holds important patent 

applications, which allow the company to focus on R&D and 

pay less attention to competitors. He believes that LenSar’s 

patents will prevail and will have a legal claim on any such 

devices, regardless of their maker. 

Russo told MDD that he suspects that LenSar’s 

strongest competitor is a company called LenSx Lasers 

(Aliso Viejo, California). “Either LenSx or LenSar is going to 

be first,” he said, adding, “I’m not sure it’s important to be 

first or not.” 

According to LenSar, the real financial benefit for the 

company is not in the sale of the laser but in the “royaltylike” 

fee that is paid to the company each time the laser is 

used. 






Tru-Flo a novel approach 

for urinary catheter market 

By OMAR FORD 


Gordon Atkinson survived prostate surgery, but his 

most frustrating hurdle was having to use a catheter and 

bag following the procedure. The bag was difficult to conceal 

and was awkward when wearing shorts (he lived in 

Florida at the time) and engaging in leisure activities. 

“He was incredibly uncomfortable with the catheter,” 

Jeff Hale, of Link-It Medical (Hickory, North Carolina) told 

Medical Device Daily. “He couldn’t sleep at night or wear 

shorts. The catheter bag would slide down and it would just 

be awkward.” 

“I love to fish and sail, but the catheter and bag made it 

difficult for me to feel comfortable doing those things,” 

Atkinson said. I had all this tubing hanging on my leg, and I 

had to be careful not to snag it on anything. I definitely 

couldn’t wear shorts. If the tubing disconnects, which can 

easily happen, urine runs down your leg and soils your 

pants. I knew there had to be a better way.” 

With a background in fluid dynamics, Atkinson began 

tinkering away to make the device easier to use. He then 

teamed up with his doctor Mutch Yadven MD, to patent and 

make improvements to the concept. 

“When I showed it to Mitch, he said, ‘Do you know what 

you’ve done’” Atkinson said. “I think we both knew this 

valve could have life-changing potential.” 

The duo then teamed up with Hale’s company Link-It 

Medical and selected neophyte med-tech company 

ProtekMed (Hickory, North Carolina) to manufacture the 

device, which has been named the Tru-Flo urinary catheter 

valve. 

The company reported launching the device. It’s a 

Class I device and it’s considered a urinary accessory, so 

there is no need for a 510(k) or PMA according to the company. 

“What this valve does is, it allows the patient to have 

control over the drainage of urine,” Hale told MDD. “This is 

the first of its kind in the U.S. market. Interestingly enough 

there have been quite a few valves in Europe that have 

attempted to accomplish what we’re doing with Tru-Flo. But 

[ProtekMed] is looking at European market which is much 

more mature, but our primary focus is in the U.S.” 

The device itself is being touted as a huge game changer 

in the quality of life for catheter patients. 

Designed to be used in place of a bag, the valve connects 

to the end of the catheter tube and slides open and 

closed easily with one hand. With a secure, leak-free seal, a 

Tru-flo-equipped catheter can be drained directly into a 

commode at the convenience of the patient. The valve universally 

adapts to all Foley and Supra-pubic catheter systems. 

75 

By eliminating the bag and utilizing shorter catheter 

tubing, the entire catheter system is easily concealed 

thanks to Tru-flo - helping to restore patient comfort and 

dignity. And with no recessed or undercut external surfaces 

that can harbor bacteria, the Tru-flo valve has important 

design features for infection prevention. 

The company said that for patients utilizing the valve, 

the device should be opened every three-to-four hours initially. 

Some patients may have the urge to void and should 

open the valve as this occurs. The valve can be used safely 

overnight, or a bedside drainage bag may be attached 

before bed, reducing nocturia, and the valve replaced in the 

morning. 

Patient indications for use of the Tru-flo valve include 

the following: 

• Conditions of chronic urinary retention; 

• Conditions of acute urinary retention; 

• Other medical conditions requiring in-dwelling 

catheters. 

Contraindications include a high-pressure neurogenic 

bladder, a history of autonomic dysreflexia, a febrile UTI, 

and situations following any procedure or trauma where 

there is a possibility for urinary extravasation and urinary 

drainage is needed for optimal tissue repair, such as TURBT, 

bladder repair or trauma, or radical prostatectomy. Relative 

contraindications are gross hematuria with clot. 

“There has been a lot of interest with this device,” Hale 

told MDD. “We’ve got orders for [Tru-Flo] that have been 

booked and we look to have our first sales of the device [in 

the near future].” 





76 

Tru-D shows promise for 

cleaning hospital rooms 



A device made by Lumalier (Memphis, Tennessee) is 

showing promise in its ability to clean hospital rooms using 

ultraviolet germicidal energy to decontaminate air and surfaces. 

Lumalier reported that in a study presented at the 49th 

Interscience Conference on Antimicrobial Agents and 

Chemotherapy in San Francisco, researchers used its 

mobile, automated UV device to decontaminate hospital 

rooms at the Cleveland Veterans Affairs (VA) Medical Center 

in Ohio and analyzed its ability to remove troublesome bacteria, 

including C. difficile spores. According to the company, 

the device, known as Tru-D, uses reflected UVC germicidal 

energy to decontaminate air and surfaces, including 

those in primary shadows. 

Chuck Dunn, president/CEO of Lumalier, told Medical 

Device Daily that the Tru-D was invented by Jeffrey Deal, 

MD, an ear, nose and throat surgeon that in his procedures 

– a lot of which involved young children – he was having 

infection problems. Deal sourced those problems of infection 

to the environmental surfaces in his operating room 

suite, which often weren’t being cleaned properly, Dunn 

said. He said the surfaces the Tru-D is designed to clean are 

considered non-critical surfaces. 

The company developed a method of measuring 

reflected dose throughout the space to ensure that shadows 

in a complex environment would be disinfected, Dunn 

said. By complex environment, he means all of the hoses, 

tubes, poles, keyboards found in the operating room environment. 

Dunn added that very often the machines that get 

touched most with hands are the ones that environmental 

services workers, or cleaners, are afraid to touch. 

Now, the device is beginning to attract attention from 

researchers. 

Curtis Donskey, MD, chair of the infection control committee 

at the Cleveland VA Medical Center, said that Tru-D 

is a “novel method for cleaning hospital rooms . . . easy to 

use . . . and more effective than standard disinfection for 

removing hardy bacteria.” According to Donskey, the Tru-D 

was able to decontaminate all surfaces in 40 hospital 

rooms, including hard-to-clean surfaces such as the undersides 

of tables.” Lumalier noted that 18% of sites under the 

edges of bedside tables were still contaminated with MRSA 

after routine hospital cleaning, versus 0% after Tru-D use. 

Research revealed that disinfection with Tru-D reduced the 

frequency of positive methicillin-resistant Staphylococcus 

aureus (MRSA) and vancomycin-resistant enterococci (VRE) 

cultures by 89%, the company said. 

“C. difficile spores are especially challenging for hospital 

staff,” Donskey said. On inoculated surfaces, application 


of Tru-D using the spore setting consistently reduced 

recovery of C. difficile spores and MRSA by about two to 

three logs, the company noted. Similar VRE reduction was 

achieved in about half the time using a lower dose setting. 

“The UV device is computerized and can assess how much 

is needed for decontamination by measuring the reflected 

UV radiation from surfaces in the room,” Donskey said. “It’s 

inexpensive to operate and requires no cleaning supplies.” 

After viewing results, Donskey requested the purchase of 

several Tru-D units for the Cleveland VA Medical Center, 

Lumalier said. 

Dunn told MDD that for now, Lumalier is not making 

claims that the Tru-D reduces hospital-acquired infections, 

however that is a possibility in the future, if the company 

obtains the data to back up such claims. 

“At present, the studies and the research are simply in 

regard to our ability to clean. We can state that we reduce 

pathogens – that’s clear that we do – we cannot state that 

that reduction of pathogens may or will lead to a reduction 

of hospital-acquired infections because we don’t have that 

data yet,” Dunn said. 

However, such data might not be that far off for 

Lumalier. Dunn said Donskey’s study is about to enter its 

third phase during which he will attempt to identify 

whether or not the Tru-D reduces infections. 

“UVC radiation is an exciting new technology for disinfecting 

patient rooms and contaminated surfaces in healthcare,” 

said Luke Chen, assistant professor of medicine in 

the Division of Infectious Diseases at Duke University 

Medical Center. “The Tru-D device demonstrated consistency 

and rapidity in killing microorganisms. There is potential 

to use this technology to rapidly clean and turn around 

patient rooms, clinic space or waiting rooms.” 

John Boyce, MD, chief of the Infectious Diseases Section 

at the Hospital of Saint Raphael and clinical professor of 

medicine at Yale University School of Medicine, said that the 

device is easy to employ and that it can reduce the number 

of positive bacterial cultures “substantially.” 

According to Dunn, there are currently three ways to 

clean a hospital room: 

• mop and bucket, spray and wipe, which Dunn says is 

not a very effective method; 

• vaporized hydrogen peroxide, a new technology 

requiring specially-trained operators and four to six hours 

to clean a room and the hydrogen peroxide cannot be let 

out of the room, making it an effective method, but not 

practical for use in the quick room turn environment of 

healthcare, Dunn said. 

• Tru-D, which Dunn says is “very promising” to be both 

effective and fast. 

Boyce authored a 2008 disinfection study of vaporized 

hydrogen peroxide. “The UV radiation device has the potential 

to be effective, faster, and less expensive to operate,” he 

said. 

The company noted that Deal worked closely with 




77 

Lumalier to insure that Tru-D technology is readily available 

for broad deployment. Last year the company received 

the distribution rights for the device from Deal. 





78 

Luminex gets 510(k) clearance 

for xTAG cystic fibrosis test 



Luminex (Austin, Texas) reported that it has received 

FDA 510(k) clearance for a new cystic fibrosis (CF) test: the 

xTAG Cystic Fibrosis 39 Kit v2, which is designed to detect 

the 39 CF-causing gene mutations. It is used to screen 

potential parents to determine if they are carriers of CF 

mutations, as an aid in newborn screening and in confirmatory 

diagnostic testing in newborns and children. 

This test is actually a new, improved version for 

Luminex. The first iteration was cleared by the FDA in 2005. 

“Compared to the previous version, this is faster and 

requires less labor,” Jeremy Bridge-Cook, PhD, senior VP, 

Assay Group at Luminex, told Medical Device Daily. “The 

previous version took about 6.5 hours and this version 

takes about 4.5-5 hours depending on the model of thermocycler 

used. And the labor time goes down from one 

hour and 20 minutes to 50 minutes. The second difference 

is that the previous versions of the product recommended 

which enzymes to use, but didn’t provide them. In this version, 

all of the reagents needed are incorporated in the kit.” 

There are about 70,000 people worldwide who have 

the disease with 30,000 in the U.S. There is no cure and the 

median predicted age of survival is 37.4 years, according to 

the Cystic Fibrosis Foundation (CFF; Bethesda, 

Maryland). 

CF is inherited from parents who carry the mutated 

genes but are not sick with the disease. It causes mucus to 

build up and clog the lungs, making it difficult to breathe. 

That sticky overproduction of mucus can also cause bacteria 

to stick to airways, leading to infections and lung damage. 

But the problems with CF don’t stop in the lungs. 

Mucus can also affect the digestive tract and pancreas, 

wreaking havoc on the body’s ability to digest nutrients. 

It is caused by mutations in the CF transmembrane conductance 

regulator (CFTR) gene. More than 1,500 such 

mutations have been identified to date. 

Carrier screening is recommended for couples planning 

a pregnancy as it is possible for a person to carry a CFcausing 

gene mutation and have no symptoms of the disease. 

CFF reports that more than 10 million Americans are 

symptomless carriers of a CFTR gene mutation. Early diagnosis 

of CF in babies allows for earlier treatment intervention 

and can help improve a child’s long-term health and 

quality of life. 

With no cure in sight, the value of a test can be put to 

question. But Bridge-Cook said that prospective parents 

should be tested because, “If both parents have a CF mutation, 

there’s a one in four chance that a baby would have CF. 

The utility of information in that context is that it enables 

people to make more informed choices from a reproductive 


standpoint. 

“The other intended indication for the tests is as an aid 

in diagnosis of newborns,” he said. “Babies who are diagnosed 

early do better and live longer than kids who are 

diagnosed later. One of the other aspects of CF is pancreatic 

insufficiency. That condition means babies or young children 

with CF start to have digestive problems. If its diagnosed 

early, dietary measures can be taken that lead to 

much better outcomes and longer survival.” 

The xTAG Cystic Fibrosis 39 Kit v2 screens for the 23 

CFTR gene mutations and four variants (polymorphisms) 

recommended by the American College of Medical Genetics 

(ACMG) and American College of Obstetricians and 

Gynecologists (ACOG), and 16 additional CFTR gene mutations 

from human blood specimens in a few hours. 

The xTAG Cystic Fibrosis 39 Kit v2 offers physicians 

the ability to select the CFTR gene mutations for which they 

want to test. Doctors can choose to test a patient for the 23 

ACMG/ACOG-recommended gene mutations or the entire 

panel of 39 CFTR gene mutations. 

This newer version of the xTAG Cystic Fibrosis 39 Kit 

v2 will allow labs to avoid having different platforms for 

various testing purposes and save time and resources. And 

like the first generation xTAG CF test, the new xTAG Cystic 

Fibrosis 39 Kit v2 does not require reflex testing. All results 

are revealed and available for analysis at each run, if necessary. 

Although Bridge-Cook would not discuss the cost of 

the test, he did say that CPT coding for reimbursement is 

well established and that the cost of the tests is less than 

the current reimbursement level, making it “fairly attractive.” 

Earlier this year Luminex launched the xTAG Cystic 

Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2, as CEmarked 

in vitro diagnostics under the European Directive 

on In Vitro Diagnostic Medical Devices. According to the 

European Cystic Fibrosis Society, as many as one in 30 

Europeans are carriers of a CF-causing gene mutation. The 

xTAG Cystic Fibrosis 71 Kit v2 can screen for all of the genetic 

mutations in the xTAG Cystic Fibrosis 39 Kit v2 plus an 

additional 32 mutations including those that are typically 

found in specific ethnic populations (MDD, June 11, 2009). 

Bridge-Cook said a version of the xTAG Cystic Fibrosis 

71 Kit is on the way for FDA review and U.S. launch. 






Luminous still in 510(k) 

path with glucose monitor 

By OMAR FORD 


Imagine being the CEO of a small med-tech company 

with a surefire product and nearly $35 million in venture 

capital. The company is all set to get the green light from 

the FDA and start clinical trials. Then it happens. The FDA 

throws the company a curveball and says that the technology 

the company is appropriating isn’t something they’ve 

dealt with before and they’re not quite so sure how to evaluate 

it. The chances of a 510(k) diminish and a PMA seems 

to be the only option. 

It’s a scenario that small startup Luminous (Carlsbad, 

California) faced when it went to get approval for its automated 

glucose monitor. Previously, Luminous was planning 

to use a sensing technology based on near-infrared spectrometry. 

Infrared spectrometry was untested waters when 

it came to using a glucose monitor, so that’s where the 

issue came with the FDA, the company said. 

“The technology worked,” Dave McMahon VP of 

Marketing for Luminous told Medical Device Daily. “We 

went and met with the FDA over a year ago about the 

device. The outcome was that [FDA] said this is technology 

that they weren’t sure how to evaluate. They also told us 

that if we went that route it was going to be a pretty large 

clinical trial that was needed to show efficacy of the device. 

The bottom line was that we could go ahead and file the 

device for a 510(k) application but it sounded like we would 

have had to take the PMA route and a PMA wasn’t in our 

timeline. Fortunately for us we had a backup plan.” 

That plan included a deal with a major supplier (that 

the company hasn’t yet revealed) of electrochemical sensors 

for exclusive rights to incorporate its glucose sensor 

into Luminous’ automated blood glucose monitor. This sensor 

has already been FDA-approved and would put 

Luminous in a better position to get its entire product 

approved. As of press time the company had not settled on 

a name for the device. 

“It was not an easy decision for us to make,” McMahon 

said. “The company was founded on this technology. 

Luminous said that it is preparing for pivotal clinical trials 

and a 510(k) application in 2010. If the company has 

favorable results in trials and gets an FDA approval, it plans 

to launch the device at the end of 2010. 

Glucose oxidase electrochemistry has been used to 

measure glucose with near laboratory accuracy in point-ofcare 

devices for many years. The FDA has recently 

expressed concern about the use of test strip-based glucose 

meters that are not cleared to manage glucose in hospitalized 

patients. The Luminous product is being designed 

to automate the process of glucose monitoring while 

simultaneously raising the bar for measurement accuracy 

at the point of care. 

And it has had significant support in funding to do so. 

Last year Luminous reported completing a $23.5 million 

round Series B financing. Adams Street Partners led the 

investment, joined by new investors RiverVest Venture 

Partners, and Finistere Ventures. Existing investors De 

Novo Ventures and Latterell Venture Partners also participated 

in the round. 

The company previously completed a $9 million round 

of Series A funding in 2005. 

“We’re seeking a Series C round in 1Q10 to get us onto 

the market,” McMahon told MDD. 

To further garner support for the device Luminous will 

be displaying it at the Society of Critical Care 

Medicine’s (Mount Prospect, Illinois) Post-Congress 

Conference to be held in Key West, Florida from January 13th 

January 15th, 2010. 

If successful the company could become a huge player 

in a market with a strong clinical demand for glycemic control. 

To date, multiple clinical studies have demonstrated 

significant morbidity and mortality benefits from controlling 

glucose levels in critical care patients. As a result, clinicians 

have rapidly adopted glycemic control procedures 

but struggle with inadequate and time consuming manual 

methods. 

The device would eliminate these time consuming 

methods and eliminate a lot of human error introduced into 

the process the company says. 



79 



80 

Mardil offers ‘heart-y’ hug 

system to treat mitral valve 

By DON LONG 


Everybody needs a hug. And many people, primarily 

heart patients who are experiencing mitral valve regurgitation, 

need it more than others. 

That’s the foundation concept for a new device system, 

being developed by developmental firm Mardil (Haifa, 

Israel/Morrisville, North Carolina), intended to correct 

mitral valve regurgitation, a condition in which blood leaks 

through the valve, from the left ventricle into the left atrium 

of the heart, greatly reducing its efficiency and producing 

the debilitating symptoms of congestive heart failure. 

The company, founded two years ago and with its roots 

in Israel, has just reported the launch of first-in-man clinical 

trials of its Basal Annuloplasty of the Cardia Externally 

device (or BACE), as a way of squeezing the heart as a 

method for improving the function of the mitral valve. 

The first patient in Mardil’s 20-patient pilot study was 

implanted with the BACE device last month in India. The 

company reported that the patient had a significant 

improvement in heart function after the procedure. 

Gopal Muppirala, the company’s CEO based in the U.S., 

told Medical Device Daily that improved function can be 

determined even before the implantation of the BACE 

device is completed, with the use of a real-time echocardiogram. 

The device consists of what Muppirala called four 

“chambers,” essentially inflatable silicone-wrapped, which 

are placed around the heart and then used to apply pressure 

by squeezing the muscles and other tissues around 

the mitral valve – in essence, giving it a hug – so that the 

valve performs more efficiently and shuts off the damaging 

leakage of blood. 

Muppirala said that one of the chief benefits of the 

BACE device is that it offers an alternative, in a majority of 

mitral valve cases, for those patients with a valve so damaged 

that it needs replacement. 

These chambers, in the system’s first iteration, are 

placed during an open surgical procedure which does not 

require stopping the heart. And Muppirala said that the 

company is working to develop methodology for implantation 

via a cardio-thoracotomy, a much less invasive procedure. 

Once placed around the heart, the chambers are filled 

with saline, exerting variable amounts of pressure, with the 

surgeon able to make the necessary adjustments of that 

pressure. As the heart alters its function, the pressure of 

these chambers can then be changed in follow-up adjustments. 

No cannula for access into the body is needed to do 

this, Muppirala said. Salilne can simply be injected through 


the skin into a tube running under the skin and providing 

access to the four chambers. 

Muppirala emphasized that the device is not intended 

to treat patients that have valves that are defective in structure 

as a result of disease or faulty architecture; defective 

valves will continue to be addressed by valve replacement, 

he said. 

Rather, the BACE system addresses those conditions in 

which the valve can work properly but the heart lacks the 

necessary strength to make it work effectively. 

He said that this target pool – citing his conversations 

with cardiovascular surgeon experts in the field – may be 

up to 2 million patients in the U.S. and outnumbers those 

with problems as the result of a valve that is diseased or 

badly misshapen. 

Muppirala told MDD that the company is hoping to file 

for an investigational device exemption with the FDA in 

August or September, and that the company recently met 

with the FDA to begin hammering out details for the protocol 

of the IDE study. 

With approval of the IDE, Mardil plans to launch a multinational 

clinical trial in the U.S., Canada, Israel, Australia and 

Europe in the fall of this year. 

“Mardil’s concept is truly revolutionary in its approach 

in that the device simultaneously treats valvular dysfunction 

while supporting the weakened ventricular muscle, the 

latter of which is not being adequately addressed by the 

current therapies on the market,” said Lishan Aklog, MD, 

chief of cardiovascular surgery at St. Joseph’s Hospital 

(Phoenix). 

Mardil is emphasizing the much less invasive approach 

to the problem of regurgitation, and the avoidance of the 

risks of open surgery for valve replacement. It cites a mortality 

rate of up to 10% for patients undergoing a mitral 

valve repair in conjunction with coronary artery bypass 

surgery. The BACE device was pioneered by Jai Raman, MD, 

a cardiovascular surgeon attempting to develop a less risky 

strategy for this therapy. 

A professor of surgery and director of adult cardiac 

surgery and cardiothoracic surgical research at the 

University of Chicago, Raman said that the system is “the 

next-generation treatment for mitral valve regurgitation” 

because it addresses “the root cause of the condition, a 

heart muscle that is weakened, stretched and enlarged. 

BACE corrects the functional abnormality that leads to 

mitral regurgitation, whereas current devices on the market 

focus on replacing or repairing valves that are structurally 

normal.” 

Muppirala said that besides avoiding the side effects 

and potential mortality associated with valve replacement, 

the system can be offered at much reduced cost. 

He said that the company was launched with seed 

funding from venture capital funds out of India and that it 

currently is on the look-out to raise an additional $20 million 

to carry it through the planned multinational clinical 




81 

trial. 

At least two other companies are pursuing the “hugging” 

strategy for strengthening the heart. Acorn 

Cardiovascular (St. Paul, Minnesota) has developed the 

CorCap, a mesh wrap implanted around the heart to provide 

ventricular support. 

And Paracor (Sunnyvale, California) has developed the 

HeartNet, calling it “super-elastic” nitinol wrapping placed 

around the heart to prevent the additional enlargement 

resulting from congestive heart failure. 





82 

Bullet Cage IDE an example 

of do-it-yourself perseverance 


By OMAR FORD 


What do you do when you’ve got this great idea for a 

device but have no funding to see it through the FDA regulatory 

process in a timely fashion 

Some might wait and raise the appropriate funding to 

get the device through the regulatory path, but if the inventor 

is anything like Sanford Clinic Neurosurgeon, Wilson 

Asfora, MD, then waiting to make the device isn’t even a 

consideration. It’s an after thought. 

Asfora developed the Asfora Bullet Cage, a device used 

to in posterior lumbar interbody fusion surgeries to treat 

degenerative disc disease. Earlier this month he received 

FDA clearance to market the device after 10 years of developing 

it. Toward the end of the regulatory process Asfora 

worked closely with Sanford Health (Sioux Falls, South 

Dakota) to market the device. 

“When I went into neurosurgery it was for fun,” Asfora 

told Medical Device Daily. “Money was never an option.” 

Indeed it wasn’t, since Asfora went through the IDE 

process for his device without any sponsorship and in one 

sole center, his private practice. 

“Doing an IDE by oneself is quite difficult and it takes a 

long time,” he joked. “I was the only investigator and it took 

me 10 years to get enough patients. But the rate of fusion 

for the device is the highest rate of fusion of any cage technology. 

“The idea of the cage isn’t mine I simply improved 

upon it.” 

Fusion cage technology was originally designed more 

than a decade ago, and was used to help the spine heal 

between the vertebral bodies rather than along the back of 

the spine. A more stable fusion is said to be obtained once 

the disc between the vertebral bodies is removed and 

replaced with cages and bone graft. 

Asfora decided to go with a cage that was shaped much 

like a bullet – because of the relative ease of implanting it 

in a patient. “The pointed end was what really made the 

device simple to implant in a patient,” he said. 

The device is set to launch in October and there are no 

current plans to seek marketing in Europe. Asfora’s own 

company, Medical Designs (Sioux Falls) will be manufacturing 

the device. 

“We congratulate Dr. Asfora on the FDA approval of his 

spinal implant,” said Dave Link, Sanford Health Executive 

Vice President. 

“At Sanford Health, our goal is to foster an environment 

which supports the efforts of our physicians to develop 

innovative solutions for the global healthcare market.” 

Asfora currently serves as a Neurosurgeon at Sanford 

Clinic in Sioux Falls, South Dakota. He specializes in adult 

and pediatric neurosurgery, spine surgery, brain tumor surgery, 

cerebrovascular surgery, peripheral nerve surgery, 

radiosurgery and functional neurosurgery including deep 

brain stimulation for movement disorders. Asfora is board 

certified with the American Board of Neurological Surgery 

and the Royal College of Physicians and Surgeons of 

Canada. Asfora has been with Sanford Health since 2007 

and has worked as a Neurosurgeon since 1989. 

In addition, he has developed numerous medical 

devices in use at hospitals around the world including: 

— The Subdural Evacuating Port System (SEPS), a minimally 

invasive life saving device used to treat subdural 

hematomas and promote brain expansion without entering 

the subdural space. SEPS is now marketed globally by 

Medtronic (Minneapolis). 

— The Dakota Knife, a surgical instrument for the transection 

of the carpal ligament in open, limited-open, or minimally 

invasive carpal tunnel surgery. 

— The Odontoid Curved Drill Guide, a surgical tool for anterior 

screw fixation of odontoid fractures. The device is particularly 

useful in barrel chested patients. 

Through a research affiliation with Sanford Health, 

Asfora is currently leading a nationwide team of engineers, 

clinicians and regulatory experts in the development of 

new medical technologies for use in the fields of pain therapy, 

vascular surgery and pediatric diagnostics. 






MTI’s ArterioVision a new option 

in testing for cardio illnesses 

By OMAR FORD 

Medical Device Daily Staff writer 

Most men in Gary Thompson’s family didn’t make it to 

the age of 50. Heart disease was always the culprit, so when 

Thompson came up on his 50th birthday he undertook a 

wide assortment of tests. All his tests came back saying he 

was relatively in good shape. So six days after turning 50, 

he took part in the Los Angeles Marathon, and 20 miles into 

it he began having a heart attack. 

Thompson survived the ordeal and went on a personal 

quest to find a better way to test for the presence of cardiovascular 

disease. After undergoing a new and experimental 

ultrasound like test at the University of California 

and having a visibly shaken clinician tell him that he had 

the thickest arteries that were in a living person, 

Thompson’s initial quest was over and a new mission to 

bring this test to market had begun. 

To do so he founded a company Medical 

Technologies International (MTI; Palm Desert, 

California) to bring the test, which is called ArterioVision, to 

the clinical arena. Thompson is now the chairman/CEO of 

the company. 

ArterioVision had its roots in a test designed for NASA 

to detect the presence of ice on Mars. The technology was 

originally created at in 1966 to interpret images sent from 

space. That software, which was invented to process pictures 

from several missions, including the Voyagers and 

Mars Reconnaissance Orbiter, forms the foundation of the 

ArterioVision carotid intima-media thickness (CIMT test). 

The repurposed software – is now used to measure the 

thickness or the edge of arteries in the human body. 

“I think this is a disruptive technology and I mean that 

in a good way,” Kelly Nardoni Senior Vice President of MTI 

told Medical Device Daily. “It’s standard for us to test indicators 

such as cholesterol, blood pressure . . . but I think 

this adds another tool for us to look at when determining 

the condition of a patient’s heart. I don’t think it replaces 

any of those other indicators, but rather it adds a new 

dimension to testing.” 

She noted that Thompson had been through nearly 

every kind of test and checked out to be fine, but when he 

had undergone testing through the ArterioVision test it 

immediately identified the diseased state of his arteries. 

“I recognized the medical value of the technology 

immediately,” Thompson said. “I knew there was no other 

test that could give doctors an early read on cardiovascular 

health.” Thompson added that if a patient were “physically 

fit, with no visible symptoms, other cardiovascular tests 

may miss key risk.” 

The ArterioVision CIMT test uses ultrasound technology 

to measure the thickness of the first two layers of the 

carotid artery wall. The FDA-cleared procedure determines 

whether there has been a build-up of fats causing the wall 

to thicken. Wall thickening is the earliest noninvasive indicator 

of atherosclerosis – the underlying cause of heart 

attack and stroke. The test provides the “age” of a patient’s 

arteries based on CIMT, compared to one’s chronological 

age. ArterioVision is quick and painless, and does not 

expose patients to radiation. 

“For instance it can tell you if you have arteries the age 

of an 80-year-old,” Nardoni said. “It’s a real wake up call to 

a lot of patients.” 

The test has been FDA cleared and there are plans to 

get clearance to market the test in Europe. 

But perhaps one of the crowning achievements for the 

company is the fact that they are working with NASA again. 

The test is coming full circle, according to the company, 

and is poised to be used by NASA Johnson Space Center 

(JSC) to help clarify and monitor the cardiovascular health 

of the Center’s astronauts and trainees. NASA will use 

ArterioVision at JSC to monitor the cardiovascular health of 

astronauts as they train for flight missions. JSC hopes to 

use the ArterioVision test as a preventive medicine screening 

tool for its employees, as part of an integrated wellness 

exam aimed at keeping employees healthy, and thereby 

reducing costs from lost work days. 



83 



84 

New neurostimulation helps with 

treatment-resistant depression 



A neurosurgeon at the Medical University of South 

Carolina (Charleston) has reported positive results with a 

new neurosurgical procedure for treatment-resistant 

depression. A small study – just five patients – found that 

bilateral epidural prefrontal cortical stimulation (EpCS) was 

generally safe and provided significant improvement of 

depressive symptoms. 

Seven months after implantation, patients experienced 

an average 54.9% improvement based on the Hamilton 

Rating Scare for Depression and 60.1% on the Inventory of 

Depressive Symptoms Self Report. Three patients reached 

remission and one had a minor complication that required 

removal of the implants. 

“I came up with the idea because I’ve been researching 

brain stimulation for over a decade,” Ziad Nahas, MD, director 

of the Mood Disorders Program at MUSC and medical 

director of the Brain Stimulation Laboratory, told Medical 

Device Daily. “We focused on these two regions because 

they are part of a larger brain network critical in regulating 

mood. Both play complementary roles integrating emotional 

and cognitive experiences and offer a distinct opportunity 

for targeted antidepressant treatments.” 

In a study published in Biological Psychology, Nahas 

and his team reported that five patients were implanted 

with EpCS over the anterior frontal poles and the lateral 

prefrontal cortex bilaterally. Four separate paddle leads 

were then connected to two small generators surgically 

implanted in the upper chest area of the patient. They then 

individualized the treatment parameters for each patient to 

maximize the long-term antidepressant effects. They relied 

in part on input from the patients who signaled positive 

mood changes when first stimulated in the operating room. 

“In the OR, we tested for the first time the stimulation 

and showed that in the small group of patients, we had significant 

immediate changes in terms of reducing anxiety 

and sadness,” Nahas said. “A couple of patients voiced an 

immediate feeling of increased attention and clarity. One 

patient had no reaction in the OR at all. But it was exciting 

as well as surprising that we could change emotions right 

there in the OR.” 

Only the sickest patients were included in this study, 

those who failed to respond to several antidepressant 

treatments, including medications, psychotherapy, transcranial 

magnetic stimulation, vagus nerve stimulation or 

electroconvulsive therapy. 

Medtronic (Minneapolis) donated its SynergyPlus+ neurostimulation 

system for the experiments, although the 

company is taking no part in this study or Nahas’ research. 

The devices were set to periodically deliver electrical 


charges at intensities below the seizure threshold and they 

were never active at night. 

One of the unique aspects of this application of cortical 

stimulation is that Nahas and team are using the stimulation 

intermittently and repeatedly, rather than continuously. 

“The idea with this is that we would implant electrodes 

over areas involved in mood regulation and stimulate 

intermittently so we could, over time, improve depressive 

symptoms,” he said. “By using repeated and intermittent 

stimulation, we could try to push the brain to adapt and 

change its function to have a better role at sustaining 

response. So one of the most critical elements in what we 

did, aside form the site targets, was that we also chose to 

go in not in a continuous mode of stimulation, but to got 

with intermittent cycles to not only bank on the immediate 

effect, but to help the brain choose to adapt to . . . a new 

homeostasis.” 

Nahas said this therapy is probably safer than deep 

brain stimulation because electrodes aren’t inserted deep 

into brain tissue, which avoids any potential for brain damage. 

Although the current study reports on seven-month 

data, Nahas has been following the patients for 1.5 years. He 

said that three out of the five patients had a recurrence of 

symptoms, but “It was fairly different from previous 

episodes. Their recurrence was short lived, whereas prior 

to having the implanted device, their average depressive 

episode lasted two-plus years.” 

He will continue to follow the patients indefinitely as 

he now seeks grant money to scale up for a larger trial. 

The average battery life for the SynergyPlus+ runs 

between one and four years, depending on usage. Nahas 

said he’ll advocate for replacement batteries down the road 

as needed, assuming these participants continue to reap 

benefits and remain depression free. 






Micrus, Flexible in j-v to make 

cranial aneurysm therapy 



Micrus Endovascular (San Jose, California) and 

Flexible Stenting Solutions (Eatontown, New Jersey) 

have partnered to develop a flow diversion technology to 

treat certain types of aneurysms. 

Flow diversion is a fairly new approach in the treatment 

of large and giant aneurysms, which represent 15% to 20% 

of treated intracranial aneurysms. 

Robert Stern, president/chief operating officer, told 

Medical Device Daily that, “We’ve been discussing publicly 

the need for potential flow diverter devices for three years. 

We’ve been looking at these technologies for longer than 

that. There are larger form aneurysms that need a treatment 

paradigm that’s more advanced than coils. Coils are 

very safe and effective. These devices would be used in 

complicated cases. It’s for a small subset of all aneurysm 

cases.” 

Treatment of aneurysms – a weak spot on a blood vessel 

in the brain that bulges out and fills with blood – can 

involve the use of tiny coils that fill the aneurysm sac, eliminating 

it from the cerebral circulation in a less invasive 

manner. But flow diversion is an even newer approach in 

which stent-like devices are placed in the parent vessel. 

They serve to divert blood flow away from the aneurysm so 

that it can heal. 

A patient who needs treatment for an aneurysm is typically 

evaluated to determine if the bulge should be clipped 

surgically or if an endovascular procedure is warranted, 

one that coils the lesion. Micrus already makes a MicroCoil 

delivery system. 

“If you think of a pipeline that has in the middle a softening 

of the walls,” he said. “Those walls bulge outward, 

weaken and you get this hideous bump. What you want to 

do is bypass the bulging segment with a flow diverter. It 

takes the pressure off the vessel wall in that section and 

allows for the safe diversion of flow, giving you another 

opportunity to treat this. In the past they stented across 

and put coils in. In some cases, we still may need to use 

coils.” 

What Flexible Stenting brings to the table is technology 

that facilitates this flow diversion technique. 

“If you have an outward-bulging or inward-bulging vasculature, 

the right-handed and left-handed design made by 

Flexible Stenting may bring unique flow diversion properties 

to the table,” he said. “It’s a very flexible design and 

should give us good wall coverage.” 

In the new deal, Micrus will handle the regulatory and 

clinical processes and will manufacture neurovascular 

products that emerge from this collaborative agreement. 

The new Flexible Stenting Solutions platform will 

85 

include a self-expanding stent design that will provide 

more accuracy in delivery; porosity and flow diversion control 

based on a unique design pattern; increased flexibility 

during delivery and post-placement vessel conformability; 

allow for post-placement coiling if necessary; and includes 

a special coating that is intended to reduce the potential for 

thrombogenicity and stenosis. 

John Kilcoyne, chairman/CEO of Micrus Endovascular, 

said, “We expect that our jointly developed technology will 

be used to treat wide-neck and fusiform aneurysms, as well 

as other types of clinical situations that currently are not 

adequately treated with either surgical or endovascular 

techniques.” 

Stern declined to review specifics about the deal, but 

did say that, “We will make an up-front licensing payment 

and payments based on certain milestones such as 

European CE mark and FDA clearance. Flexible Stenting 

Solutions will earn a royalty on everything we sell.” 

Stern declined to project a development timeline other 

than to say the platform is already developed and now 

must be optimized. 





86 

Molecular Detection prepares 

to launch quick MRSA test 



Molecular Detection (MDI; Wayne, Pennsylvania), a 

new player in the molecular diagnostics field, is preparing 

to launch the Detect-Ready assay for the rapid detection of 

methicillin-resistant Staphylococcus aureus (MRSA) as it 

just completed a $3.3 million Series C financing. 

The company purports advantages of its test that offer 

a quicker, more streamlined process with kits that are both 

preloaded with a gel containing all of the chemicals 

required for DNA-probe testing and the ability to deliver 

the product at room temperature. 

To date, the most widely used test to check for MRSA, a 

staph infection that’s resistant to common antibiotics, is a 

culture that can take one to two days. MDI’s test will produce 

results in under two hours. 

“Like the culture tests, we also are a nasal swab-based 

kit, but we’re really moving to an off-the-shelf test that 

changes the paradigm,” MDI CEO Todd Wallach told Medical 

Device Daily. “This uses PCR and gene amplification in a 

rapid fashion. We can detect very low samples of MRSA.” 

MDI is preparing to submit a 510(k) application to the 

FDA, but has already obtained CE mark in Europe for the 

Detect-Ready assays which is where the product will be 

launched first. 

It was both the near-term promise of MDI’s MRSA assay 

and the company’s potential with other molecular diagnostics 

that contributed to MentorTech Ventures’ decision to 

lead the Series C financing, according to Boris Kalandar, 

managing director of MentorTech Ventures and a board 

member of MDI. “The fact that the financing was significantly 

oversubscribed in a challenging market attests to 

investors’ enthusiasm for MDI’s approach.” 

Wallach was also just named CEO of this two-year-old 

company, spun out of Syntezza Bioscience (Jerusalem). But 

now MDI is to be the parent company while Syntezza will 

become the subsidiary, focused on R&D. 

“We anticipate launching the Detect-Ready assay for 

MRSA test later this year in Europe,” Wallach said. “This 

Series C financing represents a major milestone for MDI, 

confirming the promise of our innovative molecular diagnostic 

technologies and our soon-to-be-launched assay for 

MRSA screening. The Detect-Ready MRSA assay offers 

healthcare providers a high-performance diagnostic with 

an unmatched combination of accuracy, speed, flexibility 

and cost-effectiveness, addressing a market that is expected 

to exceed $1 billion in annual revenues in the next few 

years. We are gratified at the strong investor response to 

this financing, which provides the resources needed to 

launch our MRSA assay in Europe and the U.S. while also 

expanding our pipeline of molecular diagnostic tests.” 


In addition to MentorTech Ventures as lead for the offering, 

which was more than 300% oversubscribed, other 

investors included Ben Franklin Technology Partners, Robin 

Hood Ventures and the Mid-Atlantic Angel Group Fund I and II. 

MDI was previously funded by private investors and 

the company’s founders. 

Wallach just joined MDI after being CFO at Aton Pharma 

(Lawrenceville, New Jersey). 

The founder and president of MDI’s Israeli subsidiary, 

Aryeh Gassel, PhD, noted that the completion of the financing 

along with recruiting Wallach marks a turning point for 

the young company from development to commercialization. 

The staph infection test is expected to be a game 

changer because it’s easier to use and doesn’t require 

refrigeration. 

“There are other MRSA tests on the marketplace,” 

Wallach said. “But we believe the current tests require lots 

of preparation and work. Our test is designed to be [used] 

off the shelf. We will minimize operator and technician 

time,” he said, adding that the price will be competitive with 

others on the market. 

“It’s important to note our final confirmatory clinical 

studies are ongoing,” Wallach said, adding that those data 

will be available when the company submits its 510(k) application. 






Nanosphere submits 510(k) 

for rapid, POC influenza test 



If FDA cleared, Nanosphere’s (Northbrook, Illinois) 

new respiratory test to run on the Verigene SP may offer the 

kind of point-of-care diagnostic needed for a potential H1N1 

pandemic. 

The company this week submitted a 510(k) application 

to the FDA for its influenza and respiratory syncytial virus 

(RSV) test to run on the Verigene SP, with complete sampleto-result 

automation in one device, avoiding the need for 

complex PCR testing and reference labs. 

“The technology is based on gold nanoparticles that 

are turned into probes by functionalizing the surface of 

them with oligonucleotides,” William Moffitt, Nanosphere’s 

president/CEO told Medical Device Daily. “As it turns out 

these gold nanoparticles exhibit an extraordinary degree 

of specificity. It’s cost effective and easy to use. All of this 

can be packaged into a single-use disposable test cartridge. 

The only thing the user needs to do is to put the sample in, 

which is a nasal swab or nasal wash.” 

Verigene is a random-access, molecular diagnostic 

workstation for nucleic acid and protein diagnostics, and is 

FDA-cleared for in vitro diagnostic (IVD) use with specific 

Verigene tests. Verigene SP is a newer version of the benchtop 

workstation that provides automated sample-to-result 

molecular diagnostics capabilities in a multiplexed, random-access, 

modular system using the same imaging technology 

as the first generation Verigene. 

“The most important thing is the sample-to-result feature 

in one instrument,” Moffitt said. “And it’s random 

access, so there’s no batch processing. Most other assays 

on the market are batch-processed with a significant number 

of steps. It’s just not cost effective to go to that effort 

for one assay. But with Verigene SP you can run one assay 

as inexpensively as you can run 100. 

“Think about taking a PCR-based reaction and multiplexing 

it,” he said. “That’s what the industry has been 

doing. You’ve got to go to some post-PCR device to multiplex. 

But those probes lack a degree of specificity inherent 

in gold nanoparticles.” 

The test takes about three hours to produce results, 

but Moffitt said the company is continuing to shorten that 

time frame. 

The respiratory assay just submitted for FDA review is 

designed to test for all sub strains of flu, including detection 

of H1N1, “But we can’t make that claim until FDA clears 

it,” he said. 

When asked if Nanosphere requested an expedited 

review of the new assay given the looming H1N1 pandemic, 

Moffitt said, “You can request an expedited review, but my 

experience is that they are treating all of them (tests for flu) 

as expedited reviews because of the potential for a flu pandemic.” 

With its commercialization of Verigene SP and the new 

respiratory assay, Nanosphere is doing more than introducing 

just another quick test – it’s attempting to alter the 

molecular testing landscape and offer a test that rivals PCR 

accuracy, but at point of care. 

“If you think about a central hospital-based lab today 

and the kinds of tests they run and the rest of services in 

that hospital, the systems are highly centralized. In general 

molecular testing has been highly centralized and it needs 

to be decentralized into the average community hospital,” 

Moffitt said. “These molecular diagnostic labs are highly 

complex, but the market would benefit from a technology 

that’s simple and can be decentralized.” 

As it stands now, a regional medical center may include 

a half a dozen clinics or more. Given a flu pandemic, the 

samples would have to be taken at clinics and then transported 

to the hospital labs to be run later or the next day. 

“A diagnosis would have to be made in absence of that 

information,” he said. “The Verigene system has simplicity 

of operation and you could put these systems in those clinics. 

It would move molecular diagnostics closer to patients 

and move infectious disease assays to point of care for 

more timely diagnoses.” 

If the FDA grants clearance, Moffitt said the company 

will turn to the task of gearing up production for instruments 

and test cartridges. He declined to provide production 

estimates or turnaround if the world faced an H1N1 crisis. 

“It would be a reasonably short time frame, adding staff 

and shifts of labor for production processes,” he said. 

Verigene SP is priced at $20,000 and sample processing 

modules can be purchased individually. After being on 

the market for just two years in the U.S., Moffitt said no 

units have required replacement and he estimated the 

machines would last for “years.” 



87 



88 

Attendees at meeting enjoy 

its targeted, intimate setting 

By HOLLAND JOHNSON 

Medical Device Daily Managing Editor 

SAN FRANCISCO — While much of the action in town 

this week was down the street at the packed J.P. Morgan 

Healthcare conference, only a block up Powell Street at the 

Sir Francis Drake Hotel, the OneMedPlace Finance Forum 

gave attendees a glimpse at some private and smaller public 

companies that are on the cutting edge of medicine, and 

in a much more intimate setting. 

Attempting to bring to market a product to improve the 

surgical repair of mitral valve regurgitation is a company 

called Neochord (Minnetonka, Minnesota). John Seaberg, 

the company’s president/CEO said the company has developed 

a device that eliminates the need for a sternotomy 

and cardiopulmonary bypass. 

The company licensed the technology from the Mayo 

Clinic (Rochester, Minnesota) that was invented by a cardiac 

surgeon while in practice there. The tool is designed to 

allow for the use of minimally invasive use surgical techniques 

for the implantation of artificial chordae tendineae 

on a beating heart. 

During normal function, the chordae tendineae tether 

the mitral valve leaflets, ensuring correct closure during 

ventricular contraction. Rupture of the chordae due to 

myocardial infarction or degenerative disease is a common 

cause of mitral leaflet prolapse and subsequent mitral 

regurgitation. 

Seaberg said the company is currently looking for 

investors to top off a $3.5 million Series A round, the funds 

of which will be used to carry the company through the 

completion of its human feasibility trial which it intends to 

begin in May 2009. 

While the company plans to pursue those people who 

are already prime surgical candidates, Seaberg said 

NeoChord’s ultimate goal is to tap into the U.S. patient population 

of more than 2 million people with mitral regurgitation 

who have not been treated because the risks of the 

current procedure are currently deemed to be too high 

compared to the severity of their disease. These people, he 

said, are in need of a minimally invasive treatment option. 

“Current patients will be treated with less trauma, 

lower risk and less cost and frankly, that more patients will 

be treated because of the less invasive technology.” 

According to Seaberg, the clinical literature has shown 

that it is much better to treat patients in this sector while 

they are still relatively symptom-free. He noted that nearly 

42% of asymptomatic patients died from complications 

related to this disease within five years. “It is a silent killer,” 

he said. 

Seaberg said the company is hoping to have FDA 

approval for the technology sometime in 2012. 


Developing a photonic-based platform technology for 

the diagnosis and treatment of various diseases is 

InfraReDx (Burlington, Massachusetts). The private company 

is initially focusing on the creation of a system that 

will enable the diagnosis of lipid-core containing plaques in 

the coronary arteries. 

The company received FDA clearance for its catheterbased 

LipiScan coronary imaging system last April (Medical 

Device Daily, April 30, 2008). The LipiScan device uses nearinfrared 

(NIR) spectroscopy to identify lipid core containing 

plaques of interest in the coronary arteries in patients 

already undergoing cardiac catheterization. Such plaques, 

which cannot be detected by commonly used tests such as 

a treadmill exam and even coronary angiography, are suspected 

to be the cause of most sudden cardiac deaths and 

non-fatal heart attacks. This condition recently attracted 

heightened attention due to the death last June of Meet the 

Press host Tim Russert. 

James Muller, company founder and president/CEO 

said that NIR spectroscopy is used to measure the chemical 

composition of unknown substances. The LipiScan system 

uses optical technology, much of it developed for telecom 

uses, to deliver and retrieve NIR light from coronary 

plaques. 

Muller said the light reflected back at different wavelengths 

is analyzed to detect the chemical composition of 

the coronary plaques. At the completion of the catheter 

pullback, the LipiScan console instantly displays the scan 

results on a “chemogram,” a digital color-coded map of the 

location and intensity of lipid core containing plaques of 

interest in the artery. 

The company believes that the vulnerable plaque 

diagnostic market will exceed $2 billion by 2013. Muller 

said the company’s primary customers include interventional 

cardiologists, and its secondary market extends its 

reach to clinical research for drug and medical device 

development. 

According to Muller, the company is preparing a second 

generation of the device that can visualize and determine 

the chemical composition of lipid-rich plaques. 

InfraReDX has currently raised more than $87 million in 

private funds and is in the process of raising a $20 million 

C-2 round that Mueller said “will get us to financial 

breakeven.” 

Symphony Medical (Laguna Hills, California) is looking 

to treat heart failure, post-operative atrial fibrillation 

and other cardiac abnormalities with its biopolymer and 

biotherapeutic devices. 

The company’s CEO, Raymond Cohen, noted that the 

company’s goal is to deliver biocompatible polymers to 

specific areas of the heart during either open chest surgery 

or via a minimally invasive procedure. He said the biopolymers 

are engineered to achieve clinical benefit by locally 

modifying cardiac physiology. 

The company currently has two products in its late- 




89 

stage development pipeline. Algiysl-LVR is a treatment to 

prevent or reverse the progression of chronic heart failure 

and mitral regurgitation. The other product, Plexisyl-AF, is a 

prophylactic method of preventing sustained post-operative 

atrial fibrillation, a common side effect of the roughly I 

million coronary bypass and cardiac valve replacement 

surgeries performed each year. 

Cohen described how the company’s lead product, 

Algiysl-LVR, is delivered to achieve ventricular augmentation. 

He said the polymer is administered as an inert compound 

into the left ventricular wall of the heart where it 

reshapens and thickens the tissue. By restoring the shape 

of the ventricle from more of a “basketball shape to more of 

a football shape,” Cohen said pumping efficiency is reestablished 

and cardiac wall stress is also reduced. 

Essentially, the strategically placed biopolymer reconstructs 

the heart chamber so that it assumes its more natural, 

healthy form. Cohen said the implanted material does 

not cause negative immune reactions and it coexists permanently 

with the heart muscle. 

Cohen said the company is planning a first-in-man 

study of the Algiysl-LVR product sometime this quarter. The 

company filed an IDE for the product in December. The 

Plexisyl-AF product has advanced to human clinical trials, 

and a human clinical study was completed in Europe in May 

2008. The company plans to file an IDE for that product 

sometime this quarter, and a U.S. clinical study is planned 

for 2H09. 





90 

NeuroInterventions aims to 

deliver faster stroke care 



In the business world the old cliché is that “time is 

money.” In the world of stroke treatment, that expression 

becomes “time is brain,” – and it is the driving principal 

behind one early-stage company’s quest to speed up the 

delivery of post-stroke countermeasures in order to minimize 

brain damage. 

Michele Migliuolo, president/CEO of 

NeuroInterventions (NIT; Pittsburgh) described the 

development in a presentation at AdvaMed 2009 in 

Washington. He says the technology enables surgeons to 

reach and remove clots in much less time than conventional 

approaches. 

“When a patient stuffers a stroke – and by stroke I mean 

ischemic stroke – [there is a] time window of about nine 

hours in which something can be done to help that patient,” 

Migliuolo told Medical Device Daily. 

He noted that stroke is the third most frequent cause of 

death and the number-one cause of permanent disability. 

“Every second can mean a drop in brain function,” when a 

clot blocks the flow of oxygen-rich blood in the brain, 

Migliuolo said. 

“Even after a patient reaches a hospital, it can take up to 

60 minutes just to introduce a conventional catheter 

through the femoral artery and steer it to the site, before 

you can deal with the clot,” he said. 

According to NIT, its system, which is capable of dissolving 

or extracting clots and delivering medication, takes 

a shorter, faster path to the brain. With “exceptional maneuverability 

for negotiating the circulatory system,” the company 

said its devices “will benefit patients, physicians, hospitals 

and insurance companies by improving outcomes 

through shorter, more effective treatment; by permitting 

more complex procedures; and by reducing recovery 

times.” 

Migliuolo declined to explain to MDD how the patentpending 

technology works. However, he said that following 

his presentation at AdvaMed he was approached by three 

potential new investors who wanted to learn more about it. 

NIT says it is prototyping a family of patent-pending 

catheters for addressing deep vein thrombosis, carotid 

stenting, and traumatic brain injury, in addition to stroke. 

The technology also facilitates localized drug and stem cell 

delivery, the company noted. 

The company is hoping to begin testing its devices in 

animals in January or February of 2010, Migliuolo said. 

NIT says that three medical professionals who “realized 

that simpler and easier to use thrombectomy devices could 

potentially have a dramatic effect on patient outcomes” 

founded the company in December 2007. 


The company’s management team includes Lawrence 

Wechsler, MD, chair of the Department of Neurology and 

director of the Stroke Institute at the University of 

Pittsburgh Medical Center (UPMC); Mark Wholey, MD, 

founder and director of the Pittsburgh Vascular Institute; 

Tudor Jovin, MD, co-director of the Center for 

Neuroendovascular Therapy at the UPMC; Ender Finol, PhD, 

associate research professor for the Institute for Complex 

Engineered Systems and Biomedical Engineering 

Department at Carnegie Mellon University (Pittsburgh); and 

Migliuolo, a high-tech entrepreneur and former executive 

in residence at the Pittsburgh Life Sciences Greenhouse. 

Until recently the only FDA-approved drugs to treat 

ischemic stroke – Genentech’s (South San Francisco, 

California) tissue plasminogen activator (tPA) – had to be 

given within three hours after the onset of symptoms and 

the majority of patients miss that window of opportunity to 

receive the clot-busting drug. But in June the American 

Heart Association (Dallas) extended the tPA treatment window 

for stroke patients based on studies proving that the 

drug could be given to suitable candidates up to 4.5 hours 

after symptom onset. 

Still, several companies are working to widen the treatment 

window for ischemic stroke patients even more. Last 

year Penumbra (San Leandro, California) received FDA 

clearance for its Penumbra system – a drug-free approach 

that can be used up to eight hours after symptom onset. 

The Penumbra system is a package of tools used by 

neuro interventional specialists to remove occlusions from 

the large vessels of the brain that are causing an acute 

ischemic stroke. It works on the proximal surface of the 

occlusion, optimizing safety and eliminating the need for 

navigation beyond the occlusion, according to the company. 

The system is comprised of an aspiration platform containing 

multiple devices that are size-matched to the specific 

neurovascular anatomy allowing clots to be gently 

aspirated out of intracranial vessels. 

The Penumbra system is indicated for use in the revascularization 

of patients with acute ischemic stroke secondary 

to intracranial large vessel occlusive disease within 

eight hours of symptom onset. 

CoAxia (Maple Grove, Minnesota) also is trying to give 

ischemic stroke patients more time to get treatment with 

its NeuroFlo Perfusion Augmentation Therapy. Over the 

summer the company reported continued enrollment in its 

SENTIS pivotal trial of its NeuroFlo technology for acute 

ischemic stroke (MDD, June 24, 2009). The company said at 

that time that it had enrolled more than 75% of its goal of 

about 500 patients, with enrollment expected to conclude 

in early 2010, and PMA submission later that year. The company 

also reported then that it had completed two pilot 

studies of its NeuroFlo catheter in additional stroke patient 

populations – those treated as late as 24 hours after stroke 

onset and those who received NeuroFlo treatment in conjunction 

with intravenous tPA. 




91 

Another competitor in the ischemic stroke market is 

Concentric Medical (Mountain View, California), a company 

that originally received FDA approval for its Mechanical 

Embolus Removal in Cerebral Ischemia Retriever (Merci) 

device in 2004. The device is a catheter that contains a 

corkscrew-like wire designed to snare clots and pluck them 

from the artery. Concentric launched its third-generation of 

Merci retrievers, the V series, last year. 





92 

New breast cancer marker may 

predict likelihood of spreading 




If cancer doctors had a crystal ball they could peer into 

and know whether or not a particular patient’s cancer will 

spread, it would take the guesswork out of choosing which 

treatment option is best. 

For now, the next-best thing may be the discovery of a 

new breast cancer marker associated with metastasis that 

may lead to the development of a tissue test to predict the 

likelihood of metastasis via the bloodstream. 

In a small, case-control study, researchers at NewYork- 

Presbyterian Hospital/Weill Cornell Medical Center 

(New York) have linked the density of the new marker, 

called Tumor Microenvironment of Metastasis (TMEM), with 

the development of distant organ metastasis via the bloodstream. 

According to the authors, that is the most common 

cause of death from breast cancer. They also noted that 

about 40% of breast cancer patients relapse and develop 

metastatic disease and that roughly 40,000 women die of 

metastatic breast cancer every year. 

“Currently, anyone with a breast cancer diagnosis fears 

the worst – that the cancer will spread and threaten their 

lives. A tissue test for metastatic risk could alleviate those 

worries, and prevent toxic and costly measures like radiation 

and chemotherapy,” says senior author Joan Jones, MD, 

professor of clinical pathology and laboratory medicine at 

Weill Cornell Medical College and director of Anatomic 

Pathology at NewYork-Presbyterian Hospital/Weill Cornell 

Medical Center. 

In the study, investigators performed a retrospective 

analysis of tissue samples from 30 patients with invasive 

ductal carcinoma of the breast who developed systemic, 

distant-organ metastases. These samples were compared 

to matched controls that had breast cancer that did not 

spread. The samples were compared by size of the tumor, 

differentiation of the tumor (how it looks under a microscope 

compared to normal breast tissue), and other factors, 

Jones told Medical Device Daily. All patients were female 

and underwent primary resection of their breast cancer at 

NewYork-Presbyterian Hospital/Weill Cornell Medical 

Center between 1992 and 2003. 

The researchers found that TMEM density was more 

than double in the group of patients who developed systematic 

metastases compared with the patients with only 

localized breast cancer. Also, they found that in well-differentiated 

tumors, where the outcome is generally good, the 

TMEM count was low. 

“If patients can be better classified as either low risk or 

high risk for metastasis, therapies can be custom tailored 

to patients, preventing over-treatment or under-treatment 

of the disease,” said first author Brian Robinson, MD, resident 

in Anatomic Pathology at NewYork-Presbyterian 

Hospital/Weill Cornell Medical Center. 

The Integrative Cancer Biology Program of the National 

Cancer Institute funded the study. Because the analysis was 

done on a very select group of patients, Jones said the findings 

would have to be validated in a larger sample group 

before the test could be rolled out. 

“What we need to do next, before we could make this a 

more generally applicable test, is we need to do a population 

study . . . using a much broader range of subjects,” 

Jones said. “So we’re trying to get funding to do that and get 

a bunch more people – a few hundred, lets say – so we can 

see if what we observed in these select patient samples 

[can be made] more general.” 

The Weill Cornell investigators set out to build on previous 

research by co-author John Condeelis, PhD, of the 

Albert Einstein College of Medicine (Bronx, New York). 

Working in animal models, he identified a link between 

blood-borne or systemic metastasis and a three-part association 

between invasive carcinoma cells, perivascular 

white blood cells (macrophages) and the endothelial cells 

that line vessel walls. To confirm this finding in humans, 

Jones and Robinson developed a triple immunostain for 

human breast cancer samples that simultaneously labels 

the three cell types that together they named TMEM. 

“What made us try this in the human samples is what 

had been observed in some of the animal models of breast 

cancer,” Jones said. 

In some of the animal models scientists have been able 

to actually look at the tumor in the live animal and watch 

cells move in the vessels. 

Jones admitted that the fact that this test did seem to 

work in the case-control study was somewhat surprising to 

her. 

“This is a very novel way for a pathologist like me to 

look at tissue,” she tells MDD. “It’s not intuitive, it is kind of 

a new concept.” 

Jones said that before she and her colleagues did the 

case-control study, they had analyzed “a bunch of breast 

cancers” and stained them and looked for these TMEM 

structures and counted them. In those tumors where the 

outcome was moderate or poor, the researchers counted a 

higher number of the TMEMs. “That encouraged us to think, 

‘well maybe this means something,’” she said. 

Likewise, in the case-control study, the cancers that 

metastasized had a higher number of TMEMs than the cancers 

that did not spread. “It did seem to have some reflection 

of that tumor’s ability to get into blood vessels,” Jones 

said. 

Notably, Jones said TMEM density was associated with 

the development of distant-organ metastasis, independent 

of lymph node status and tumor grade. 

“Traditionally, the likelihood of breast cancer metastasis 

is estimated based on tumor size, tumor differentiation 

– how similar or dissimilar the tumor is compared to nor- 




93 

mal breast tissue – and whether it has spread to the lymph 

nodes. While these are useful measures, TMEM density 

directly reflects the blood-borne mechanism of metastasis, 

and therefore may prove to be more specific and directly 

relevant,” Jones said. 

In addition to validating the findings in a larger sample 

group, the researchers say they need to identify a threshold 

TMEM density for metastasis risk, and streamline the 

process for measuring TMEM. 

While an estimated 10% to 15% of patients have an 

aggressive form of the disease that metastasizes within 

three years after initial diagnosis, metastasis can take 10 

years or longer to occur, the authors noted. To decrease the 

risk for the emergence of metastatic tumors, roughly 80% 

of breast cancer patients are treated with adjuvant 

chemotherapy. The clinical benefit is a 3% to 10% increase in 

15-year survival, depending upon the age of the patient at 

diagnosis, according to the study authors. 

“A lot of patients are getting chemotherapy because 

there could be some chance that they’re going to metastasize, 

but they don’t really know what that risk is,” Jones said. 

Study co-authors include Gabriel Sica, MD, PhD, and Yi- 

Fang Liu, MD, of NewYork-Presbyterian/Weill Cornell; 

Thomas Rohan, MD, PhD, of the Department of 

Epidemiology and Population Health at Albert Einstein 

College of Medicine; Frank Gertler, PhD, of the Department 

of Biology, Koch Institute for Integrative Cancer Biology at 

Massachusetts Institute of Technology (Cambridge); and 

Condeelis of the Department of Anatomy & Structural 

Biology, Program in Tumor Microenvironment and 

Metastasis, Albert Einstein Cancer Center at the Albert 

Einstein College of Medicine. 





94 

NIH scientists develop rapid 

test for Sjögren’s syndrome 



The autoimmune disease known as Sjögren’s syndrome 

can cause a wide-ranging list of ill effects from irritating 

to life-threatening. Current tests usually diagnose 

the condition only about half the time, adding to treatment 

complications. 

Scientists at the National Institute of Dental and 

Craniofacial Research (NIDCR), part of the National 

Institutes of Health, are in the process of developing a 

rapid, automated test that correctly diagnoses the syndrome 

three out of four times and with strong accuracy. 

“We’ve developed a new technology; no one else has 

done this. We’ve built a large panel of tests for autoimmune 

targets,” Peter Burbelo, PhD, a scientist at NIDCR heading up 

the research, told Medical Device Daily. 

Burbelo is referring to luciferase immunoprecipitation 

system (LIPS), which uses mammalian cell-produced recombinant 

antigens for analyzing Sjögren’s autoantibody 

responses. 

Currently doctors test for two antibodies that are often 

associated with the condition, but these blood tests tend to 

detect the more strongly associated antibody, called SSB. 

But it works only about 45% of the time. 

“We found that our assay picked up 75% of SSB antibody,” 

he said. It also identifies a second related antibody, 

called SSA. 

Sjögren’s causes the immune system to turn against 

the body’s own cells, commonly affecting the glands that 

produce saliva and tears. But the disease can attack more 

than that, manifesting in joint inflammation, various types 

of autoimmune thyroid, kidney, liver, lung, and skin diseases, 

and changes in nerve function of the upper or lower 

limbs. Some people with Sjögren’s are also more prone to 

develop lymphoma. 

In addition to using current blood tests, physicians typically 

opt to biopsy a salivary gland to see if there’s an 

inflammatory attack. 

LIPS would avoid the need for biopsies and offer a rapid 

diagnosis from a reference lab. But Burbelo envisions that 

the test could eventually be developed for point-of-care 

use. 

LIPS is a traditional assay in which an antigen, or segment 

of a protein known to elicit an antibody response, is 

fused to an enzyme similar to the light-producing 

luciferase that produces the flash in fireflies. 

“The antigen binds to what I’ll call the flashlight protein,” 

he said. “We capture those antibodies. If they glow, it 

means you have antibodies to the target.” 

The greater the intensity of the light flash, the more 

target antibody there is bound to the antigen. 


But what makes LIPS different from other assays is its 

sensitivity. 

In his team’s most recent work, reported in the current 

issue of Autoimmunity, Burbelo and colleagues used the 

test on 82 people, 57 of whom had well-characterized primary 

Sjögren’s syndrome. 

They reported that 42 of the study’s 57 patients had 

antibody reactions against a segment of the Ro52 antigen 

that does not elicit a response in currently used ELISA tests, 

a sign of the LIPS assay’s greater sensitivity, he said. 

LIPS was able to detect antibody responses against 

each protein in about 60% of cases, equal to an ELISA, but 

with greater specificity. They also tested for other conditions 

that aren’t usually linked to Sjögren’s syndrome, but 

are anecdotally reported by patients. 

“We hypothesized that if we made antigens for the thyroid, 

stomach and peripheral nervous system, LIPS could 

pick out the subset of patients with antibodies against 

these tissues,” said Mike Iadarola, PhD, another NIDCR scientist 

and senior author on the study. 

The researchers discovered that 14% of the patients had 

antibodies against the thyroid antigen, 16% had antibodies 

against an antigen associated with autoimmune gastritis 

and 4% had antibodies linked to an autoimmune attack of 

the eye’s peripheral nerve. 

Burbelo said this aspect of the test will go a long way in 

terms of helping physicians to diagnose the disease in 

patients that present with a set of symptoms that aren’t 

commonly assumed to be a result of Sjögren’s syndrome. It 

also opens the door to further study the disease and how it 

affects the entire body, beyond the salivary and tear glands. 

The test will require further refinement before it’s 

ready to commercialize. 

“It’s not ready for prime time in the sense that we don’t 

have a commercial developer,” he said, adding that his team 

is busy developing LIPS for applications in other autoimmune 

diseases. “We’re still trying to build more tests and 

trying to find new biomarkers for diseases where there 

aren’t any, like fibromyalgia.” 






NiTi introduces new closure 

device for colorectal surgery 

95 



For about the last 30 years, anytime a patient has colorectal 

surgery, either for cancer or for inflammatory diseases 

like ulcerative colitis, they have to worry about certain 

risks associated with the post-operative healing 

process due to the use of surgical staples, which can crush 

and puncture tissue. Leakage, inflammation, infection, and 

bleeding are the primary concerns with this method of 

bowel closure. 

But a new staple-free closure device recently launched 

in the U.S. for colorectal surgery could introduce colorectal 

surgeons to a way of joining two segments of bowel that is 

very different from what’s been done for the last three 

decades. According to NiTi Surgical Solutions (Netanya, 

Israel/Chesterfield, Missouri), the ColonRing is designed to 

help the patient’s body heal naturally after this type of surgery. 

NiTi says the FDA-cleared, CE-marked ColonRing represents 

the first major advancement in this area in more than 

30 years and could address the major drawbacks of staples. 

NiTi CEO Itay Itzhaky told Medical Device Daily that for 

the past three decades, two device companies have controlled 

the colorectal closure space – US Surgical (now 

Covidien; Mansfield, Massachusetts) and Ethicon Endo- 

Surgery (Cincinnati), a business of Johnson & Johnson (New 

Brunswick, New Jersey). In fact, he said more than 95% of 

staplers used worldwide have been sold by one of those 

two companies. 

There are two types of staplers, Itzhaky noted, circular 

staplers, which are commonly used for colon and 

esophageal surgery, and linear staplers, which are more 

commonly used in the small bowel and gastric applications. 

The major problem with using staples for bowel operations 

is leakage which Itzhaky said can be quite dangerous 

– even life threatening – because spillover from the bowel 

can lead to infection. He said the leakage rate can be up to 

25% depending on what part of the bowel has been operated 

on. Of course there is also the risk of bleeding, he said, 

which occurs between 4% and 8% of the time, depending on 

what part of the bowel it is – the bleeding rate is much 

higher when staples are used in the small bowel, he noted. 

“What we are trying to use in our product is actually 

BioDynamix technology relying on compression,” Itzhaky 

told MDD. Because NiTi’s colon ring is staple-free, there are 

no bowel wall punctures, no risk of staple line bleeding, 

and no permanent foreign bodies in the bowel as can happen 

with surgical staples, Itzhaky said. In the ColonRing, 

the Nitinol leaf springs stretch to open the ring for placement 

in the bowel, and then gradually return to their original 

closed position, adapting to variations in tissue thickness, 

and accommodating compressed tissue, the company 

said. The nitinol leaf springs continuously apply force 

range of pressure around the full circumference of the 

anastomosis (the surgical connection of two parts of a hollow 

organ). As the compression progresses over several 

days, the tissue trapped within the ring becomes necrotic, 

while healthy tissue is generated along the ring’s outer 

perimeter, according to NiTi. Itzhaky said the device is 

expelled out of the body between seven and 14 days. 

NiTi said the ColonRing is designed for anastomoses 

throughout the alimentary tract for the creation of end-toend, 

and end-to-side anastomoses in both open and laparoscopic 

surgeries. The device is a sterile, single-patient, single-use 

device, the company noted. 

According to the company, more than 500,000 surgeries 

involving GI tract resection are performed in the U.S. 

each year. The ColonRing is comprised of nitinol, a metal 

alloy that contains nickel and titanium. Nitinol exhibits 

“shape memory” the company said. The ColonRing is 

placed in cold water prior to surgery – and once implanted, 

the patient’s body heat causes the Nitinol to return to its 

original shape, which is what encourages the natural surgical 

connection of the two parts of the bowel. 

Itzhaky said NiTi is taking advantage of one special 

quality of nitinol – its ability to force enhancement on tissue 

and the ability to be able to control the exact force you 

need to help the body to heal itself naturally. That makes 

the healing process safer and reduces the leakage rates 

and other risks that occur with the stapling method. 

Itzhaky told MDD that since the ColonRing has been 

available in the U.S., the vast majority of doctors who perform 

colorectal surgeries have been willing to try the 

device because the concept of compression of anastomosis 

is something they were already familiar with; they just didn’t 

have the tool to do it until now. 

NiTi also has another product in its pipeline, the Hand 

Compression Anastomosis Clip (CAC) 30 for side-to-side 

and end-to-side anastomeoses. The Hand CAC 30, a palmsized 

applier instrument, is designed for colorectal, gastric 

and upper GI surgeries, NiTi said. The design and “excellent 

maneuvering capability” advances open and hand-assisted 

laparoscopic surgery (HALS) techniques, according to the 

company. Like the ColonRing, the Hand CAC 30 is also a 

sterile, single-patient, single-use device, and is also FDAcleared 

and CE-marked. 





96 

NovoCure brain cancer device 

gets backing from big pharmas 



Privately held NovoCure (Haifa, Israel) is taking its 

cancer treatment device into a pivotal trial – squaring off 

against one of the most aggressive cancers: glioblastoma 

multiforme (GBM), the brain cancer that generally kills its 

victims in about a year. 

Apparently the early data are so promising that some 

heavyweight backers are now on board. The company just 

reported completing a new funding round with investors 

Pfizer (New York), Johnson & Johnson (New Brunswick, 

New Jersey) and Index Ventures. 

“We’re very happy to have them on our team of 

investors,” Mike Ambrogi, U.S. general manager for 

NovaCure, told Medical Device Daily. “Prior to this fundraising 

round they weren’t involved. Both companies have vast 

experience and we look forward to their input, but they are 

not directly involved in R&D. But we have the opportunity 

to draw upon their counsel.” 

NovoCure’s pilot study in Europe, which was the basis 

for its investigational device exemption approval, included 

10 patients, of whom seven are still alive today, five years 

out. 

“If all of the patients were to expire now, we would have 

median overall survival of 62 months vs. 14.6 months for 

temozolomide (chemotherapy) alone,” Ambrogi said. “We 

continue to follow these patients and they continue to live. 

Five of 10 are progression free, meaning there’s been no 

recurrence and they aren’t on any treatment of any kind.” 

Although the amount of the investment that came from 

the pharma giants was undisclosed, Ambrogi said it’s 

enough to get the company’s promising treatment through 

trials and, if all goes well, into commercialization. 

The Novo-TTF device aims to zap solid tumors via specially 

tuned, low-intensity electrical fields known as tumor 

treating fields (TTF) to disrupt cell division. Rapidly dividing 

cancer cells are either broken apart or fail to divide 

properly when attacked by these electrical fields. Healthy 

surrounding cells aren’t affected, yielding a targeted treatment 

with minimal side effects. 

“To date, the only known side effect is a reddening of 

skin, dermatitis, where the electrodes are attached, which 

is to be understood, given that it’s warm and moist,” 

Ambrogi said. “Other than that, no adverse events have 

been attributed to the device.” 

The patient wears a cap on the scalp that’s embedded 

with non-invasive, insulated electrodes. Those electrodes, 

which look like bandages, are attached by wires to a battery 

operated, six-pound portable device – carried in an 

over-the-shoulder satchel – that generates the fields. 

Patients wear the cap for up to 24 hours a day 


In the new 283-patient trial, investigators will study the 

efficacy of the Novo-TTF device for newly diagnosed GBM 

patients in combination with standard-of-care chemotherapy, 

temozolomide (made by Schering-Plough [Kenilworth, 

New Jersey]), compared with chemotherapy alone in 

patients with newly-diagnosed GBM. Two-thirds of the 

patients will receive treatment with the Novo-TTF device 

while the rest will receive only chemotherapy. 

“The primary endpoint is progression-free survival 

time,” Ambrogi said. “We are also expecting to show overall 

survival benefit.” 

Study centers are now enrolling patients in the U.S., 

Europe and Israel. The trial is expected to last two years 

with a one-year follow-up. If all goes well, the company will 

be ready for a PMA submission in 2012. 

NovoCure also recently completed enrollment for a 

236-patient, multi-center, randomized pivotal trial studying 

the safety and efficacy of the Novo-TTF device treating 

patients with recurrent GBM compared to standard-of-care 

chemotherapy. Ambrogi pointed out that patients with 

newly diagnosed and recurrent GBM are treated quite differently, 

hence the separate trials. The results of this trial 

will be presented to the FDA as part of a PMA application 

planned for early next year. 

“The way the tumor reacts is different in newly diagnosed 

GBM vs. recurrent,” he pointed out. “Typically newly 

diagnosed patients have minimal disease. In recurrent 

cases the tumor is potentially more aggressive and 

responds differently to treatment.” 

The company’s device was invented by NovoCure’s 

founder, Yoram Palti, MD, PhD, who began testing the technology 

in the basement of his home more than a decade 

ago. “He theorized how it could work and then verified it in 

the lab,” Ambrogi said. “We believe it’s a pretty strong platform.” 

That platform, he added, will be applicable to other 

cancers too. A small trial – 42 patients with non-small cell 

lung cancer is currently being conducted in Switzerland. 

“These are late-stage patients who failed first-line treatment,” 

Ambrogi said. “We’re seeing some promising early 

results.” 

But the company is focused on the GBM indication right 

now. “We started on brain cancer because it’s a pretty tall 

hurdle. Patients don’t have a lot of options. The prognosis 

for a GBM patient is fairly dire and we think we can have a 

pretty significant impact. We believe we can be successful 

and make a big difference to these particular patients,” he 

said. 

Ambrogi said he is not aware of any other company 

developing a device that uses alternating electric fields to 

arrest cell growth, making NovoCure a pioneer in this 

approach to cancer treatment. 






NMT Medical moves up timetable 

on Closure I Clinical Trial 

By OMAR FORD 


NMT Medical (Boston) is on the path to bringing its 

StarFlex device closer to the market. The company said that 

it will commence data analysis for its CLOSURE I clinical 

trial – originally scheduled for the fall of 2010 – in April 2010. 

The trial is evaluating StarFlex’s effectiveness in treating 

patent foramen ovale (PFO) stroke and transient ischemic 

attacks. 

Bumping up the time table stems from an independent 

group of statistical advisors determining that a significant 

number of primary outcome events will be demonstrated 

in both treatment arms of the trial and will have occurred 

by next month, according to NMT. 

The company added that by April 2010, the data is 

expected to have statistical power to support a primary 

outcome result and thus it would be scientifically appropriate 

to begin the analysis at that time. 

At that time the company said that 99.4% of all patient 

follow-up months will have been completed and 95.1% of 

patients will have completed the two-year follow-up. 

The results of the analysis are anticipated during 3Q10 

at which point the trial will be complete, with 100% of the 

randomized patient follow-up available. If the results prove 

positive for device closure, the company will be in a position 

to submit a PMA for its Starflex device for the stroke 

and TIA indication to FDA. 

“The Starflex is an implanted technology that is used 

through minimally invasive procedures to treat structural 

heart disease” NMT CFO Richard Davis told Medical Device 

Daily. “We’re going down the PMA approval [pathway].” 

CLOSURE I is the first clinical trial approved by the FDA 

that brings together stroke neurologists and cardiologists 

to compare two treatments for embolic stroke and determine 

which is the most effective. 

It is being led by Principal Investigators Anthony 

Furlan, MD, and Mark Reisman, MD. Furlan is Chairman, 

Department of Neurology, Neurological Institute University 

Hospitals Case Medical Center, and Case Western Reserve 

University School of Medicine (Cleveland). Reisman is 

Director, Cardiovascular Research and Director, Cardiac 

Catheterization Lab, Swedish Heart and Vascular Institute 

(Seattle). 

StarFlex will be compared against pharmaceutical 

treatments, in the trial, which will include 910 patients 

throughout more than 95 centers. Of the 910 stroke and TIA 

patients enrolled, half received treatment with NMT’s 

StarFlex implant and half were treated with drugs alone. 

Follow up for the device arm of the study will require 

patients to see the interventional cardiologist who implanted 

the STARFlex six months after the procedure. This visit 

97 

will involve a chest X-ray. Depending on the results of these 

tests, further visits may be required. 

Patients in the medical therapy arm taking warfarin will 

have to have their prothrombin (clotting time) rates 

checked weekly against international normalization ratios 

(INRs) until a therapeutic level of between 2 and 3 is established, 

then every month after that. This is a simple blood 

test measuring the number of seconds if takes for an individual’s 

blood to clot. Patients taking aspirin will not need 

any special testing. 

NMT’s President/CEO Frank Martin said, “Since completing 

enrollment in late 2008, we have worked closely 

with the CLOSURE I Executive Committee to address the 

delicate balance between the medical community`s desire 

for more effective treatment options and the value of maximizing 

the amount of data we will file with the FDA. 

Commencing the data review in April 2010 should allow 

NMT to submit a PMA during the third quarter of 2010, 

assuming a positive outcome.” 

If the results are less than favorable then the company 

would have to make adjustments. 

“I think that if you don’t hit the primary endpoint you 

have to analyze the results and then see where you go from 

there,” Davis said. 





98 

Nomir’s Noveon photo-biologically 

treats the toughest infections 



Phototherapy to treat infectious diseases isn’t new, but 

Nomir Medical Technologies (Waltham, Massachusetts) 

is on the verge of commercializing its Noveon dual-wavelength 

device, which photo-biologically targets the elimination 

of bacterial and fungal infections in a unique way, combining 

the therapy with some old reliable antibiotics to 

more effectively treat the toughest infections such as 

methicillin-resistant Staphylococcus aureus (MRSA). 

While most of the medical world working on infectious 

diseases is focused on new, stronger drugs for multi-drug 

resistant pathogens such as MRSA, Nomir has taken a very 

different tact by first photo-damaging the pathogens so 

that standard antibiotics can crush the infections. 

A study published in Photochemistry and Photobiology 

describes data that demonstrate how Noveon targets the 

elimination of bacterial and fungal infections through a 

unique, near-infrared (NIR), photo-inactivation effect, while 

preserving healthy tissue and promoting recovery. 

Combine that with standard antibiotics and this new-style 

device has the potential to successfully treat a slew of difficult 

infections such as those that occur around central 

venous catheters, dialysis port infections, chemotherapy 

port infections, diabetic food ulcers and pressure wounds. 

“With publication of this paper we have codified three 

to four years of data that show you can selectively damage 

pathogens without harming human tissues,” Eric Bornstein, 

DMD, chief scientist of Nomir and lead author on the paper, 


The company has submitted data to the FDA from a 

human pilot study to gain clearance for a first indication in 

onychomycosis (toenail fungus). The company will file 

another application early next year for diabetic foot ulcers. 

“We submitted the pivotal study for onychomycosis to 

the FDA in June,” Richard Burtt, president/CEO of Nomir told 

MDD. “We are in the final stages and expect clearance in 4Q 

2009. The Noveon system is in manufacturing now. We’re 

outsourcing manufacturing to two separate companies. 

Upon clearance they’ll be ready to roll out the product.” 

In the most recent onychomycosis study, all seven 

patients reached a mycological negative culture at 60 days 

following treatment. No adverse events were observed. 

Noveon has dual-wavelengths of 870 nm and 930 nm 

to decrease trans-membrane potentials, which are measures 

of the robustness of cellular bioenergetics and simultaneously 

increase in reactive oxygen species (ROS) in cells. 

In effect, the light-based therapy selectively damages 

pathogens. 

“What we do is to perturb the bioenergetics of the 

cells,” Bornstein said. “We inhibit the metabolic action of the 


cells, raising ROS. With this phenomenon, we’ve been able 

to photo-inactivate bacterial and fungal pathogens.” 

The current research paper reveals further information 

about the efficacy and side-effect profile of Noveon in multiple 

classes of infectious disease pathogens. 

Bornstein predicts Noveon will replace thermal eradication 

of fungus and bacteria as a more successful treatment 

option. 

In addition to replacing the standard treatment for onychomycosis, 

Lamisil, both Bornstein and Burtt said the 

device will have even greater future applications, particularly 

MRSA. 

He explained that MRSA is found in nasal passages. 

Surgical patients typically get the infection after touching 

their nose, or sneezing, and then touching the surgical site. 

“The only way to get rid of that today is with Bactroban, 

which 40% of MRSA is resistant to, or an infusion of vancomycin,” 

Bornstein. “If we can do this with six to seven 

treatments with Noveon and 2% erythromycin, we’re going 

a long way to cutting down the use of sophisticated antibiotics.” 

In essence, the treatment would roll back the need for 

the most powerful antibiotics and make use of old standbys 

such as erythromycin, tetracycline and penicillin in the 

fight against MRSA and other infections. 

“We believe Noveon will be first medical device cleared 

by the FDA for treatment of onychomycosis,” Burtt said. 

“But it’s intended to be a platform technology to treat bacterial 

and fungal infections. One system will be able to 

deliver many therapies for dermatologists and podiatrists.” 

Assuming FDA approval, commercialization will come 

without reimbursement for onychomycosis therapy. 

“For the time being, we will launch on a self-pay business 

model,” Burtt said. “But other applications, such as diabetic 

foot ulcers and hospital infections will be reimbursable.” 

Bornstein said no adverse events or side effects have 

been reported, mainly due to the selective aspect of NIR 

photo-inactivation. 

Results of in vitro studies have also demonstrated 

photo-inactivation of 98% of S. aureus colonies and of 97% 

of E. coli colonies, versus control, at physiologic temperatures. 

Additionally, complete photo-inactivation of 100% of 

T. rubrum and C. albicans colonies was achieved vs. control. 






Transplant medicine advances 

from a cooler of ice to LifePort 



Just as the new year begins, researchers have pushed 

open a massive door in the field of organ transplantation 

medicine that will offer expanded opportunities for more 

transplants with far better outcomes. 

A machine developed by Organ Recovery Systems 

(ORS; Chicago) that stores kidneys for transplant has been 

proven in a landmark study indicating an ability to vastly 

improve the survival and function of organs. This compares 

to the most common, and rudimentary, transport 

method currently available: a bag of ice in a cooler – or 

essentially the kind of treatment normally offered the standard 

six-pack of beer. 

The ORS technology has promising applications for 

liver, heart, pancreas and lung transplants too, according to 

the company. 

“Organ transplantation medicine has finally reached 

the 21st century,” David Kravitz, CEO of ORS told Medical 

Device Daily. 

So notable is this technology advance – an egg-shaped, 

20-pound device that’s about the size of a carry-on suitcase 

– that it has been added to the permanent collection of New 

York’s Museum of Modern Art. 

“We made it iconic-looking to make a statement in 

terms of the physicality of it – to set it apart from the box of 

ice,” Kravitz said. “But it’s built to be rugged because we 

knew it had to go as robustly anywhere that a box of ice 

would go, including being unattended in the cargo hold of 

an airplane.” 

The company’s LifePort Kidney Transporter was FDAapproved 

in 2003, but when ORS first received that 

approval, it didn’t have the financial guns to run a pivotal 

trial. 

Thus, the system has been used only on a pilot, introductory 

basis, to date. 

But a study published in the current issue of the New 

England Journal of Medicine now proves that use of the 

LifePort, which preserves a kidney by continuously pumping 

a temperature-controlled nutrient solution through the 

organ and monitors performance in real time, offers significant 

benefits in organ survival and function compared to 

those that are moved from donor to patient in an iced cooler. 

The international trial reported in the NEJM enrolled 

kidney pairs from 336 deceased donors in Europe and randomly 

assigned one kidney to machine perfusion and the 

other to static (ice) storage. Results showed that the odds 

of a delay in kidney function post-transplant were reduced 

by almost half when machine perfusion was used compared 

with static cold storage. 

99 

The study is considered a landmark because it’s the 

first randomized, prospective study to compare the two 

methods of storing and transporting organs. 

“We needed to set the story straight on the differences 

between our machine and bags of ice,” Kravitz said. 

Comparing the progress and development of the system 

to making a “movie,” he said it was shot “out of 

sequence, but it was really an artifact of funding. In this 

study, the investigators were trying to answer an age-old 

question in renal transplantation: does a machine improve 

the outcome of a transplant vs. a box of ice” 

Delay in function is a relatively common complication 

that affects the long-term outcome of kidney transplants. 

The study also proved that the LifePort kidneys were 48% 

less likely to fail within the first year, post-transplant, compared 

to those kidneys stored in the traditional box of ice 

prior to transplantation. 

“Delayed graft function is a term that defines a posttransplant 

episode where the kidney doesn’t immediately 

function and the patient must be dialyzed,” Kravitz said. 

“It’s painful, causes complications and involves longer hospital 

stays.” 

In the early days of transplantation medicine, the ideal 

donor was the young motorcycle accident victim, with a 

closed-head injury, whose organs were all healthy and 

intact, Kravitz explained. Older donors and those who 

weren’t as healthy weren’t even considered because of the 

possibility that their organs wouldn’t survive or wouldn’t 

perform well. 

“Over time, the donor community has grown, demand 

has grown dramatically, and the average donor has a 

broader definition of secondary medical conditions and 

age that can be considered,” Kravitz said. 

More than 1.5 million people worldwide suffer from 

end-stage renal disease, for which a kidney transplant is 

the best treatment option. The National Kidney Foundation 

(NKF; New York) reports that the number of those waiting 

for a transplant has passed 100,000. 

“Any new method like the one demonstrated in this 

study, that will help maximize the available organs and 

potentially reduce the need for re-transplantation, is vitally 

important for patients and the professionals who care for 

them,” said Joseph Vassalotti, MD, chief medical officer of 

NKF. 

Beyond kidneys, LifePort is considered to be a platform 

technology. 

“It was designed to be extended to other organ types 

without changing a whole lot,” Kravitz said. “We have latestage 

prototypes that have been evaluated in large mammal 

models. We’re considering in 2009 how to move them 

forward.” 

Although an exact commercial pricing model hasn’t yet 

been established, he estimated the cost of the base hardware 

at $15,000 to $20,000 per unit. Machine life expectancy 

is unknown, although the units that have been in pilot 



100 


use, now for four years, show no signs of wearing out. 

Training on how to use the LifePort is relatively easy: 

“An average-trained medical technician can learn how to 

use this in a few hours,” Kravitz said. 

ORS sub-contracts the manufacturing and anticipates 

full commercial launch in 2009, with a strong thrust first in 

the U.S. and Canada followed shortly after by launches in 

Europe (where CE mark was already obtained) and Brazil. 

(This story originally appeared in the January 5, 2009, 





New orthopedic device 

designed to be ‘steerable’ 


“Steerable” is a word several companies across the 

medical device industry use to describe their products. 

There are steerable guidewires, steerable catheters, and 

even a steerable pill camera designed as a diagnostic tool 

for the colon that uses a hand-held magnet as a control system 

(Medical Device Daily, June 25, 2008). 

Now the word steerable is being applied to technology 

used in arthroscopic procedures. OrthoDynamix 

(Jacksonville, Florida) this week introduced a new steerable 

device platform designed to address joint pain issues from 

sports injuries, genetic damage and pre-arthritis. 

According to the company, ArthroSteer “significantly 

improves access in hip and other arthroscopic procedures.” 

Arthroscopic procedures allow orthopedic surgeons to 

visualize, diagnose, and treat problems inside a joint. While 

it is a surgical procedure, it requires only small incisions 

therefore patients tend to recover more quickly and with 

less post-operative pain than with open surgery, according 

to the Arthroscopy Association of North America 

(Rosemary, Illinois). 

The ArthroSteer platform of disposable instrumentation 

includes four products that OrthoDynamix says allow 

surgeons to facilitate arthroscopy with a mulit-control 

device, and steer and reach around joint capsule structures 

while interacting with tissue that affords not just diagnosis 

but repair. 

“This is the first steerable device designed specifically 

for arthroscopy that can withstand the rigors of orthopedic 

surgery and that can deliver enabling technology for the 

repair of joint capsules,” said CEO Bill Dennis. “Since these 

devices greatly improve the access to joint capsules, 

specifically the hip, more surgeons will offer hip 

arthroscopy as an alternative for pre-arthritic injuries and 

congenital abnormalities.” 

While there are more than 1.5 million arthroscopic knee 

and shoulder procedures in the U.S. every year, according 

to OrthoDynamix, hip arthroscopy is very new, the company 

said. “This is a very exciting time since hip arthroscopy 

is helping people with hip pain stay active longer. 

Moreover, professional athletes can now even extend their 

careers. If surgery is done early enough, it can possibly prevent 

cartilage damage and arthritis,” Dennis said. 

According to OrthoDyanamix, surgeons are able to 

manipulate ArthroSteer instruments by three specific controls 

on the handle. While the jaw opens and closes, much 

like conventional surgical instruments, the flexible spine 

bends 180 degrees and the jaw rotates 360 degrees “like no 

other available instrument,” the company said. 

OrthoDynamix said that it intends to bring its technology 

platform to spine, general, OB, CV and thoracic surgery. 

101 

OrthoDynamix is a portfolio company of Gyrx 

(Jacksonville, Florida), a medical device business accelerator. 

It was established in 2007 to develop disposable steerable 

surgical instrumentation for arthroscopy. The company 

is a collaboration of the conveyed attributes of two medical 

device companies – Gyrx and Medicept (Ashland, 

Massachusetts). The combination will deliver multiple 

product offerings developed on one technology platform, 

Gyrx said. Initial products include steerable 5 mm grasper, 

punch and 3 mm RF hand instruments. 

According to the company, hip arthroscopy has not 

flourished due to the lack of effective instrumentation and 

corresponding surgeon training. OrthoDynamix said its 

ArthroSteer platform has been developed to compete in the 

$8 billion worldwide joint implant market. The arthroscopic 

device market is dominated by six large companies – 

Arthrex (Naples, Florida), Smith & Nephew (London), 

ConMed (Utica, New York), DePuy Mitek (Raynham, 

Massachusetts), Stryker (Kalamazoo, Michigan), and 

Arthrocare (Austin, Texas). 

(This story originally appeared in the July 30, 2009, 




102 

Bionic Proprio foot fitted on 

first U.S. amputee patients 



A bionic foot that replicates a natural human walking 

gait has, to date, been used primarily for members of the 

military. Further refined and now available to the general 

public, the Proprio Foot is likely to change the prosthetic 

landscape. 

“It’s the technology of the future,” said prosthetist Joe 

Reda, CPO, who is among the first technicians in the U.S. to 

be certified in the fitting of this device. “One of my first 

patients, a motorcycle rider, wore it on his bike to Sturgis 

Motorcycle Rally this week.” 

Reda is an assistant director at Kessler Institute for 

Rehabilitation (West Orange, New Jersey), one of the first 

rehabilitation centers in the country to offer the Proprio 

Foot developed by Ossur (Reykjavik, Iceland). 

“It’s the only computerized foot on the market,” Reda 

told Medical Device Daily. “The biggest limiting factor is the 

cost right now and reimbursement.” 

With a price tag of $34,000, it’s a bigger commitment 

than other foot prosthetics, which range in price from 

$5,000 to $18,000. 

The artificially intelligent prosthesis for transtibial 

amputees operates like natural, anatomical functioning. 

Developed by Ossur’s R&D department, the foot’s motion 

analysis capabilities are facilitated by real-time sensor 

technology from Dynastream Innovations (Cochrane, 

Alberta). 

The foot’s name is derived from its ability to detect 

where the foot is in space, known as proprioception. 

“It’s got tilt sensors,” Reda said. “It analyzes what the 

patient is doing and picks the toe up to allow the foot to 

clear the ground easier. Going up an incline, an amputee 

would generally walk on his toes and then down an incline 

on the heels because a regular prosthetic foot doesn’t have 

the flexibility. With the Proprio, after the second step it flexes 

the foot going up, so the patient does a natural heel-totoe 

gait. On the decline it does the same thing. When 

amputees go from sitting to standing, they usually use 

their good leg only, but with this foot, it flexes more so they 

can use both feet.” 

The Proprio includes sensor technology that mimics 

the body’s own neural receptors that are sensitive to 

mechanical change, providing artificial proprioception – 

the sense of where the limb is in space, according to Ossur. 

The artificial intelligence (AI) processes information from 

those sensors and activates the most appropriate response 

for the next step. The AI transmits an ongoing stream of 

signals that instruct precise actuator technology to act and 

deliver optimal function. 

It works unlike any other prosthetic limb Reda has ever 


used. But it lacks any cosmetic attributes. 

“It’s not a cosmetic leg by any stretch of the imagination. 

It’s fairly bulky,” said Reda, who is not affiliated with 

Ossur. “The ankle weighs 2 to 2.5 pounds with a large battery 

pack located on back of the socket. You can’t cover it. 

But the function of the foot outweighs the cosmetic aspect.” 

Designed for below-the-knee amputees, Proprio 

requires some basic programming when fitted with a 

patient that takes about 45 minutes. The battery stays 

charged for 36 hours before recharging is required. 

“The technology is there,” Reda said. “I’d like to see a 

smaller battery and unit.” 

He added that while the foot is not intended for athletic 

use such as running, it is designed for active people. 

Until now, the Department of Defense and the U.S. 

Department of Veterans Administration have actively used 

the foot to benefit service men and women returning from 

the Iraq and Afghanistan conflicts, as well as veterans of 

past wars, according to Ossur. 

The company is currently working to obtain Medicare 

reimbursement coding. 






Pacific’s bladder cancer test 

may trim invasive cystoscopies 



Bladder cancer, which afflicts more than 400,000 people 

globally each year, has a 98% survival rate if caught in 

the earliest stages. Initial testing and survivors must undergo 

repeated cystoscopies, an uncomfortable test, to diagnose 

and then check for disease recurrence, which is fairly 

common. 

Pacific Edge Biotechnology (Dunedin, New Zealand) 

has developed a rapid, urine test based on assaying RNA or 

proteins using multiple biomarkers with the potential to 

replace at least some of those cystoscopies. 

“It’s a very informative test and has great utility,” CEO 

David Darling told Medical Device Daily. “It’s designed to 

replace the cytology used as an adjunct to cystoscopy, 

which is the current gold standard. It’s a test used to triage 

a patient and then following on to determine if that patient 

has a superficial or invasive cancer.” 

Pacific Edge was recently issued a Singaporean patent 

for the test, which enables the early detection of bladder 

cancer from a relatively small volume of urine, just 50 milliliters. 

Darling said he anticipates patents from other countries 

to be issued over the next 12 to 24 months. 

“The idea is to minimize use of cystoscopes,” Darling 

said. “A patient often will receive a cystoscopy along with 

diagnosis. Then, European standard procedure is six follow-ups 

in the first year and then four per year thereafter. 

In the U.S., there are typically four follow-ups with cystoscopies 

and then two for the next four years. So that’s a 

total of 12 in the U.S. Those are all extremely invasive and 

rely on general anesthesia and it’s extremely expensive.” 

Darling said the test won’t entirely replace the need for 

cystoscopy. “It’s an important test, but urologists have 85% 

of cases that test negative and then need to follow up with 

a new more accurate test that’s not invasive and is more 

cost effective,” he said. “A lot of patients don’t want the 

invasiveness and general anesthetic. We expect to see 

some behavioral changes with this test. Urologists may 

reduce the number of follow-up tests.” 

While cystoscopy is the gold standard test, it presents 

challenges for patient compliance along with the fact that 

it’s relatively poor in efforts to actually assess tumors, 

Darling said. “Bladder cancer has the highest total medical 

costs of all cancers driven by two things: a strong requirement 

for monitoring following detection and the cost of 

overall detection technology,” he said. “There is a very high 

recurrence rate: 78% of early stage tumors recur and, of 

those, 30% come back as late stage tumor. It’s a very persistent 

disease.” 

Pacific Edge is currently conducting a 1,000-patient clinical 

trial – with sites in New Zealand and Russia – that is 

103 

expected to be completed within a few months. Darling 

said the FDA has indicated that an extra cohort is needed 

for approval in the U.S. 

“We’re currently talking to investigators in U.S. to put it 

together and then we will follow through with a PMA,” he 

said. “We’ve been talking to the FDA for a year and they are 

very happy with our trial design, but we need to add a 

cohort of American people. We’ve yet to design that but it 

will probably be 300 people.” 

Pacific Edge intends to first offer the test – to be named 

uRNA – to Australasian urologists through its Dunedinbased 

lab following completion of clinical trials later this 

year. Following that, commercialization will proceed in 

Singapore, Europe and the U.S. Darling said that Pacific Edge 

anticipates partnering in several of these locations for lab 

resources. The company is forecasting in excess of $100 

million in eventual revenues from the bladder cancer test. 

Bladder cancer isn’t the only target though for Pacific 

Edge, which is also developing colorectal and gastric cancer 

tests. The colorectal cancer prognostic test is nearing 

completion of commercial development and the company 

has licensed that technology to an as-yet-undisclosed 

German diagnostics firm. For gastric cancer, a prototype is 

currently undergoing validation rounds. 

Pacific Edge isn’t the only company developing a rapid 

bladder cancer test: 

Predictive Biosciences (Lexington, Massachusetts) is 

developing a test that makes use of a very traditional biomarker, 

but with a different way of looking at it: negative 

predictive value. It was designed this way because doctors 

want to be able to assure patients that they don’t have cancer 

(MDD, May 20, 2009). Earlier this year, Polymedco 

(Cortlandt Manor, New York) launched the BTA stat test for 

the early detection of recurrent bladder cancer. It employs 

monoclonal antibodies to detect the presence of bladder 

tumor associated antigen in urine (MDD, Feb. 9, 2009). 

(This story originally appeared in the June 1, 2009 edition 




104 

Private companies continue to 

draw value-minded investors 

By HOLLAND JOHNSON 

Medical Device Daily Managing Editor 

SAN FRANCISCO – As the Westin St. Francis Hotel began 

to empty out last Thursday as the annual J.P. Morgan 

Healthcare Conference was drawing to a close, there was 

enough interest in many of the private companies still to 

present to draw a crowd of investors looking for good 

value to add to their portfolios. 

Spiration (Redmond, Washington) is the maker of the 

IBV Valve, which is under investigation for use as a new 

treatment for patients with severe emphysema. 

President/CEO Richard Shea said the system is 

designed to redirect airflow from diseased portions of the 

lung to healthier areas. He said that during a minimally 

invasive procedure, the catheter is passed through a bronchoscope 

to deploy the small umbrella-shaped valves into 

the airways of the most diseased upper lobes of the lungs. 

Although the valves are intended to be permanent, they are 

designed to be removed via a minimally invasive procedure 

if necessary. 

Shea said the company already has done a 91-patient 

pilot study for use of the system in the U.S. as a new treatment 

option for patients with severe emphysema and is 

currently enrolling for a randomized, prospective, doubleblind, 

controlled pivotal trial. 

The company received a Humanitarian Device 

Exemption (HDE) for the system last October, specifically 

for patients who have lobectomy, segmentectomy or lung 

volume reduction surgery (Medical Device Daily, Oct. 28, 

2008). This HDE, said Shea “represents the first for a 

bronchial valve implant for the lungs designed specifically 

to address this complication.” 

In Europe, the system already has received CE-mark 

clearance for diseased and damaged lung, a broad indication 

that includes the treatment of emphysema and the resolution 

of air leaks. 

Spiration granted Olympus (Tokyo) and its distributors 

exclusive marketing and distribution rights for the IBV 

Valve System in 43 European countries, including the UK 

and other countries belonging to the European Union, representing 

what it said is the broadest distribution arrangement 

for a bronchoscopic treatment for emphysema in 

Europe. 

Shea called the market in the U.S. alone for this system 

a more than $1 billion opportunity. “There are clearly a 

bunch of other indications for the valve,” Shea said. “Over 

time, we would like to be able to help a broader group of 

patients.” 

Spiration is backed by an impressive group of 


investors, including Three Arch Partners, New Enterprise 

Associates, Versant Ventures, New Leaf Ventures (Sprout 

Group), InterWest Partners, Investor Growth Capital, Saints 

Capital and Olympus. 

Presenting Flowcardia’s (Sunnyvale, California) portfolio 

of catheter-based technologies to facilitate crossing 

of totally occluded coronary and peripheral arteries was 

company President/CEO Wick Goodspeed. 

According to Goodspeed, chronic total occlusions 

(CTOs) are considered one of the last major clinical challenges 

in interventional therapy. He noted that the absence 

of a safe and effective CTO recanilization system is a major 

reason that a large number of patients are still referred to 

coronary and peripheral bypass surgery and lower limb 

amputation. 

The company received an FDA 510(k) clearance for 

peripheral arterial disease (PAD) in December 2007 and for 

coronary arteries in January of that same year. The company’s 

Crosser catheter uses high-frequency mechanical vibration, 

which acts like a jackhammer to unblock the vessel and 

allow for subsequent angioplasty or other device follow-up. 

Goodspeed said that recently, there have been dramatic 

improvements in both morbidity and mortality when 

CTOs are opened. He also noted that there have been “technology 

improvements that will follow opening of a CTO.” 

On the peripheral side he noted the use of arthrectomy, 

stents, cryoplasty and laser devices. On the coronary side, 

drug-eluting stents are still the rage. “Even though these 

[CTOs] are hard to treat, it’s really worth it to open them 

because the benefit is there and if you can get them open, 

you can keep them open with drug-eluting stents and 

through other means.” 

Goodspeed estimated the worldwide market for CTOs 

as being around $800 million. 

Offering spinal product platforms in both degenerative 

and scoliosis sectors is Paradigm Spine (New York). 

Currently the company markets four products for the 

treatment of degenerative spine diseases. These include: 

the coflex Interlaminar/Intespinous stabilization device; 

the coflex-F posterior stabilization device; the DCI system 

designed as a functionally dynamic cervical spine implant; 

and the recently released DSS spinal stabilization system. 

The DSS system is a pedicle screw-based, implantable 

dynamic spine stabilization system indicated for degenerative 

disc disease (DDD) of the lumbar spine. The DSS system 

incorporates a hybrid philosophy, combining elements 

of fusion and motion preservation. 

Chris Hughes, the company’s president of U.S. operations, 

said Paradigm also is working on a predictive diagnosis 

opportunity for pediatric scolisosis. 

The trials are being conducted at Sainte-Justine 

University Hospital Center (Montreal). Paradigm entered an 

agreement with Sainte-Justine to provide cash and “various 




105 

other resources” through 2008 to complete trials of a blood 

test developed by Dr. Alain Moreau, director of Sainte- 

Justine’s Bone Molecular Genetics and Skeletal 

Malformations Laboratory. 

Paradigm will receive the exclusive worldwide license 

to commercialize, make, distribute or sub-license any 

device, genetic tests, therapeutic agents or “any future 

technology” developed based on Moreau’s research. 

The blood test is for determining melatonin-signaling 

dysfunction in children. And the level of that dysfunction 

that can be correlated with the scoliotic curve and the evolution 

of that dysfunction. 

In the U.S. the company has launched the DSS Pedicle 

Screws and Slotted Couplers in August 2008. The company 

received FDA approval in November for the Rigid Couplers 

and launched these couplers earlier this month. 

Hughes noted that his company’s gross margins “are 

averaging around 91% right now.” 





106 

PEAK gets FDA clearance, 

initiates PRECISE studies 



In the world of medical technology the most unique 

product ideas are often born in the university setting. Such 

was the case for PEAK Surgical (Palo Alto, California), 

which just received FDA clearance of expanded surgical 

indications for its PEAK Surgery System. 

The technology, designed to cut as precisely as a 

scalpel and control bleeding at a much lower temperature 

than traditional electrosurgical devices – therefore doing 

significantly less damage to surrounding tissues – was 

originally developed at the Hansen Experimental Physics 

Laboratory and department of ophthalmology at Stanford 

University (Stanford, California). The company was founded 

in 2006. 

The company yesterday reported receiving FDA 510(k) 

clearance to market its PEAK Surgery System for cutting 

and coagulation of soft tissue during plastic and reconstructive, 

ENT (ear, nose and throat), gynecologic, orthopedic, 

arthroscopic, spinal and neurological surgical procedures. 

The FDA cleared the system in July 2008 for general 

surgery. 

CEO John Tighe told Medical Device Daily that the FDA 

clearance the company received in July for general surgery 

was a “somewhat limited indication.” The expanded indications 

for the system – which includes the company’s 

PlasmaBlade family of disposable surgical cutting and 

coagulation devices – significantly broadens the company’s 

ability to market for specific indications. 

With the expanded indications, Tighe said PEAK is targeting 

more than 2 million procedures in the U.S. alone. 

“With the FDA clearance of expanded surgical indications 

and the initiation of our comprehensive clinical study 

program, PEAK Surgical is poised to drive adoption of the 

PlasmaBlade based on clinical outcomes,” Tighe said. “We 

have already seen significant adoption of the PlasmaBlade 

by U.S. surgeons, as they discover how easy it is to use and 

how precisely it cuts tissue and controls bleeding without 

causing extensive collateral thermal damage to tissues.” 

He added, “We expect the results of our PRECISE studies 

to further validate our preclinical results showing effective 

bleeding control, minimal thermal tissue injury, positive 

wound healing, minimal scarring and inflammation, and 

improved surgical incision healing and strength compared 

with traditional electrosurgical devices.” 

The system includes the PEAK PlasmaBlade family of 

disposable surgical cutting and coagulation devices. The 

PlasmaBlade tissue dissection devices are used in conjunction 

with PEAK’s Pulsar Generator, which is designed to provide 

pulsed plasma radiofrequency energy to the 


PlasmaBlade to incise tissue and control bleeding. The 

PlasmaBlade offers the exacting control of a scalpel and the 

coagulation of traditional electrosurgery without causing 

extensive collateral damage, according to PEAK. Since FDA 

clearance, surgeons in the U.S. have used the PlasmaBlade 

in nearly 350 surgical procedures, including in general, 

gynecologic, cardiothoracic and plastic and reconstructive 

surgeries, the company noted. 

“Because the PlasmaBlade cuts at a lower temperature 

than traditional electrosurgical devices, it reduces collateral 

tissue damage and scarring, which is important for 

patients undergoing plastic surgery procedures,” said 

Howard Rosenberg, MD, former chief of surgery at El 

Camino Hospital (Mountain View, California), and co-primary 

investigator of an ongoing clinical study evaluating 

the PlasmaBlade in abdominoplasty (tummy tucks). “We 

expect that the clinical study under way at our hospital will 

demonstrate improved healing, reduced pain and less postoperative 

drain output (serous fluid) with the PlasmaBlade 

compared with electrosurgery.” 

“We have been impressed with the reduced tissue charring 

and the ability to work close to delicate and sensitive 

tissues with the PlasmaBlade, which is especially important 

in gynecologic procedures in which the bowel, ureter and 

ovaries are close by,” said Fermin Barrueto, MD, chief of 

endoscopy and pelvic reconstruction at Mercy Medical 

Center (Baltimore) and primary investigator of an ongoing 

clinical study evaluating the PlasmaBlade in hysterectomies. 

“We expect that the clinical study we are conducting 

will show less collateral thermal injury to uterine tissue and 

less post operative pain, due to the lower temperature 

associated with the PlasmaBlade compared with traditional 

electrosurgery,” he said. 

The company also said it has initiated a series of clinical 

studies, called the PRECISE studies (Pulsed Plasma 

Radiofrequency Energy to ReduCe Thermal Injury and 

Improve Surgical HEaling), to evaluate the use of the system 

in plastic, gynecologic and oncologic surgery. It recently 

initiated two clinical studies in plastic and gynecologic 

surgery, with three additional studies in plastic, gynecologic 

and oncologic surgery planned. All will evaluate the operative 

performance and clinical results of the PlasmaBlade 

compared with traditional electrosurgery. Results from the 

five PRECISE studies are expected in the first half of 2009. 

For decades, surgeons have relied on scalpels to cut 

skin and delicate tissues and have used electrosurgical 

devices to cut and coagulate fat and other thicker, tougher 

tissues. Although scalpels precisely cut tissue, they do not 

control bleeding. 

Electrosurgical devices, on the other hand, cut efficiently 

and control bleeding but cause extensive thermal 

damage to surrounding tissue, PEAK noted. In cases where 

the risk of collateral damage or scarring from electrosurgery 

is considered to be unacceptable, surgeons must 




107 

use both a traditional scalpel for cutting and an electrosurgical 

device for coagulation. PEAK said its PlasmaBlade 

offers the best of both worlds – the precision of a scalpel 

and the bleeding control of a traditional electrosurgery 

device in a single surgical device. 

Unlike most radio frequency-based surgical products 

that use continuous voltage waveforms to cut tissue, the 

Pulsar Generator supplies pulsed plasma-mediated electrical 

discharges through the PlasmaBlade. Because the 

radiofrequency energy is provided through short on-andoff 

pulses via a highly insulated cutting electrode, the 

PlasmaBlade cuts at an average temperature that is half 

that of a conventional electrosurgery device and can be 

as low as 50 degrees Centigrade. PEAK said the 

PlasmaBlade also is able to dissect tissue in a wet or dry 

surgical field. 





108 

PLC Systems to unveil results 

from MYTHOS clinical trial 

By OMAR FORD 


PLC Medical Systems (Franklin, Massachusetts) 

reported that the initial abstract results from a clinical 

study evaluating the effectiveness of its RenalGuard 

System have been published. The company said that the 

investigator-sponsored clinical study has also been published 

on the European Society of Cardiology (Sophia 

Antipolis, France) web site in advance of that society’s 

annual meeting Aug. 29 – Sept. 2, 2009 in Barcelona, Spain. 

The CCM trial, known as MYTHOS, is a randomized clinical 

trial designed to provide an assessment of the potential 

benefits of induced diuresis with automated matched 

hydration therapy utilizing RenalGuard, compared to standard 

overnight hydration, a prevalent method of treatment 

in the EU, in the reducing the incidence of contrast-induced 

nephropathy (CIN) in patients undergoing cardiac catheterization 

procedures and percutaneous coronary interventions 

with baseline impairment in renal function. The study 

is designed as a non-inferiority trial, with the primary endpoint 

defined as equivalency or better to overnight hydration. 

“What the investigators are attempting to show is that 

the RenalGuard is just as good if not better than any of the 

rehydration therapies available out there,” president/CEO 

Mark Tauscher told Medical Device Daily. “RenalGuard 

works in the same amount of time as a cardiac catheterization 

and is used continually up until a patient checks into 

the cath lab.” 

The system is designed to reduce the toxic effects that 

contrast media can have on the kidneys when it is administered 

to patients during certain medical imaging procedures. 

It does this by inducing and maintaining a high urine 

flow rate before, during and after these medical imaging 

procedures. It is believed that allowing contrast media to 

dwell in the kidneys can lead to CIN, a potentially deadly 

form of acute kidney injury. 

RenalGuard includes a console and a RenalGuard Single 

Use Set for infusion and urine collection. The Single Use Set 

contains a urine collection set which connects to a patient’s 

Foley catheter and an infusion set which connects to a standard 

IV catheter. The console measures the volume of urine 

in the collection set and infuses an equal volume of hydration 

fluid to match the patient’s urine output. 

The console relies on proprietary software and electronic 

weight measurements to control the rate at which 

fluid is infused and to monitor urine volume. 

The console is mounted on a standard IV pole and is 

equipped with an internal battery that allows operation 

while the patient is being transported within a hospital. 

Tauscher added that it eliminates the need for patients 


to come in over night and be hydrated – a procedure that’s 

costly in time and money to the patient and care providers. 

The preliminary results provided by the company on 

the clinical study delve into details on 43 patients at high 

risk for renal failure. The final study is expected to include 

nearly 120 patients. The initial results indicate that none of 

the patients treated with RenalGuard while undergoing 

imaging procedures acquired CIN, but 17% of those who 

were treated beforehand with overnight hydration did 

acquire CIN. 

The results go on to show that two of the patients in 

that group required temporary renal replacement therapy. 

Acquiring CIN has been found to lead to a range of serious 

and potentially deadly outcomes in patients who already 

have compromised kidney function. 

PLC first received the CE mark for the RenalGuard 

System in December 2007, and concluded its pilot safety 

trial in the U.S. late in 2007. In March 2008, PLC signed its 

first international distribution agreement for RenalGuard 

with Artech (Cavezzo, Italy) for distribution of its 

RenalGuard System into Italy. Nearly a year later the company 

reported gaining a second European distributor, Izasa 

Distribuciones Tecnicas (Barcelona, Spain), for the distribution 

of RenalGuard in Spain. 

The company has received full approval from the FDA 

to commence a U.S. pivotal trial to study the effectiveness 

of RenalGuard in reducing the incidence of CIN. 

The company previously put plans on hold for the 

device after the market dropped in 2007. 

“When the stock market collapsed we didn’t think we 

could raise any more money,” Tauscher said. “We’re hoping 

this data will be instrumental in helping us raising funds in 

the U.S. and that investors will see that this device has 

strong data and that they can invest in it. We’re also hoping 

this data will drive more sales in Europe.” 






Non-magnetic motor to power 

new prostate cancer device 



With the side effects of current prostate cancer treatments 

sometimes worse than the disease itself – incontinence 

and impotence, to name just a couple – several companies 

are trying to find a cure that either eliminates or significantly 

reduces these problems. 

Profound Medical (PMI; Toronto), a spin-off of 

Sunnybrook Health Sciences Centre (also Toronto) founded 

last fall, knew when it decided to develop a device to treat 

prostate cancer that it would require the kind of visibility 

only found with MRI. That presented the challenge of 

designing a device that is completely MRI-compatible, 

including the motor. 

As a solution to that problem, the company partnered 

with Johnson Medtech (Shelton, Connecticut), the medical 

products division of Johnson Electric, which makes nonmagnetic 

Nanomotion actuators that are being used to 

power PMI’s MRI-compatible image-guided tumor treatment 

device. 

According to PMI, the device is expected to treat 

prostate cancer in a fraction of the time and cost of existing 

methods, based on extensive modeling, simulation and 

pre-clinical trials. 

Johnson Medtech said its Nanomotion actuators enable 

the precision of motion and accuracy of treatment necessary 

for safely conducting the image-guided prostate cancer 

therapy within the strong magnetic field of the MRI. 

CTO Michael Bronskill, PhD, and Rajiv Chopra, PhD, 

chief science officer, initially developed PMI’s device at the 

Sunnybrook center. The company said it is working toward 

FDA approval for the device. 

“When designing our prostate cancer treatment device, 

we knew that it would require the visibility exclusively 

available in an MRI environment. However, conventional 

motors were a roadblock to creating a working proof-ofconcept 

device and bringing this important development 

to reality – and only Johnson Medtech could provide the 

solution,” Bronskill said. “Johnson Medtech’s Nanomotion 

non-magnetic motors provide the motion necessary to 

enable our tissue coagulation device to effectively treat 

prostate cancer patients within the MRI environment, and 

with a degree of precision that is crucial to success.” 

Alan Feinstein, president of the Nanomotion division at 

Johnson Medtech, told Medical Device Daily that the company 

has been working with Sunnybrook, and now PMI, for 

about four or five years to develop this prostate cancer 

device. He said it is one of “numerous” devices that Johnson 

Medtech has helped with because the device is required to 

function in the magnetic field of MRI path and the motor 

and the entire mechanism needs to be nonmagnetic. 

109 

PMI’s device uses an MRI for imaging and a planar ultrasound 

applicator for treatment. The MRI guides the probe 

that heats the cancerous tissue to destroy the diseased 

area, according to the company. 

In the past, the magnetic nature of electric motors and 

their metal components made it impossible for motorized 

medical devices to function within the MRI environment. To 

overcome this challenge, PMI selected Nanomotion’s HR2-1- 

N-3 piezo ultrasonic non-magnetic motors to rotate the 

device’s probe. When combined with the real-time noninvasive 

visibility into the human body provided by the 

MRI, the sophisticated low-speed Nanomotion actuators in 

PMI’s device enable medical professionals to operate the 

probe at a microscopic scale to conduct this procedure, the 

companies said. 

Feinstein said the motor has a non-magnetic metal 

body as well as some ceramic material and some plastics. 

According to PMI, prostate cancer afflicts millions of 

men around the world, with an estimated 400,000 new 

cases diagnosed each year. Several prostate cancer treatments 

are available, including radiation, the company 

noted. But even the treatments with high success levels 

leave the patient with enduring and sometimes permanent 

impotency and incontinence problems in the vast majority 

of cases. 

PMI says its minimally-invasive thermal ablation device 

powered by Nanomotion’s motors treats prostate cancer as 

well as or better than radiation, and projects to deliver significantly 

fewer side effects based on pre-clinical research. 

While some radiation methods often require up to 12 weekly 

one-hour treatments, PMI’s device completes the treatment 

process in just one visit, and with far greater accuracy 

for targeting the affected area, the company said. 

“Scientists have worked for years to develop a prostate 

cancer treatment that yields no inconvenient side effects to 

the patient, but the extreme degree of precision required to 

target and treat a small area has been limited by human 

ability and legacy devices,” said Jim Dick, senior VP of 

Johnson Electric and chairman of Nanomotion. “Working 

together with Profound Medical, Johnson Medtech is proud 

to be part of the design team that solved the challenges of 

delivering a device to treat prostate cancer victims more 

quickly and safely.” 

Just last year a U.S. task force recommended that men 

75 or older should not even be screened for prostate cancer 

because of evidence of more harm than benefit from 

carrying out this procedure and providing therapy based 

on a positive diagnosis. These harms are especially important, 

the task force noted, because some men who are treated 

for prostate cancer would never have developed symptoms 

in their lifetime. 

PMI says its technology combines the therapeutic benefits 

of thermal ultrasound with the “unparalleled accuracy, 

sensitivity, and precision of MRI to allow the most precise 

treatment of a region or the whole prostate.” This accuracy 



110 


of treatment is critically important, the company says, if the 

nerve bundles for potency, and the continence of the urethra 

and rectum are to be spared. 

Current management strategies for localized prostate 

cancer include watchful waiting, radiation therapy, active 

surveillance (periodic biochemical monitoring with conversion 

to curative treatment if disease progresses), radical 

prostatectomy, and brachytherapy (or radioactive seed 

implantation therapy). 

Other companies also are working to provide a treatment 

for prostate cancer without the side effects of conventional 

radiation therapy. 

Recognizing that movement of the prostate during 

treatment is one of the major limiting factors of prostate 

cancer treatment, Accuray (Sunnyvale, California) introduced 

a device last year, the InTempo adaptive imaging 

system, to help radiologists overcome the challenge. The 

imaging device is designed to enhance the CyberKnife 

robotic radiosurgery system’s ability to track and correct 

for motion of the prostate during treatment. The system is 

like an artificial intelligence that calculates where the 

prostate is. The more the device sees the organ moving, the 

faster the pictures are taken, automatically correcting the 

robot. 






Prostate mechanical imaging 

may improve cancer detection 



The diagnosis and treatment of prostate cancer is rife 

with controversy. Because it’s such a slow-growing cancer 

and therapy carries significant risks, a case can be made to 

skip treatments altogether. But for men whose prostate 

cancers happen to be fast growing – or near the prostate 

wall – it’s imperative to get an early, accurate diagnosis. 

Akin to the function of mammography, the ProUroScan 

is a new medical imaging technology that creates a map or 

a digital record of the prostate to identify abnormalities 

detected by digital rectal exam (DRE). “When we survey the 

prostate with our probe, we create a map, a 3-D picture of 

what a prostate would look like,” 

Rick Carlson, CEO of ProUroCare Medical 

(Minneapolis), told Medical Device Daily. “Once we create 

the map for any patient with any condition of any type, it 

creates a baseline, which says we have a patient with a suspicious 

condition and now we know where it exists.” That 

map, created by this new method called prostate mechanical 

imaging (PMI), can be saved as a permanent electronic 

record and compared to other maps created in successive 

evaluations. 

The American Cancer Society (Atlanta) estimates that 

there are more than two million men in the U.S. diagnosed 

with prostate cancer. One out of 35 men will die from this 

type of cancer, but it’s difficult to identify those with 

aggressive disease. The two primary screening tests for 

prostate cancer, the DRE and the prostate specific antigen 

(PSA) blood test, are not 100% accurate. An abnormal result 

isn’t a confirmation of cancer and a normal result doesn’t 

mean cancer isn’t present. Biopsies are another option, but 

unless the needle hits cancerous tissue, it can be missed. 

Given these concerns and complications, ProUroCare 

has taken a different approach to the diagnostic process. 

“Any soft tissue organ, by definition, does not generally 

have abnormal tissue formations unless there is something 

going on,” Carlson said. “The map created by ProUroScan is 

akin to a weather map. We’re measuring the displacement 

of tissue. The more tissue you displace the lighter the color. 

“Any dark formations are an indication that elasticity is 

different. Over time, we’ll be able to say that tissue is not 

only different, but in fact is most likely a cancer formation. 

As we see changes in the sizes in the elasticity being different 

it tells us if it’s expanding or moving closer to the 

wall of the prostate. All are indications for physician that 

you may have a more progressive disease or a more benign 

disease.” 

Carlson explained that PMI is not ultrasound or thermal 

mapping, but a mechanical mapping done with the aid of a 

probe equipped with pressure sensor arrays. 

111 

“We would see this test being done repeatedly over 

time so that a physician would be able to compare changes 

that occur,” he said. 

To date, nine peer-reviewed articles have been published, 

the latest of which was in Urology last year. That 

study, led by ProUroScan co-inventor Armen Sarvazyan, 

PhD, founder and CSO of Artann Laboratories (Trenton, 

New Jersey), presented data from 168 patients. In 84% of 

cases, PMI provided “data sufficient for quantitative assessment 

and image reconstruction of the prostate,” the study 

authors wrote. “Four potential causes of the 16% failure 

became apparent: anatomical limitations such as position 

of the prostate relative to sphincter and/or bladder (5%), 

insufficient pressure applied (5%), excessive noise from 

sensors (4%), and inability of the examiner to locate the 

prostate upon insertion of the probe (2%).” 

PMI successfully imaged 10 of 13 malignant nodules and 

was consistent with all eight reported biopsy-negative 

cases. For the same group, the DRE identified six of 13 cancer-positive 

cases and produced one false-positive result in 

the eight non-cancerous cases. Overall, the study authors 

agreed that PMI “may significantly add to the technology 

diagnostic potential.” ProUroCare has since launched a new 

40-patient study as required by the FDA for 510(k) approval 

that’s expected to be completed in August. 

If approved and launched, Carlson said the system, 

basically a small computer with a probe attached, would 

cost under $10,000 and would be used in a physician’s 

office if either a DRE or PSA test were suspicious. “Our goals 

is to make this a non-capital system purchase,” he said, 

comparing it to the average $150,000 cost of an ultrasound 

machine. “We would see physicians having it in their offices 

and keeping their own images to compare over time. 

Initially, the test (estimated to be $200) would have to 

be paid for by patients out of pocket but the company 

intends to pursue CPT coding. Last year, ProUroCare 

entered into two agreements with Artann to complete 

development, conduct clinical trials and file for FDA clearance 

for ProUroScan (MDD, August 1, 2008). If ProUroScan is 

approved for marketing, Carlson said the company will 

seek out a relationship with a larger medical device firm for 

marketing and distribution rather than building its own 

sales force. 





112 

ReGen meniscus repair implant 

wins 510(k) path market okay 


After two previous failed attempts to win FDA PMA 

approval for its Menaflex collagen meniscus implant, 

ReGen Biologics (Hackensack, New Jersey) has finally 

received 510(k) clearance to market the product, a scaffold 

designed to reinforce and repair soft tissue knee injuries of 

the medial meniscus. 

The company switched from a PMA (premarket application) 

– considered the FDA’s most stringent type of marketing 

review, usually for devices that are used more invasively 

and with significant risk – to the less arduous 510(k) 

regulatory pathway. 

An FDA advisory committee met in November 2008 to 

review ReGen’s 510(k) application, usually reserved for 

products for which PMA approvals are sought. And in doing 

so the agency appeared to be signaling its intent to more 

closely regulate all medical devices, not just those that 

come under PMA review. 

Summarizing the views of the members at the advisory 

meeting, its chair, Jay Mabrey, MD, of Baylor North Texas 

Orthopaedic Specialists (Dallas), said, “the panel generally 

believes that the device is safe, but its effectiveness 

remains to be seen.” He said “the sense of the panel is that 

yes, it is as safe and effective.” The panel also generally 

agreed that the device was appropriate for use in both 

chronic and acute injuries. 

The panel’s conclusions were then taken by the Center 

for Devices and Radiological Health as support for okay of 

the clearance. In January 2006, the company decided to opt 

out of the PMA route. 

At the time, CEO Gerald Bisbee, Jr., PhD, said the rationale 

for taking the 510(k) route is based on the fact that predicate 

devices, including surgical patches recently had been 

cleared, including two in 2005. 

The Menaflex is designed to guide new tissue growth, 

following removal of damaged meniscus tissue, using the 

body’s own healing process. It provides a resorbable scaffold 

for the growth of new tissue in the meniscus. 

“We are extremely pleased that the FDA has considered 

the recommendations of the Orthopaedic and 

Rehabilitation Devices Advisory Panel in support of our collagen 

scaffold 510(k) and that the FDA agreed to enable U.S. 

marketing for this important product,” said Gerald Bisbee, 

Jr, PhD, CEO and chairman of ReGen. The announcement of 

FDA clearance, he said, “represents the culmination of many 

years of effort on the part of the company and the invaluable 

contribution of many supportive investors, advisors 

and surgeons, as we sought to bring the Menaflex product 

to the U.S. market.” 

The potential market for ReGen’s Menaflex includes a 

large portion of the estimated annual 1.3 million partial 


meniscectomies worldwide. Partial meniscectomies 

increase for those patients who have had previous procedures. 

And, about 65% of partial meniscectomies occur on 

the medial meniscus. 

ReGen said that it will seek expansion of the indication 

for use in the lateral meniscus through a new 510(k) application 

to be submitted to the FDA, with support by data 

from its ongoing European post-market study. 

Menaflex is marketed in Europe for both medial and lateral 

indications. 

Data backing up ReGen’s claims of efficacy include a 

recent study of 311 patients with an irreparable injury of the 

medial meniscus or a previous partial medial meniscectomy, 

treated by a total of 26 surgeon-investigators at 16 

sites. 

Patients in the study, titled “Comparison of the 

Collagen Meniscus Implant with Partial Meniscectomy” 

received either the collagen meniscus implant, or served as 

a control subject treated with a partial meniscectomy only. 

Patients who had a collagen meniscus implant were 

required to have second-look arthroscopy at one year to 

determine the amount of new tissue growth and to perform 

a biopsy to assess tissue quality. 

The study authors concluded that new biomechanically 

competent meniscus-like tissue forms after placement of 

a collagen meniscus implant, and use of the implant 

appears safe. 

The implant supports new tissue ingrowth that 

appears to be adequate to enhance meniscal function as 

evidenced by improved clinical outcomes in patients with a 

chronic meniscal injury. 

However, “The implant was not found to have any benefit 

for patients with an acute injury,” the study’s authors 

wrote in a report published in The Journal of Bone and Joint 

Surgery. 






113 

Sanomedics launches 

healthcare subsidiary 


Sanomedics International Holdings (SIH; Miami), 

reported the launch of Sanomedics Development Corp., 

to be led by Abhishek Shrivastava, CTO. 

A wholly owned subsidiary of SIH, Sanomedics 

Development will be an incubator for identifying and swiftly 

bringing to market healthcare-focused solutions in information 

technology, software, medical devices, services and 

tele-health applications. These new solutions for the 

healthcare industry are anticipated to reduce cost, increase 

quality and improve healthcare efficiency overall. 

“With healthcare consuming over a trillion dollars 

annually as a greater proportion of the Gross National 

Product, this indusy is positioned for an explosion in the 

development of new technologies to reduce cost and 

improve quality,” said Keith Houlihan, president/CEO of SIH. 

“Efforts at healthcare reform undertaken by President 

Obama focus on improved uses of information technology 

with the development of new devices and services to meet 

the two major goals of reform - improved quality and 

reduced cost. Sanomedics Development is our effort to 

find, fund and bring to market as rapidly as possible these 

newly emerging solutions through Sanomedics 

International.” 

Sanomedics Development Corporation will be funded 

and controlled by SIH. “This will allow for rapid product 

evaluation and decision-making in regards to newly discovered 

opportunities,” said Shrivastava. “In my view, the 

uncontrolled ever escalating costs across the healthcare 

industry are unsustainable. New innovations combined 

with speed to market and rapid adoption is critical in providing 

effective and affordable solutions to the problems 

facing healthcare today.” 

Sanomedics manufactures and distributes medical and 

home health products. 





114 

New computer system to aid in 

artificial pancreas development 



Scientists are getting closer to developing an artificial 

pancreas for patients with diabetes and a new computersimulated 

system created by California researchers should 

bring the artificial pancreas even closer to the market. 

The system, created by researchers at the University of 

California at Santa Barbara, Sansum Diabetes Research 

Institute (Santa Barbara) and Stanford Medical Center 

(Palo Alto), is designed to help scientists evaluate an investigational 

artificial pancreas comprised of an insulin pump 

and a continuous glucose monitor. Research about the system 

was published in this month’s issue of Diabetes 

Technology & Therapeutics. 

Specifically, the investigational artificial pancreas is 

comprised of the OmniPod Insulin Management System 

from Insulet (Bedford, Massachusetts) – including the 

OmniPod insulin pump and Personal Diabetes Manager that 

controls it –and a continuous glucose monitor, in this case 

either the FreeStyle Navigator from Abbott Diabetes Care 

(Alameda, California) or the DexCom STS7 from DexCom 

(San Diego). The new system includes an algorithm that 

automates the interaction between the pump and monitor, 

and facilitates the running of a variety of tests and challenges 

to the software and component devices. The UC 

Santa Barbara-developed software and algorithms are also 

being used with a number of other pumps and monitors in 

developing additional systems, according to the 

researchers. 

Howard Zisser, MD, director of clinical research and diabetes 

technology at the Sansum Diabetes Research 

Institute, told Medical Device Daily that the new system 

provides a testing platform where researchers can test all 

of the components together, as opposed to testing each 

component individually. Hopefully, he said, that will help 

with the regulatory process of the artificial pancreas. 

“I think it’s nice for [FDA] to see everything operating as 

one . . . it really helps to have everything in one system that 

we can test the whole system,” Zisser said. “You don’t want 

to have a system that the components work but when you 

plug them all together they don’t work and that is one of 

the concerns of the FDA . . . what happens when they start 

communicating together” 

The research is part of the artificial pancreas project, 

which is funded by the Juvenile Diabetes Research 


Foundation (New York) and is being conducted by an international 

group of diabetes research centers. The project’s 

first goal is to integrate an insulin pump and continuous 

blood glucose monitor to closely replicate a healthy pancreas 

for patients with Type I diabetes – patients whose 

pancreases no longer produce insulin, which is used by the 

body to control blood glucose levels. An artificial pancreas 

will allow for tighter and automated control of blood glucose 

levels, which would significantly help to avoid the 

long-term complications of the disease. 

“While we still have a ways to go, this new system 

brings us much closer to making the artificial pancreas a 

reality for Type I diabetes patients,” said lead author Eyal 

Dassau, PhD, diabetes team research manager at UC Santa 

Barbara. “This achievement is vital – we now have a way, 

prior to patient trials, to fully verify and validate that an 

artificial pancreas can efficiently operate in the variety of 

conditions reflective of a large group of patients with this 

disease.” 

Zisser said the new system would help streamline the 

preclinical trials. “We plan to begin using it in the next several 

months,” he added. 

The other advantage of using the new system is that it 

is “plug and play,” Zisser said. “We’re going to be adding 

more pumps, more sensors, as they come on line.” 






Sanuwave’s dermaPACE promotes 

internal healing in patients 

By OMAR FORD 


Usually wound therapies are treatments that include 

some sort of external component to help a patient heal. 

Sanuwave (Alpharetta, Georgia), a developer of noninvasive, 

biologic response activating devices in the regenerative 

medicine segment, is looking at going against conventional 

woundcare therapy logic and has developed an 

application that will stimulate the bodies own natural ability 

to heal. 

With dermaPACE, (Pulsed Acoustic Celluar Expression), 

the company is seeking to obtain an investigational device 

exemption from the FDA in looking at the safety and efficacy 

of the device in healing diabetic foot ulcers. The company 

reported adding its 22nd site to a clinical trial for 

dermaPACE last week. 

“Instead of trying to deal with healing externally, we’re 

actually trying to stimulate the body’s own healing ability,” 

Christopher Cashman, president/CEO Sanuwave, told 

Medical Device Daily. 

The device delivers pulsed acoustic energy waves to 

the affected area of the patient Cashman said, adding this 

energy is what stimulates the healing process. 

The enrollment for the dermaPACE trial for healing diabetic 

foot ulcers recently reached 75% completion. With 19 

other trial sites in the U.S. and two international sites in the 

UK and Germany, the Southern Arizona VA site becomes the 

twenty-second site that is actively recruiting subjects for 

the dermaPACE trial. 

The objective of this clinical study is to compare the 

safety and effectiveness of the dermaPACE device to sham 

application, when administered in conjunction with the 

standard of care, in the treatment of diabetic foot ulcers. It 

is a randomized, double blind, placebo control, parallel 

assignment study design. The company said that 200 

patients would be involved in the clinical study. 

“So what would happen would be, a patient would 

come in, the physician would clean the affected site, apply 

gel and fire about five hundred pulses to the affected area,” 

he said. 

Patients in the active study arm receive four treatments 

over a two week period of pulsed acoustic energy waves to 

their wound. 

“Each patient is different but we believe the body will 

respond adequately after the four treatments,” Cashman 

said. 

The trial is set to end sometime next year, with the 

company hoping to launch the device in the U.S. in 2011. The 

device was already cleared in Europe. 

The company believes the device will have a tremendous 

impact in the diabetic illness market. According to 

115 

the American Diabetes Association (Alexandria, 

Virginia), 23.6 million people in the U.S. suffer from diabetes 

and another 57 million are pre-diabetic. 

The National Institutes of Health (NIH) reported that 15% 

of people with diabetes will acquire a non-healing ulcer in 

their lifetime, and chronic leg wounds (ulcers) are estimated 

to account for the loss of two million workdays a year at 

a cost of nearly $300 million in lost productivity. Diabetic 

foot ulcers are a recurrent condition and lead to more than 

82,000 amputations annually. The Advanced Medical 

Technology Association (Washington) estimates it costs 

roughly $60,000 for a lower limb amputation that can 

result from a diabetic foot ulcer, representing an annual 

cost of $5 billion. Hospitalization costs alone for a patient 

with a diabetic foot ulcer can reach $16,000-$20,000 annually. 

“We are very encouraged by the support that the 

wound care medical community has shown our dermaPACE 

trial and their continued desire to join as the study nears its 

final enrollment stage,” Cashman said. As our clinical trial 

continues, we believe that we are getting closer to being 

able to offer the healthcare community and the patients 

who suffer from an estimated 1.5 million diabetic foot ulcers 

in the U.S. alone, a unique solution to a demanding medical 

problem at a reasonable cost.” 

Sanuwave was founded in 2005 and has a portfolio of 

products for the biologic signaling and angiogenic 

responses to restore the bodies natural healing process. 

The company already has a U.S. Class III PMA approval for 

its OssaTron device which stimulates healing in the foot 

and the elbow. 

(This story originally appeared in the Aug. 25, 2009 




116 

Retinal prosthesis eyes potential 

to restore limited sight to blind 



Retinitis pigmentosa and age-related macular degeneration 

are two of the leading causes of blindness for which 

there is no curative treatment. But scientists at the 

Massachusetts Institute of Technology (MIT; Boston) are 

developing a retinal prosthesis that would take over the 

function of lost retinal cells by electrically stimulating the 

nerve cells that normally carry visual input from the retina 

to the brain. 

A small company, Second Sight Medical Products 

(Sylmar, California), earlier this year was granted FDA 

approval for a 20-patient clinical trial of a similar implant in 

development, but the MIT team is betting their version has 

a key advantage that will move its prosthesis to the head of 

the pack in the race to commercialization. 

“Second Sight has a huge amount of capital and team 

three times the size of ours, but we think our approach is a 

much better idea,” John Wyatt, MIT professor of electrical 

engineering and project leader, told Medical Device Daily. 

“We used to put them inside and fix them to the retina. The 

tissue beneath the retina is the most vascular in the body. 

We decided to come in through a little incision in the white 

and come through to the retina from the back.” 

The implant under development, inspired by the functionality 

of cochlear implants, would not restore normal 

vision, but could help blind people to more easily navigate 

their environments. 

The MIT group, as well as Second Sight, initially developed 

implants that were implanted inside the ocular cavity, 

called epiretinal implants. 

“Our group initially focused on an epiretinal approach, 

but after nearly a decade of sobering experience we decided 

it best to pursue a subretinal approach instead,” Wyatt 

said, adding that epiretinal approach introduces a greater 

danger of bleeding in the eye when mounting an array or 

an entire electronic system epiretinally using either adhesives 

or retinal tacks. There’s also a postsurgical risk of 

eventual detachment and bleeding, among other potential 

complications. 

“As we discovered these impediments, we eventually 

decided to switch to a subretinal approach to the implant 

design,” Wyatt said. 

A new design emerged – one in which the bulk of the 

implant is attached to the outside of the sclera except for a 

thin microelectrode array penetrating the sclera to stimulate 

the retina electrically from a subretinal location. 

“A little bit of bleeding into the eye is extremely 

destructive,” Wyatt said. “We though it was safer our way.” 

Once the implant is in place, the patient would wear 

glasses mounted with a tiny camera that sends images to a 


microchip attached to the eye. The glasses also contain a 

coil that wirelessly transmits power to receiving coils surrounding 

the eyeball. When the microchip receives visual 

information, it activates electrodes that stimulate nerve 

cells in the areas of the retina corresponding to the features 

of the visual scene. The electrodes directly activate optical 

nerves that carry signals to the brain, bypassing the damaged 

layers of retina. 

Aside from testing the system in animals, the MIT 

group implanted six patients with a prototype for a single 

day to do experiments, which confirmed that retinal stimulation 

can produce some kind of organized vision in blind 

patients. But they won’t know exactly how well the implant 

works until they test it fully in humans with chronic blindness, 

“because cortical learning [like what happens with 

cochlear implants] happens over weeks to months, not 

hours,” Wyatt said. 

With backing from the VA Center for Innovative Visual 

Rehabilitation, the National Institutes of Health, the 

National Science Foundation, the Catalyst Foundation 

(Lancaster, California) and the MOSIS (Marina del Rey, 

California) microchip fabrication service, the group intends 

to start testing in blind patients within the next two years 

pending FDA approval. In the midst of this, Wyatt said, they 

are working to either spin out a company or outlicense the 

technology. 

A special surgical technique has been developed to 

facilitate subretinal implants and the MIT group has reported 

a success rate of about 90% in pigs. Additionally, they 

have switched from using a silicone exterior to hermetically 

sealed titanium, which can stand up to saline exposure 

for decades unlike silicone. 

In May, Second Sight reported that FDA granted 

approval for up to 20 people who are blind or who have 

severely impaired vision due to the genetic eye disease, 

retinitis pigmentosa, to participate in the Argus II Retinal 

Implant feasibility study in the U.S. 






Close accounting of the best 

kind aids intraocular pressure 

117 

By K. JOHN MORROW Jr. 

Medical Device Daily Contributing Writer 

Glaucoma, a leading cause of blindness, is estimated by 

the World Health Organization (Geneva, Switzerland) to 

affect 70 million people worldwide. Although increased 

intraocular pressure has long been recognized as its leading 

cause, this pressure has proven elusive to measure 

accurately. Indeed, it can vary widely over the course of the 

day, and may escape detection. 

There is growing consensus among students of the 

phenomenon that intraocular pressure rises at night, where 

it could wreak maximum havoc. A body of evidence from 

circadian studies on animal models supports this belief; 

pressures measured in the light phase were significantly 

lower than those in the dark phase. However, the situation 

in humans is complex, and both higher and lower nocturnal 

pressures have been observed. 

A Swiss start-up company, Sensimed (Lausanne), has 

developed a novel technology for addressing this problem, 

according to Dr. Matteo Leonardi, founder/chief technical 

officer. The device consists of a soft disposable contact 

lens with a micro electromechanical sensor embedded in it, 

which allows the measurement of corneal deformation due 

to intraocular pressure. The placement is non-invasive, the 

lens is simply inserted over the eye as would be a standard 

contact lens. A telemetry microprocessor and an antenna 

are also embedded into the contact lens sensor for wireless 

power and data transfer. 

The other innovative component of the system is the 

means of collecting and storing data. This is handled by the 

contact lens sensor system, which consists of a pair of 

glasses and a pocket reader. Signals from the sensor are 

detected by the glasses and data are retrieved wirelessly 

and stored in the pocket unit. The system allows 24-hour 

continuous intraocular pressure monitoring, during which 

time the patient’s movements are unrestricted. 

Screening for glaucoma is currently performed by 

measurements of the intraocular pressure via tonometry, a 

procedure by which the amount of pressure required to 

flatten a certain portion of the eye is measured, using a 

tonometer. This standard procedure may be augmented 

with a pachymetry to measure the cornea thickness, as this 

can influence the accuracy of the pressure measurements. 

Another feature of the pathogenesis of glaucoma is the role 

of ocular blood flow. There is increasing evidence that ocular 

blood flow is involved in glaucomatous optic neuropathy 

and that unstable blood pressure and dips are linked to 

optic nerve head damage. These facts further support the 

utility of the Sensimed technology. 

While the device was developed with its clinical applications 

the foremost goal, there is a wealth of anecdotal information 

as well as examples from the literature that indicate 

strong interest on the part of the research community. Eye 

researchers interviewed for this story waxed euphoric concerning 

its possibilities for studies on both clinical and animal 

models. According to ophthalmologist Dr. Douglas 

Gregory, “I would also guess that researchers would drool 

over the prospect of getting hold of these devices.” 

Frank Liang, MD, PhD, an ophthalmologist and associate 

director for in vivo studies at Advanced Vision Therapies 

(Gaithersburg, Maryland), said, “Given the fact of circadian 

changes in intraocular pressure, continuous monitoring by 

this noninvasive device would greatly facilitate the diagnosis 

and treatment of glaucoma disease by providing a comprehensive 

data set throughout day and night.” 

A number of published studies demonstrate the potential 

applications of the Sensimed technology. These include 

investigations of the effects of the drugs brinzolamide and 

timolol during the diurnal period. 

Clearly a convenient method of measuring intraocular 

pressure during this time frame would be of great value, 

allowing a range of the different conditions and combinations 

to be evaluated. A related study investigated the performance 

of currently available ocular hypotensive medicines 

over a 24-hour time frame in patients with primary 

open-angle glaucoma. Because these studies are usually 

performed during the daytime for reasons of convenience 

and economy, the information gathered may be inadequate 

for making optimal clinical decisions. 

Separate studies revealed that pressure measurements 

taken outside the normal office hours change the peak 

pressure assessment in 69% to 75% of cases. Finally, it has 

been shown that mean peak pressure rose when measured 

when measured outside normal office hours. The combination 

of its promise as a research tool combined with applications 

in the clinic make the Sensimed technology doubly 

appealing. The contact lens could be easily modified to fit a 

rabbit, a common candidate for these experimental 

designs. This would open the possibility of the sort of studies 

that Liang suggests, without the necessity of 3 a.m. visits 

to the laboratory on the part of exhausted researchers 

(or more likely their technicians). 

The only drawback to the development of a research 

application of the monitoring system is the availability of 



118 


funding. According to Sensimed CEO Jean-Marc Wismer, 

“making a lens for rabbits will require a change in the lens 

(smaller diameter) together with some minor electronic 

adaptations. In principle it can be done fairly easily, but 

the budget associated for the necessary R&D would be in 

the range of $200,000, so we have not pursued this 

route.” 

Finally the device appears somewhat cumbersome, but 

with the operation of “Moore’s Law” (the observation that 

every 18 months the size of computers is cut in half and their 

capacity doubles) there can be little doubt that the device 

will become increasingly miniaturized and user-friendly. 






Once bankrupt SeraCare 

now profitable company 



Even in a good economy turning a company around 

from bankruptcy, Nasdaq delisting, and an SEC investigation 

to achieving profitability is no simple task. In an economic 

state as dire as the current environment – it’s nearly 

impossible. Yet, one life sciences company has done just 

that, and within only three years. 

But despite the challenges facing SeraCare Life 

Sciences (Milford, Massachusetts) three years ago, the 

company’s president/CEO and its CFO tell Medical Device 

Daily that SeraCare today is right where they always knew 

it would be. 

“I think we absolutely thought we would [achieve profitability] 

and this has been the timeline in which we anticipated 

turning profitable,” Sue Vogt, president/CEO told 

MDD. 

CFO Greg Gould added that SeraCare had to make 

some changes in its plan based on the current economic 

challenges, but ultimately, “We always knew that we could 

get this company profitable.” 

In March 2006 SeraCare reported that it had dismissed 

four of its executives and made other moves that reflect 

what it said were the discovery of “material weaknesses” in 

its internal controls. But the company’s troubles really 

began in January of that year when an investor filed suit 

against SeraCare in federal court, accusing the company of 

stock inflation. According to that complaint, SeraCare’s 

stock price fell by as much as 62% on Dec. 20, 2005, after 

the company revealed that its independent auditors had 

issued a report about deceptive accounting issues. The 

Nasdaq market subsequently delisted SeraCare’s shares. 

The company filed for bankruptcy that spring. The company 

at the time was also under investigation by the SEC. 

Vogt and Gould joined SeraCare in the summer of 2006. 

Under the new leadership, and within three years, the company 

has emerged from bankruptcy, raised money in a 

rights offering, closed the SEC investigation, and achieved 

relisting on the Nasdaq. 

This week SeraCare reported profitable operational 

and financial results for its third quarter of fiscal year 2009 

ended June 30. 

The company had a net income of $0.7 million and 

earnings per share on a basic and diluted basis of $0.04 for 

the quarter ended June 30, compared to a net loss of $0.6 

million and a loss per share on a basic and diluted basis of 

$0.03 during the same period in 2008. 

“In the third quarter of fiscal 2009, SeraCare met its 

most significant goal for the year—achieving profitability,” 

Vogt said. “The fact that SeraCare was able to turn profitable 

in the midst of a significant economic downturn 

119 

speaks to the inherent strength of our products and services 

and our position as an innovator and quality leader in 

the markets we serve. We continue to see marked improvements 

in sequential quarter over quarter revenues during 

the fiscal year and believe our focus on introducing new, 

differentiated products to the marketplace and our costcontrol 

initiatives will support ongoing profitability.” 

Among its recent corporate milestones, SeraCare notes 

that it achieved bottom-line profitability of $0.7 million as 

measured by net income for 3Q09; generated $1.8 million in 

net cash flows from operating activities for 3Q09; 

improved gross margin by seven percentage points, to 36% 

from 29%, for 3Q09 compared to the same quarter last year; 

increased Diagnostic & Biopharmaceutical Products revenue 

by 5% and BioServices revenue by 18% compared to 

the second quarter ended March 31; generated $0.8 million 

in operating income which included non-cash expenses of 

$0.3 million for depreciation and amortization and $0.3 

million for stock compensation expense during the third 

quarter of fiscal 2009; and launched two differentiated 

products – the SeraCare Human Papillomavirus (HPV) 

Genotype Performance Panel and the Accurun 632, 644 and 

676 controls. 

According to the company, the SeraCare HPV Genotype 

Performance Panel is the first product on the market to 

enable testing laboratories, researchers and diagnostic 

manufacturers to validate their entire HPV testing system, 

ensuring that testing systems can differentiate between 

high- and low-risk HPV genotypes. 

SeraCare also noted that the Accurun 632, 644 and 676 

controls are the only commercially available single-vial 

controls that allow researchers and IVD manufacturers to 

test for all cystic fibrosis mutations currently detected by 

the leading testing platforms. 

On a sequential basis, revenue for 3Q09 increased by 

$0.9 million to $11.8 million compared to the second quarter 

of 2009. Diagnostic & Biopharmaceutical Products revenue 

for the third quarter of 2009 increased by $0.4 million to 

$8.7 million compared to 2Q09 and BioServices revenue 

increased by $0.5 million to $3 million across the same 

period. 

According to the company, it had $3.7 million in cash as 

of June 30. 

Due to “external market” conditions, Vogt said, 

SeraCare did not achieve the top line growth this year that 

it had originally planned. “Without that growth we had to be 

much more aggressive in terms of focusing on streamlining 

the operations, finding ways to cut costs and balancing 

investments with rate of return.” 

Vogt said that when she and Gould joined SeraCare in 

2006 their first priority was to reorganize the company, 

restructure the balance sheet and to pay back all of the 

creditors in full, which she said was really the first big milestone 

in SeraCare’s comeback story. From there, she said, 

the company was focused on integrating itself. 



120 


In April 2006 SeraCare unveiled plans to consolidate its 

facilities and streamline operations (MDD, April 28, 2006). 

The company moved its Oceanside operations into its 

Milford plant. 

“Going forward with the market beginning to 

improve, we’re very set on making sure that we’re wellpositioned 

to get back into a growth path and take 

advantage of growth in the market as that begins to open 

up of the next couple of quarters,” Vogt said. She noted 

that SeraCare introduced new products in each of the last 

three quarters and said the company will “continue to do 

that.” 

“We’ve also managed to gain a number of new customers, 

especially in our services business for clinical trial 

support work,” Vogt added. “We’re acquiring new customers 

and expanding what we’re doing with existing customers, 

that is key to future growth.” 

Despite the economic downturn, Vogt says SeraCare 

believes there is positive momentum for its business, as 

well as some positive momentum in the market. 

“A lot of our customers with the tough economy have 

been reducing inventories and that drove down the 

demand for product . . . we believe that is leveling out now 

and becoming more normalized,” she said. 






SFC Fluidics wins $5M contract 

to make TBI diagnostic device 



SFC Fluidics (Fayetteville, Arkansas) says it has 

received a $5 million contract from U.S. Army under the 

Congressionally Directed Medical Research Program to 

develop a handheld device for rapid diagnosis of traumatic 

brain injury (TBI). The device is scheduled to begin clinical 

trials for FDA approval in the summer of 2013, the company 

said. 

“When there are concussive injuries or other brain trauma 

the brain produces certain proteins which get into the 

blood stream and those proteins can be related to the type 

and severity of the brain injury,” Calvin Goforth, president 

of SFC Fluidics, told Medical Device Daily. “So from the 

quantitative concentrations . . . of the blood proteins you 

can make diagnosis of traumatic injuries.” 

Gorforth said that quantitative is the key word for this 

type of diagnostic device because it is important to know 

how much of the protein is present. 

According to the company, more than 1.5 million 

Americans suffer head injuries each year, and TBI has 

become a signature injury for U.S. troops serving in the 

wars in Iraq and Afghanistan. 

“With a suspected brain injury, every second counts,” 

said Dr. Chris Evans, VP of SFC Fluidics. “We are developing 

a first-of-its-kind ‘lab on a chip’ as well as associated handheld 

instrumentation to revolutionize the way military and 

civilian medics diagnose and treat traumatic brain injury.” 

Using only a pinprick sample of blood similar to a 

blood glucose test for diabetes, the device is designed to 

conduct rapid, detailed blood analysis within a single 

sealed, disposable chip. Quantitative levels of specific biomarkers 

released by the brain when injured will be displayed 

on an easy-to-read screen, along with an indicator 

alerting the operator to the degree of injury – none, mild, 

moderate or severe, the company said. 

Goforth said that ultimately the device would be used 

in the field – both on the battlefield for triage decisions and 

during sporting events, such as football games, to determine 

if an injured player needs to be sent to the hospital or 

not. However, he added, it may be a two-step process with 

the first step being to get the device into the laboratory 

environment first. 

“It’s easier to develop a device that is in the laboratory 

because the constraints are fewer [compared to the environmental 

challenges of using the test in the field],” 

Goforth said. 

SFC Fluidics won the $5 million contract through a 

competitive process. Goforth said the U.S. Army Medical 

Research Acquisition Activity office in Fort Detrick, 

121 

Maryland released a request for proposals which attracted 

“many hundreds of proposals.” Only about 3% of those proposals 

were selected, including SFC Fluidics’, he said. 

“Obviously for a field deployable device size and 

weight and automation are all key, that’s where SFC 

Fluidics’ strengths are; we have unique technologies that 

allow us to do things on [a smaller scale],” Goforth said. 

“That’s why we won the award and that’s where our real 

strengths are.” 

According to the company the device can be used by 

first responders without any specific training or medical 

expertise, and the information will assist caregivers in 

quickly choosing the proper course of action for the patient 

in combat situations, at the scene of an accident, in an 

emergency room or at a sporting event. The device and 

chip also will provide real-time information about the effectiveness 

of intervention strategies with successful treatments 

resulting in a return of biomarker indicators to normal 

levels, SFC Fluidics noted. 

SFC Fluidics is a privately-held company in the emerging 

market for microfluidic devices. 





122 

Shape-HF offers easier testing 

method for CRT therapy patients 

By OMAR FORD 


Shape Medical Systems (St. Paul, Minnesota) is offering 

a much simpler and less intensive way of testing for 

measuring ventilation parameters for patients who have 

suffered from cardio-illness. 

The Shape HF Cardiopulmonary Testing System was 

given FDA approval at the end of March and objectively 

measures CRT response in real time while the patient is 

exercising, according to Shape Medical. Objectivity is the 

key selling point of the device. 

“Typically patients are given questionnaires or surveys 

– more subjective means to test for CRT responses,” 

Clarence Johnson, president/COO of Shape Medical told 


Here’s how the device works. As the patient exercises 

at a steady state heart rate, the physician adjusts therapy 

settings every two minutes, enough time for the adjustments 

to be reflected in breathing physiology. At the end of 

the test, during which four to five therapy settings are tested, 

the Shape-HF System uses a proprietary computer algorithm 

to rank the physiological response to exercise at 

each setting. The physician then reviews the results and 

chooses the therapy setting he or she believes is most 

appropriate for the patient. The exercise includes walking 

on a treadmill at a very low intensity of one mile per hour 

with the treadmill set at a 2% grade. 

“Other methods have proven to be very difficult for 

patients,” Johnson said. “The Gas inhalation test for example 

is very difficult and has often found to bring patients to 

the point of exhaustion.” 

CRT is a widely used method for treating patients with 

severe heart failure when alternative treatment options 

have been exhausted. According to Dr. Abraham Kocheril, 

professor of medicine and director of Clinical 

Electrophysiology at the University of Illinois at Chicago 

where the Shape-HF System has already been installed, 

“The CRT response rate in heart failure patients is about 

70%. The Shape-HF System is likely to help us get the 

remaining 30%—those we call non-responders—feeling 

better.” 

Johnson added that because patient breathing efficiency 

is so sensitive to changes in CRT settings, using gas 

exchange parameters to assess these changes provides a 

completely objective method for defining response to CRT 

therapy. Plans call for the company to try and get approval 

in Europe. 

“We don’t have CE mark yet. This is a device that will 

have a wide appeal in Europe,” Johnson said “But we 

thought we would go after the domestic market first.” The 

company stressed that the Shape-HF System is the only 


device that objectively measures CRT response in real time 

while the patient is exercising. The system is cost effective, 

easy to use, and the test is easy on the patient. “It’s very 

easy to use and training for the system can be done in 30 

minutes to an hour,” Johnson told MDD. “All of the muss and 

the fuss are taken out of the process.” 

To date this is the only product the five-year-old company 

has released. 

CRT is used in severe cases of heart failure to restore 

synchrony between the heart chambers—the atria and two 

ventricles—during the heartbeat. In patients with advanced 

heart failure the heart may not beat strongly enough to 

supply adequate oxygen to peripheral tissues, and poor 

blood flow to the lungs disrupts the process of exchanging 

needed oxygen for carbon dioxide, a waste product of normal 

metabolism. 

Combined, these effects lower the amount of oxygen in 

the blood, which decreases the patient’s ability to exercise 

and causes inefficient, labored breathing. Typically shortness 

of breath on even mild exertion is a key symptom in 

heart failure during CRT therapy. The company said that a 

positive response to CRT therapy improves breathing efficiency 

during exercise, and that it makes sense that parameters 

that can measure patient breathing efficiency, can be 

used to determine the proper CRT settings. 






Mayo Clinic study validates 

accuracy of Shape-HF test 



For years the gold standard cardiopulmonary exercise 

testing has been an important method for assessing prognosis 

in heart failure patients. But according to Clarence 

Johnson, president/COO of Shape Medical Systems (St. 

Paul, Minnesota), that gold standard method is “very, very 

hard on the patient, it’s a tough test to interpret, specialized 

training is required, it’s very costly, [and] it’s done in specialized 

centers.” So, Shape has designed a device that it 

hopes will offer doctors a better alternative to assess heartlung 

interaction in patients with chronic heart failure and 

other cardiopulmonary disease. 

“The system is called Shape-HF cardiopulmonary testing 

system, and it’s unique in that it takes a very complex 

diagnostic and risk assessment tool and makes it very simple,” 

Johnson told Medical Device Daily. 

The Shape-HF system received FDA clearance in April. 

Johnson, who spoke to MDD from the Minneapolis Heart 

Institute on Friday where patients where being tested on 

the Shape-HF, said the system is small and simple enough 

to be used right in the doctor’s office. 

Shape says a recent Mayo Clinic (Rochester, Minnesota) 

study validates the measurement accuracy of its Shape-HF 

system. Data collected by the system compared favorably 

to that of the Mayo Clinic Cardiopulmonary Research 

System and reflected a tight reproducibility of the results, 

the company noted. 

The study involved testing 22 subjects simultaneously 

on the Shape-HF and the Mayo Clinic Cardiovascular 

Research System. Pneumotachs, providing air flow to the 

respective test systems, were connected in series for the 

tests. The order of the pneumotach for each system was 

alternated for two test runs separated by 15 minutes of rest. 

Each subject was tested at rest and as power was increased 

on a cycle ergometer to 50 Watts, 70 Watts and 125 Watts, 

with three minutes of exercise at each exercise work rate. 

The last 30 seconds of data for each interval for each 

run was then averaged. The averages of all subjects for rest 

and the three exercise intervals were then averaged for 

each run. According to the company, the average values for 

each run showed a “remarkably consistent” parallel and 

match for all measurements, which included heart rate, 

oxygen uptake, carbon dioxide output, tidal volume, endtidal 

partial pressure of carbon dioxide, oxygen saturation, 

and breathing frequency. Prior to each test run, the Mayo 

system was calibrated manually; the Shape-HF was calibrated 

automatically using its dynamic autocalibration feature 

that does not require manual calibration prior to testing, 

Shape said. The company added that a manuscript 

detailing the study is in development and will be submitted 

123 

for publication. 

The study validated that the system works, which is 

important, but most importantly it defines reproducibility, 

he said. 

“It was not a study designed to answer clinical questions, 

it was designed to answer whether or not these 

parameters are reproducible and it turns out they are very 

reproducible,” Johnson said. He said that was a benefit for 

the company, but also for the physicians because it helps 

them understand that they can rely on the integrity of the 

test’s outcome. 

Unlike CPX testing which is done at maximal exercise 

effort, which Johnson said is very difficult for heart failure 

patients, the Shape-HF test is done at submaximal exercise 

effort. The patient doesn’t have to exercise to any given 

level of effort so they can be comfortable while doing it, he 

said. The test takes about six minutes, only three minutes 

of which are exercise, he said. 

Johnson said the Shape-HF system enables “serial testing 

on patients so physicians can have a good look at 

what’s happening physiologically with the patient over 

time.” That’s “unique in heart failure management today,” he 

added. 

According to the company, Shape-HF is the first gas 

exchange-testing device specifically designed for cardiology. 

Shape-HF quantifies the severity of dyspnea on exertion 

and fatigue and evaluates the interaction between the 

heart, lungs, and other organ systems. This makes it possible 

for the physician to evaluate therapy options for the 

individual patient and track patient progress, Shape said. 

The company added that the Shape-HF provides real-time 

physiological assessment to help physicians optimize cardiac 

resynchronization therapy at exercise levels consistent 

with patient daily activity. 





124 

New stent for tough-to-treat 

coronary artery bifurcations 



Interventional cardiologists have long been challenged 

by coronary artery bifurcation lesions – branches or forks 

in the arteries – because treating those areas is associated 

with an increased risk of heart attack, restenosis and death. 

Three-year-old Stentys (Princeton, New Jersey and Paris) 

has just received a CE mark for what it says is the very first 

stent system that’s disconnectable and-self-expanding, a 

platform specifically designed to treat coronary artery 

bifurcations. 

“Regular stents are made of steel that are like little 

metallic tubes that don’t move,” Stentys CEO Gonzague 

Issenmann told Medical Device Daily. “Our stent acts as a 

spring. This is the novel part. Other stents are not selfextending. 

They stay where they are. The Stentys platform 

combines those two novel features (disconnectable and 

self-expanding). That’s unrivaled in this space and caters to 

the specific needs for difficult and challenging situations 

for the cardiologist.” 

The disconnectable feature allows cardiologists full 

access to a side branch of the artery and placement of a 

second stent. “You can’t fit a tube into a Y branch,” 

Issenmann said. “The procedure used today to treat with 

regular stents is well known and accepted. It’s a provisional 

stenting technique for bifurcations where you put a regular 

stent in main branch and try to find your way into the 

side branch. It doesn’t scaffold well and you need to do a lot 

of ballooning. These techniques force the cardiologist to 

treat the side branch first and that’s counterintuitive 

because they want to treat the most important vessel first. 

“We propose something that has the advantage of 

keeping that same technique, but it’s made easier by the 

disconnection feature that allows the cardiologist to open 

up the stent without distorting it. The advantage is that you 

use the same routine except that when you embark in the 

procedure, you can decide whether you want to access the 

side branch or not,” he said. 

The Stentys stent actually looks like it has a side door. 

The self-expanding feature ensures optimal apposition in 

the critical initial hours and days after an acute myocardial 

infarction (AMI) procedure, according to the company. It’s 

constantly applied to the vessel surface during thrombus 

and vessel spasm relief, therefore avoiding malapposition, 

a significant concern to cardiologists. Although the CE 

mark was issued in connection with the bifurcation indication, 

Issenmann said it’s also specifically designed for AMI 

procedures. 

“It’s built with special titanium alloy that gives the stent 

properties to act as a spring and can expand and push on 

vessel walls,” he said. “Patients who suffer from AMI are 


brought to the cath lab and basically they are there to 

reopen and recreate the flow with a stent,” he said. “The 

problem is they are using stents designed to treat blockages 

of the coronaries that occur over time. They are not 

the ones that occur acutely. 

When you have this clotting of the artery that occurs 

immediately, you have a chain reaction in the artery; clots 

and spasms make it smaller. With a regular stent, you have 

a problem with sizing. The stent is often not properly 

apposed to the vessel wall. This is one of the biggest predictors 

of reclotting later on – because it wasn’t properly 

placed where the initial clot was.” 

Issenmann said the Stentys stent “allows for perfect 

apposition of the stent to prevent malapposition and 

recurrence of clots. Only a self-expanding stent can do 

that.” He added that the stent ultimately reduces the potential 

for restenosis. 

To obtain the CE mark, Stentys used data from its OPEN 

I (First-In-Man study of the Stentys Coronary Bifurcation 

Stent fOr the Percutaneous treatmEnt of de-novo lesions in 

Native bifurcated coronary arteries) study. Forty patients 

were enrolled in OPEN I between September 2007 and 

September 2008 at nine European clinical sites. 

The prospective, non-randomized, single-arm, multicenter 

safety and feasibility study found that it was safe, 

doesn’t fracture over time, has results similar to balloonexpandable 

bare metal stents, provides excellent crossover 

treatment of bifurcations, the stent remained perfectly 

opposed to the treated vessels and there were no deaths 

or reoccurrence of heart attack during the six-month follow-up 

period. The company intends to start commercializing 

the stent in Europe during the first half of 2010 and has 

started discussions with FDA, although no U.S.-based studies 

are yet planned. 

Stentys is currently conducting another trial with the 

same stent seeking CE mark for the AMI indication. Another 

larger study will begin later this year that will compare the 

Stentys stent with a balloon expandable stent. Stentys last 

month managed to secure the second tranche of a Series B 

financing, closing an additional $4.2 million investment 

from new investor bringing the total B round financing to 

more than $22 million (MDD, June 30, 2009). 

“Basically the proceeds of this are good toward the continuation 

of our clinical program,” Issenmann said. “We 

actually raised more than expected, so that gives us even 

more runway. In all fairness, we were fortunate. When I hear 

war stories about what’s going on in the U.S. to raise 

money, I know we have an advantage of being on both 

sides of the ocean.” 

Stentys was co-founded by Issenmann and Jacques 

Séguin, MD, founder of CoreValve, a company acquired earlier 

this year by Medtronic (Minneapolis) for $700 million. 






C-Pulse implanted in first 

two U.S. female patients 



When Sunshine Heart (Tustin, California) sought an 

investigational device exemption (IDE) from the FDA last 

year to begin a feasibility trial of its C-Pulse heart assist 

device, the agency asked the company to pay special attention 

to female heart failure patients, CEO Don Rohrbaugh 


“Even though half of the heart failure patients are 

women, in most clinical trials only 20% to 25% of enrollees 

are female,” Rohrbaugh said. 

Thus, the fact that one of the six sites participating in 

the company’s trial, Jewish Hospital (Louisville, Kentucky) 

has completed implants of its C-Pulse heart assist system in 

two female patients, ages 55 and 58, respectively, is a significant 

milestone for the device, Rohrbaugh said. He noted 

that heart failure affects about 2.5 million women in the 

U.S.. The women were the first U.S. female patients treated 

with the C-Pulse device and they were the first two patients 

to receive the device at Jewish. Sunshine has treated a total 

of four patients thus far in the trial. 

“C-Pulse can be an important new therapy for women 

suffering from heart failure since they typically survive 

longer than men with the disease but commonly have more 

illness, more frequent hospitalizations and a poorer overall 

quality of life,” Rohrbaugh said. 

The company received conditional approval from the 

FDA last year to begin the trial under an IDE. In April, the 

company reported that it had completed the first two 

implants of the device under the 20-person trial. 

As for why women are typically underrepresented in 

heart failure trials, “it’s a little bit of a puzzle,” Rohrbaugh 

said. “Generally women have heart failure a little bit later in 

their life, although there are some women that get into 

heart failure early in life with postpartum heart failure . . . 

there is some feeling that women don’t recognize their 

symptoms as much as men, they go through hormonal 

changes which they attribute for their symptoms . . .” 

Another possible reason, he offered, is that women 

have a higher sensitivity to certain cancers, such as breast 

cancer, and therefore they may be less sensitive to the 

symptoms of heart failure. In any case, Sunshine Heart is 

making a concerted effort to ensure its trial represents a 

balance of men and women. 

“On a whole, we’ve encouraged our sites to deliberately 

look for women maybe a little more carefully than they 

might have otherwise,” Rohrbaugh said. 

At Jewish, Mark Slaughter, MD, professor of surgery 

and chief of the Division of Thoracic and Cardiovascular 

Surgery at the University of Louisville, implanted the C- 

Pulse into the first two female patients. Slaughter also 

125 

serves as the director of the Heart Transplant and 

Mechanical Assist Device program at Jewish Hospital and 

the University of Louisville and is the associate medical 

director of the Cardiovascular Innovation Institute 

(Louisville). 

“It is an honor to have completed the first U.S. implants 

of the C-Pulse heart assist system in female heart failure 

patients,” Slaughter said. “C-Pulse is highly innovative and 

implanted with a simple, low-risk minimally invasive surgical 

procedure. The device has the potential to offer a new 

therapy option for the treatment of advanced heart failure.” 

According to the company, the C-Pulse is an 

implantable, non-blood contacting, heart assist therapy for 

the treatment of people with moderate heart failure. The 

device is designed to reduce the symptoms of heart failure 

through the use of counterpulsation technology, which 

enables an increase in cardiac output, an increase in coronary 

blood flow and reduction in the heart’s pumping load. 

“In moderate heart failure, they’re not sick enough for a 

heart transplant, they’re not sick enough for an LVAD . . . 

with our C-Pulse, it’s a simple implant, non-blood contacting, 

patients don’t have to go on anticoagulation drugs,” 

Rohrbaugh said. “And because it’s outside the blood stream 

and easy to implant it’s a lower-risk procedure, lower-cost 

procedure, so that makes it attractive to the medical community 

– to treat these patients a little earlier, maybe give 

them a better quality of life.” 

According to Sunshine Heart, a major medical treatment 

challenge is that the medical regimen and CRT 

options often stop alleviating symptoms over time, hence 

the need for the C-Pulse. 

“We are excited to be a part of the C-Pulse clinical trial 

in the U.S.,” said Sumanth Prabhu, MD, professor of medicine 

and physiology and director of Heart Failure at the 

University of Louisville and co-principal investigator of the 

trial at Jewish Hospital. “The C-Pulse system is a novel 

device that increases blood flow to the body and to the 

heart muscle itself without coming into direct contact with 

the blood. Consequently, the risk of stroke and embolism 

appears to be negligible and blood thinning medication is 

not required.” 

Prabhu’s research centers on understanding mechanisms 

underlying heart failure, Sunshine Heart noted. 

In addition to Jewish and Ohio State, the 20-patient feasibility 

trial is being undertaken at four other U.S. medical 

institutions: Northwestern Memorial Hospital (Chicago), 

Hershey Medical Center (Hershey, Pennsylvania) of the 

Pennsylvania State University, University of Florida School 

of Medicine (Gainesville) and University of Alabama/ 

Birmingham Medical Center. 





126 

FDA approves Aixplorer for 

novel cancer diagnostics 



PARIS — A novel diagnostic tool for detecting and characterizing 

tumors that promises to revolutionize screenings 

for breast and prostate cancers has been cleared for 

commercialization in the U.S.. 

SuperSonic Imagine (Aix-En-Provence, France) 

reported it received 510(k) approval from the Food & Drug 

Administration (FDA) for Aixplorer, an ultrasound system 

that combines a high-end B-mode ultrasound with an innovative 

shear wave modality capable of measuring tissue 

stiffness or elasticity. 

Shear wave is a sophisticated enhancement for the 

tried-and-true medical exam technique called palpitation 

where the doctor presses a patient’s skin to feel for stiffness 

of a liver or a breast lump. 

This first line exam is based on the good sense that 

supple tissue is healthy and stiff tissue is not. 

Shear wave technology takes the palpitation test to a 

new level by providing quantifiable data to characterize the 

tissue, which combined with high quality B-mode images, 

enables radiologists to diagnose the nature of a tumor. 

Current screenings for breast cancer, for example, rely 

on X-ray exams followed by biopsies of any suspect tissue 

to characterize and diagnose tumors. 

Shear wave exams potentially could eliminate several 

steps and costly imaging procedures by providing a onestep 

detection and tissue characterization exam, enabling 

physicians to more precisely target lesions requiring a 

biopsy. 

Such exams could reduce the number of biopsies, 

another potential cost savings, and also provide more 

immediate results for patients who today must wait weeks 

to hear whether a suspected tumor is malignant or benign. 

While several companies provide ultrasound elasticity 

exams using a compression method, where the scanner 

operator presses down on tissue to create a sonic wave to 

measure tissue stiffness, Aixplorer is the only FDAapproved 

device that produces a pulse with its transducers 

to create the same effect (Medical Device Daily, March 13, 

2009). 

Jacques Souquet, the founder of SuperSonic, dismisses 

the operator compression technique as highly dependent 

on the skill level and experience of a given operator, and 

therefore not clinically reliable as results are not reproducible, 

even by the same operator with a second exam. 

Compression ultrasound provides “only a global 

assessment of deformation where shear wave pulse provides 

a local assessment of specific lesion stiffness,” he 

said. 

A demonstration of the Aixplorer platform featuring 


the proprietary ShearWave, which renders tissue images 

200 times faster than conventional ultrasound and produces 

a color-coded map of breast lesions, was first given 

at the Radiological Society of North America meeting in 

Chicago in December, 2008. 

“Since we introduced Aixplorer there has been a great 

deal of anticipation for its FDA approval,” said Souquet, who 

adds that “elastography is the next level and the future of 

ultrasound,” 

The market potential for Aixplorer in the U.S. is significant 

according to Edward McClenny, Supersonic’s General 

Manager for the Americas. 

“We’ve talked to hundreds of doctors and sonographers 

and it is the combination of a spectacular image quality 

and the potential for ShearWave elastography that is 

driving the excitement,” he said. 

The company received its CE mark in early 2009 and 

began shipping Aixplorer units in April. 

“Our sales funnel has exceeded our expectations for 

the first three months of this year and we are building up 

the capacity to meet this kind of demand,” he told MDD. 

SuperSonic is currently completing a study of breast 

exams using shear wave across 15 medical centers, including 

seven in the U.S. and 10 in Europe. 

The endpoint for the study is to demonstrate the specificity 

of the shear wave exam in detecting tumors. 

“In the United States there are two million breast biopsies 

performed each year, yet 80% of these biopsies return 

negative results,” said Souquet. 

“That is a heavy cost to the healthcare system so if we 

are able to clinically demonstrate that we can reduce the 

number of biopsies required, that could represent significant 

savings,” he said. 

Physicians at Hammersmith-Charring Cross Hospital 

(London), who are participating in the Supersonic study, 

estimate the reduction in biopsies could be as high as 50%, 

he said, while partner hospitals in the U.S. are more conservative 

saying it could be reduced by 30% to 40%. 

“If we demonstrate the effectiveness for breast examinations 

we plan to move on to the prostate and the liver,” 

Souquet said. 

Earlier this year, the French innovation funding agency 

OSEO invested 8.5 million ($11 million) in a collaboration 

between Supersonic and Paris-based Theraclion to develop 

a novel treatment for hyperparathyroidism with real-time 

imaging of the therapy. 

The TUCE project (Traitement Ultrasonore Controllé 

Elastrographie) combines Theraclion’s Thyrus stereotactic 

targeting for HIFU (high-intensity focused ultrasound) with 

the Aixplorer from Supersonic measuring tissue elasticity 

(MDD, Feb. 12, 2009). 






superDimension’s iLogic locates 

lung spots previously unreachable 



Treatment for diseases of the lungs, particularly cancer, 

is undergoing a technology shift that’s analogous to the 

early days of angioplasty: Electromagnetic navigation 

bronchoscopy (ENB) is helping physicians to reach lesions 

deep in branches of the lungs in a minimally invasive fashion. 

It helps patients avoid diagnostic surgeries and early 

death. 

superDimension (Minneapolis) has just launched the 

iLogic System, which allows an interventionalist to more 

safely access lesions via a bronchoscope down the throat, 

rather than through open chest surgery (thoracotomy) or 

even needle aspiration, procedures that both carry significant 

risks for the patients who are eligible. A much broader 

patient population is eligible for ENB than than other procedures. 

“What’s happening right now is that the medical community 

is discovering the superDimension procedure literally 

within the last year,” Daniel Sullivan, president/CEO of 

superDimension, told Medical Device Daily. “For years the 

medical institutions looked at patients with spots on their 

lungs as almost lost in space because their only option was 

a very invasive biopsy. Millions of patients went on watchful 

waiting.” 

For those whose lesions were cancerous, watchful 

waiting meant waiting for death. 

Since lung cancer is the leading cause of cancer death 

for both men and women, diagnosing and treating it at earlier 

stages is paramount to putting the brakes on a disease 

that kills more people than colon, breast and prostate cancers 

combined. 

In sync with this new product launched, the American 

Medical Association (AMA; Chicago) has just issued a new 

Category I CPT code for the use of superDimension’s ENB 

device to navigate to lesions or spots deep in the lungs. The 

code will become effective Jan. 1. The AMA also issued a new 

CPT I code for the placement of fiducial radiosurgical markers 

via the ENB procedure. 

ENB is performed on an outpatient basis and starts with 

a catheter inserted through the throat or nose. If the targeted 

lesions are determined to be cancerous, a pulmonologist 

can use ENB to transbronchially place radiosurgical 

markers in and around the lesions to help radiation oncologists 

treat patients with external beam radiation. The procedure 

typically leaves the patient with no more than a sore 

throat. 

Prior to ENB, the gold standard to diagnose lung cancer 

was one of two invasive surgeries: wedge thoracotomy 

(open chest partial lung removal) to biopsy the lung and 

mediastinoscopy (invasive lymph node surgery) to biopsy 

127 

the lymph nodes. Patients with poor lung function who 

could not tolerate these more invasive procedures, or those 

with comorbidities, were left with watchful waiting as their 

only option. 

superDimension appears to be the only player in this 

emerging field. The company launched a predecessor to 

iLogic two years ago called inReach. iLogic improves on 

that design, offering a simplified positioning and navigational 

system that improves ease of use and further 

enhances visualization for the pulmonologist. 

“The previous system had three screens and the doctor 

would watch those three and make an interpretation in his 

head on where the tip of the catheter was,” Sullivan said. 

“Our new system no longer forces him to make that 3-D 

interpretation. It’s on the screen now. They can see blood 

vessels, lungs, airways. It gives them all the information 

they could want in terms of visualizing a lung lesion.” 

superDimension debuted the iLogic system at the 

recent American College of Chest Physicians (CHEST; 

Northbrook, Illinois) annual meeting in San Diego and the 

American Society for Radiation Oncology (ASTRO; Fairfax, 

Virginia) Conference in Chicago. 

The 3-D improvements in the iLogic system include a 

new software platform with a simplified positioning and 

navigational system. The virtual 3-D bronchial tree made 

possible with the technology extends deep into the lungs 

reaching more than 17 airway generations. Additionally, 

customized high-definition views available with iLogic 

offer physicians multiple navigation perspectives to 

improve detection and diagnosis. A 26-inch high-definition 

wide screen format allows six viewports to be displayed 

simultaneously, including one video input, enabling the 

physician to evaluate positional data and optimize central 

and peripheral guidance within the lung. 

Surgeons generally needed 1.5 days of training on the 

inReach system, but with the new 3-D features, that training 

period is reduced for iLogic. 

“As medical professionals become more comfortable 

and familiar with ENB, we believe the introduction of iLogic 

will further ignite enthusiasm for adoption of the system 

and ultimately, improve patient outcomes,” Sullivan said. 

ENB has FDA 510(k) clearance in the U.S., CE mark in 

Europe and it has also been approved for use in Australia 

and Canada. Sullivan said that more than 9,000 patients 

have undergone ENB and 200 systems are in use worldwide 

with 150 in the U.S. 

iLogic is priced at $153,000 and catheter systems are 

$1,000 for each patient. 

Sullivan said it took three years to obtain the CPT code 

and he now expects private insurers to follow suit as the 

company’s flagship product is used at more hospitals. 

superDimension, he said, is sufficiently funded at present, 

but “No small, private company ever has enough funding. 

We’re in pretty good shape with a strong group of venture 

capital investors and some very large institutional 



128 


investors. We are contemplating another funding round in 

4Q of this year.” 

Moving forward, he envisions the application of iLogic 

to other lung diseases, such as asthma, chronic obstructive 

pulmonary disease and interstitial disease. 

“Our current focus is lung cancer because it’s the 

largest cancer killer,” he said. “Long term survival is just 15%. 

Our opportunity is to be able to diagnose and facilitate 

treatment in the earliest stages when you still have an 

opportunity to dramatically increase survival rates.” 






SynergEyes to launch ClearKone 

lenses geared toward keratoconus 

By OMAR FORD 


Keratoconus patients, those suffering with a cone 

shaped corneas, often have difficulty with wearing contacts. 

Trying to find the right kind of lens that will fit is 

often difficult and frustrating for some patients. But a small 

West Coast-based med-tech company is offering a contact 

lens that is promising to give these patients some relief. 

SynergEyes (Carlsbad, California) reported that it has 

introduced a new advanced lens design for keratoconus 

patients in the form of ClearKone. It’s what the company 

calls “a revolutionary contact lens” that takes advantage of 

the best features of the hybrid platform, providing superior 

visual acuity, centration, stability, and all-day comfort. 

SynergEyes lenses are the only FDA-cleared hybrid contact 

lenses specifically designed for keratoconus vision correction, 

the company said. 

The lenses are available in 130 locations in the U.S. and 

there are plans to add 250 more starting in September, 

Kellie Kaseburg, VP of Global Marketing for SynergEyes told 


SynergEyes recognized the need to develop a hybrid 

contact lens design that could fit a much broader spectrum 

of keratoconus patients, including oval cones, highly 

advanced central cones, decentered cones and depending 

on the specifics of the case, globus keratoconus and pellucid 

marginal degeneration,” Kaseburg said. “The ClearKone 

lens does just that and will allow many more keratoconus 

patients to experience the benefits of hybrid technology.” 

The ClearKone lens uses hybrid technology to give keratoconus 

patients visual clarity of a high-oxygen rigid gas permeable 

contact lens and the all-day comfort and convenience 

of a soft lens. What makes the ClearKone lens different 

from other SynergEyes lenses is the design of the lens 

itself and the technique used to fit it, the company said. 

The patent-pending design is optimized to vault the 

predominant irregularities of the keratoconic cornea, thus 

effectively restoring vision to a vast majority of irregular 

cornea patients, without compromising comfort or eye 

health, even in difficult cases. 

“In the past there just weren’t a lot of great options for 

keratoconus patients,” Kaseburg said. “Some solutions had 

patients wearing two contacts in one eye and you can 

imagine how problematic that would be. To design a lens 

like this . . . that’s always been a goal of the company.” 

SynergEyes received a huge boost to its coffers earlier 

this year that partly went into funding research and development 

of the ClearKone lenses. Back in February the company 

closed in on $13.3 million Series C financing. De Novo 

Ventures (Palo Alto, California) led this round as well as 

SynergEyes’ Series B round. Bio-Star Private Equity Fund 

129 

(Petoskey, Michigan) joined Series A and B investors Alloy 

Ventures (Palo Alto, California), Delphi Ventures (Menlo 

Park, California), InnoCal Venture Capital (Costa Mesa, 

California) and Windward Ventures (San Diego) as new 

investors. 

The company also launched a hybrid contact lens 

designed for those who need further vision correction after 

undergoing refractive vision surgery (MDD, March 3, 2008). 

SynergEyes PS (post-surgical) is also designed for people 

who have experienced some type of corneal trauma or suffer 

from certain degenerative vision conditions. The contact 

lenses combine two materials — a rigid gas permeable 

center with a soft lens outer skirt. The hybrid design bonds 

a hard and soft contact lens together, resulting in a vision 

correction option the company said provides “crisp, clear 

vision for surgically altered corneas in a comfortable, 

healthy contact lens.” 

SynergEyes was founded in 2001 and is mostly funded 

through venture capital firms. It offers three other lenses 

with FDA approval that include SynergEyes A, a lens for naturally 

occurring ametropia, targeting patients with astigmatism, 

current gas permeable lens wearers and patients 

demanding optimized vision; the SynergEyes KC for keratoconus; 

and the SynergEyes Multifocal lens for presbyopia. 





130 


TBI launches Ocular services 

to replace tissue, info segment 


TBI/Tissue Banks International (Baltimore) reported 

it has developed an Ocular Services Division to replace 

the Tissue Distribution and Information Center at the 

organization. 

The group will continue to provide a high level of customer 

service to ophthalmic surgeons, as well as coordinate 

the exchange of information between recovery partners 

and TBI operations divisions. 

TBI Ocular Services will lead a new program that 

emphasizes local customer service, using TBI’s network of 

recovery partners and affiliates to implement follow-up in 

the field. This gives surgeons across the country the opportunity 

to have in-depth, face-to-face communications with 

TBI to ensure we are meeting their tissue needs. 

New communications and customer relationship management 

tools will allow TBI Ocular Services to improve the 

level of service offered to TBI’s global network of customers. 

For example, new and enhanced follow-up procedures 

will extend the opportunity for surgeons to provide 

more detailed feedback to TBI. A focus on one-on-one interaction 

between surgeons and Ocular Services representatives 

will provide more reliability for customers and lead to 

stronger customer relationships. 

The unit will be led by Sameera Farazdaghi, who has 

extensive experience in eye banking, and has held various 

positions at other eye banking organizations and with TBI. 

She holds a Bachelor of Science in Microbiology and a 

Master of Public Health. 




New artificial heart may have 

continuous, pulseless blood flow 



Can a human survive with no pulse It’s a long-standing 

argument that one prominent heart surgeon is seeking to 

prove in his efforts to develop a total artificial heart that 

produces a continuous, pulseless blood flow. 

The future of artificial heart development to treat people 

with deadly congestive heart failure may lie in this simpler 

design one that eliminates the need for a pulse. 

“Since the introduction of the heart/lung machine, 

there’s been controversy about how important a pulse is 

for circulation,” said O.H. Frazier, MD, chief of 

Cardiopulmonary Transplantation, chief of The Center for 

Cardiac Support, and director of Surgical Research at Texas 

Heart Institute (THI; Houston) and director of Transplant 

Service at St. Luke’s Episcopal Hospital (Houston). 

“My position is that the only thing that needs a pulse is 

the heart itself,” he told Medical Device Daily. “The blood 

that is delivered everywhere else pulseless. This was an 

ongoing debate. But more and more, we’ve gotten interested 

in continuous flow because it offers an opportunity to 

replace function of the heart with a device that’s much 

more user friendly than pulsed devices.” 

Frazier, who is reported to have performed more heart 

transplants than any other surgeon in the world – 1,000+ – 

said the big advantages of this proposed cardiac device are 

size, durability and cost. The National Institutes of Health 

(NIH; Bethesda, Maryland) has just awarded THI a $4.1 million 

grant so that Frazier and his team can continue their 

work to determine the effects of pulseless blood flow on 

bodily functions. 

Continuous flow pumps were first introduced for partial 

support of failing hearts, but they have never been used 

for total heart replacement. Currently available artificial 

hearts are expensive, often too big to fit most patients and 

last just a few years. 

“A continuous, pulseless blood flow heart, we think, will 

last 15-20 years,” he said. “There are no valves, so it’s potentially 

much less expensive.” 

Frazier has been working on hearts since he as a medical 

student in the 1960s. Just two years ago, he took a heart 

out of a calf and replaced it with continuous pumps. 

“The animal woke up fine,” he said. “Since that time, 

we’ve been very interested in it as a total artificial heart 

131 

replacement. It’s been very gratifying that these experimental 

animals tolerate this very well. Hopefully we can 

learn much more. We do think there is a need for long-term 

reliable cardiac replacement that will render a patient capable 

of living a normal life.” 

In the new THI study, calves’ or sheep’s hearts will be 

replaced with two small, continuous flow blood pumps that 

operate according to the principle of centrifugal force. 

Compared to existing assist devices, the new total artificial 

heart will function more like a natural heart, in that it can 

adjust how much blood it pumps depending on how much 

blood is in the heart. 

Being able to assess how the device responds to the 

body’s changing needs for blood is a key objective of the 

study. 

“We’re working with engineering groups to see if we 

can determine some way of working on responsivity of the 

pumps,” Frazier said. “The other advantage of continuous 

flow pumps is that their flow is increased by increasing 

inflow pressure much like the native heart, which only 

increases output if it needs more blood. These pumps will 

do the same. There are instances where we’d like to 

increase the RPM. In clinical pumps we’ve used, we could 

only run them at a fixed rate and haven’t cracked the code 

on that yet. We’re also going to look at microcirculation in 

non-pulsatile animals.” 

He said a pulse may be necessary for some people, particularly 

those with atherosclerosis. 

“They may need a pulse to wash out the blockages in 

the arteries,” he said. “By varying the speed, we could 

induce a pulse. In this study, we may be able to come to 

some conclusion about the role and utility of inducing pulsativity. 

The effects on the arteries will be studied.” 

Frazier said that, until a few years ago, nobody else was 

working on this theory. After a presentation of his early 

findings at a medical conference, four other groups have 

since emerged that are working on the same theory, one 

the U.S. at the Cleveland Clinic as well as teams in Japan, 

Berlin and Australia. 

“People are skeptical at first, but once they realize to 

possibilities, everybody wants to get involved,” he said. “It’s 

important to have other people working on it. You need a 

certain critical mass of people, particularly at the outset.” 

Anecdotally, Frazier said he’s had five patients with no 

heart function supported by continuous flow pumps. They 

went into ventricular fibrillation, but were fairly well supported 

by the pumps. 

“I’ve heard of another colleague of mine who replaced a 



132 


heart with one pump and the patient is doing well. So we’ve 

already seen that it works in a physiologic sense,” he said. 

Currently, his team is using commercially available 

pumps, but new technology is needed for a total heart 

replacement. 

“These grants are not for product development, but we 

need something like what was done for LVADS [left ventricular 

assist devices] in the 1970s and 1980s,” he said. “That 

would be the next important step. I would encourage 

device makers to get involved. Nobody I know is actually 

working on it. We’ve definitely established long-term survival 

without a pulse is not only feasible, it’s desirable if 

we’re making something to replace the heart. Now the technology 

will be the next challenge.” 

In addition to his team at THI, Frazier is collaborating 

with Thoratec (Pleasanton, California), Beth Israel 

Deaconess Medical Center (Boston) and Harvard Medical 

School (Boston). 






ThermoGenesis launches Res-Q, 

expands into bone marrow market 

A Medical Device Daily Staff report 

ThermoGenesis (Rancho Cordova, California) reported 

the launch of its Res-Q 60 BMC system, an automated 

cell processing medical device for the concentration of 

bone marrow-derived stem cells at the point of care. 

The company said that the Res-Q system processes 

bone marrow in minutes and delivers a high rate of stem 

cell recovery. The Res-Q system follows the late 2008 

launch of the MXP MarrowXpress system, a laboratory 

device also used to collect stem cells from bone marrow. 

According to the company, the Res-Q system is a microprocessor-controlled 

device and has a dedicated single-use 

disposable bag set for concentrating stem cells derived 

from bone marrow. It allows clinicians to automate blood 

volume reduction and facilitates cryopreservation of 

processed bone marrow aspirates. The bone marrow concentrates 

are used in spinal fusion procedures. 

The company said it plans to initially target the orthopedic 

regenerative medicine market through its orthopedic 

distribution partner Celling Technologies a subsidiary of 

SpineSmith (Austin, Texas). Celling is distributor of orthopedic 

products and also serves as a distributor of the MXP 

System. 

ThermoGenesis and Celling also reported an expanded 

collaboration between the two firms. Separately, the 

Company plans to expand Res-Q’s applications into the 

cardiovascular and other non-orthopedic regenerative 

medicine markets. 

As part of this expanded collaboration, ThermoGenesis 

and Celling will share in the funding for clinical studies to 

demonstrate the clinical effectiveness of both the MXP and 

Res-Q systems with Celling’s orthopedic applications. 

Incremental funding for clinical studies will be provided 

by ThermoGenesis and Celling as MXP and Res-Q sales 

grow. Celling will be responsible for coordinating the clinical 

trials. 

ThermoGenesis has also launched its Res-Q system, an 

automated cell processing medical device for the concentration 

of bone marrow-derived stem cells at the point of 

care. Celling will be the distributor for the Res-Q System in 

orthopedic applications. Celling will also continue distributing 

the MXP system for the company. 

Melville Engle, CEO of ThermoGenesis, said: “Celling 

has done an excellent job of supporting the MXP and we 

look forward to working with them with the launch of Res- 

Q and with this broader collaboration agreement. We 

expect that positive study results will accelerate the market 

adoption of our bone marrow processing technologies 

and should increase product sales.” 

He added that the introduction of this device will help 

the company access the growing regenerative medicine 

133 

market in a “meaningful way”. 

“We believe our Res-Q system has considerable advantages 

over competing products and should help surgeons 

realize the true value of autologous cellular therapy,” he 

said. 

To date the company has released a wide arsenal of 

products which include: 

• The BioArchive system, an automated cryogenic 

device, is used by cord blood stem cell banks in more than 

25 countries for cryopreserving and archiving cord blood 

stem cell units for transplant. 

• AXP AutoXpress Platform, a proprietary family of 

automated devices that includes the AXP and the MXP 

MarrowXpress and companion sterile blood processing disposables 

for harvesting stem cells in closed systems. The 

AXP device is used for the processing of cord blood. GE 

Healthcare is the exclusive global distribution partner for 

the AXP cord blood product except for Central and South 

America, China and Russia/CIS, where ThermoGenesis markets 

through independent distributors. The MXP is used for 

isolating stem cells from bone marrow. 

• The CryoSea FS system, an automated device and 

companion sterile blood processing disposable, is used to 

prepare fibrin sealants from plasma in about an hour. The 

CryoSeal FS system is approved in the U.S. for liver resection 

surgeries. The CryoSeal FS system has received the CE 

mark. Asahi Medical is the exclusive distributor for the 

CryoSeal. 





134 

Transoma’s Sleuth AT compared 

against external cardio-monitors 


By OMAR FORD 


A new clinical trial seeks to determine which method of 

monitoring for post-procedure atrial fibrillation (AF) recurrence 

is more effective while comparing Transoma 

Medical’s (St. Paul, Minnesota) Sleuth AT against external 

event recorders. 

COMPLIANCE is poised to evaluate 140 patients and is a 

randomized study that is specifically designed to compare 

how the previously mentioned methods can predict and 

detect the number of patients who develop recurrent AF at 

six months, one year and two years after an AF ablation 

procedure. 

“We’re hoping that [COMPLIANCE] yields more clinical 

evidence that continuous monitoring is better than intermittent 

monitoring,” Stella Kim, Marketing director for 

Transoma Medical told Medical Device Daily. 

According to the company, external monitoring 

options provide much shorter monitoring durations or limited 

memory capacity which is not ideal when trying to 

determine appropriate ongoing therapy for my AF patients 

who have undergone catheter ablation. 

Also earlier studies have shown that conventional 

monitoring methods cannot detect AF in all cases, and that 

a prolonged duration of monitoring is required to effectively 

measure the absence or presence of AF post-ablation. 

Due to the asymptomatic and transient nature, paroxysmal 

(sudden onset) atrial fibrillation detection does not 

often occur within the bounds of the Holter monitors, event 

recorders or mobile out-clinic monitoring systems (MCOT). 

While Transoma isn’t sponsoring COMPLIANCE (that 

honor goes to Dhanunjaya Lakkiredd, MD), the company’s 

stake in the study is the effectiveness of its Sleuth AT, a 

next generation device that was given FDA clearance back 

in February and was launched in June. 

Lakkiredd who is director of the Center for Excellence 

in Atrial Fibrillation, Bloch Heart Rhythm Center (Kansas 

City, Kansas) and associate editor of the Journal of Atrial 

Fibrillation approached Transoma about using the device 

in the study. 

The Sleuth AT is subcutaneous and sits under the pectoral 

region and is about the size of a 50 cent piece. 

The Personal Diagnostic Manager (PDM) component of 

Sleuth is a hand-held, multipurpose device that automatically 

retrieves and stores relevant ECG data from the 

implanted cardiac monitor (ICM), securely relays the information 

to the base station and then to the monitoring center. 

The PDM is also used by the physician to program the 

implanted cardiac monitor and even to view non-transmitted 

ECGs immediately after capture. Patients who experience 

symptoms, such as lightheadedness, can press a button 

on the PDM which tells the system to store the patient’s 

ECG strip during the time of the symptom. 

The system automatically captures and stores the ECG 

strip when the patient’s heart rate is above or below physician-programmed 

limits. 

It can be programmed to capture a 20-second ECG strip 

every 7.5 minutes, or every 15 minutes, or every four hours, 

according to the company. So in essence, if the physician 

wanted to monitor a patient for complex arrhythmias, 

including AF, he or she would get a monthly report, looking 

at the patient for 20 seconds as often as every 7.5 minutes. 

Transoma said the system includes an implantable loop 

recorder, a personal diagnostic manager, a base station and 

a 24/7 monitoring center operated by Medicomp (Chantilly, 

Virginia) and staffed by certified cardiac technicians who 

classify and notify physicians of the presence of a wide variety 

of cardiac arrhythmias such as ventricular tachycardia, 

bradycardia, supraventricular tachycardia and AF. 

If the cardiac technician observes a particularly concerning 

arrhythmia, the patient’s physician will be contacted 

immediately, the company said. 

“Where our device is different from others is that we 

have continuous monitoring,” Kim said. “The device is also 

truly wireless unlike other offerings.” 

Competitors sharing this market include, Medtronic’s 

(Minneapolis) Reveal XT and its Reveal DX insertable cardiac 

monitors are placed just under the skin of the chest 

area in a short outpatient procedure, and are also designed 

to capture an ECG during the actual episode. Another such 

device is St. Jude Medical’s (St. Paul, Minnesota), Confirm 

ICM – a device is the size of a computer thumb drive. 

Transoma maintains that its wireless capabilities help 

distinguish it from the competition and said that this new 

study will change and quite possibly redefine the ICM market. 

“Being a part of COMPLIANCE is huge for us,” Kim told 

MDD. “There’s so much interest in this form of monitoring 

and we’re grateful that Dr. Lakkiredd has included us.” 






Gold-wrapped nanotubes may be 

formula for better imaging 



A thin layer of gold wrapped around nanotubes may be 

the secret formula for a better contrast imaging agent – one 

that enhances absorption of laser radiation and simultaneously 

reduces toxicity. This new imaging agent being 

developed at the University of Arkansas and 

University of Arkansas for Medical Sciences (UAMS; 

Little Rock) is capable of molecular mapping of lymphatic 

endothelial cells and detecting cancer metastasis in sentinel 

lymph nodes. 

“The absorption of near-infrared (NIR) radiation is an 

important issue for non-invasive photoacoustic [laserinduced 

sound wave] detection and photothermal [laserinduced 

heat] treatment,” Jin-Woo Kim, associate professor 

in the department of biological and agricultural engineering 

at the University of Arkansas, told Medical Device Daily. 

“Indeed, because most biotissues are relatively transparent 

to NIR radiation, targeting of tumor cells with strongly NIR 

absorbing nanoparticles could allow both highly sensitive 

diagnosis and targeted killing of tumors noninvasively in a 

whole body at the laser energy, which is safe for surrounding 

healthy tissue.” 

Many researchers have avoided using nanotubes as 

part of imaging agents because of the potential toxicity 

that comes with these little hollow particles. But Kim and 

his collaborator, Vladimir Zharov, professor in the Winthrop 

P. Rockefeller Cancer Institute at UAMS, found that gold 

solved the problem and even enhanced the effectiveness of 

radiation. The gold nanotubes required low laser-energy 

levels for detection and low concentrations were required 

for effective diagnostic and therapeutic applications. 

Their work – which targeted imaging lymphatic vessels 

in mice – is reported in the current issue of Nature 

Nanotechnology. 

In a previous study, Kim and Zharov demonstrated that 

carbon nanotubes held a great promise as NIR contrast 

agents for photoacoustic detection and photothermal 

killing of individual bacteria in the blood system. However, 

they suffer from relatively poor NIR absorption, and questions 

abound about their toxicity. 

“We addressed this problem by depositing a thin layer 

of gold around the carbon nanotubes. The gold layer 

enhanced absorption of laser radiation and reduced toxicity,” 

Kim said. “In vitro tests showed only minimal toxicity 

associated with the golden carbon nanotubes (GNTs). 

Furthermore the synthesis process is very robust and simple, 

inexpensive and environmentally friendly green one. 

The reaction of the carbon nanotubes and gold chloride 

occurs in water and happens at ambient temperature. No 

other chemicals or special conditions, such as heating, are 

135 

required.” 

The team’s GNTs synthesized in this study are shorter 

than carbon nanotubes used in the previous study, but they 

absorb NIR radiation at least twice as effectively. 

“Two-order higher concentrations of carbon nanotubes 

will be required to have the same photothermal responsiveness 

as GNTs,” Kim said. “Taking into account the issue 

of toxicity – i.e., as long as the controversy exists and until 

full-scale studies prove one way or the other, we should not 

assume the particles to be safe. The amount of nanoparticles 

applied for biomedical applications, such as in vivo 

clinical diagnosis in human, becomes more important. The 

less, the better. Furthermore, gold is chemically inert, so it 

is highly possible to rule out potential toxicity.” 

Kim said that recently gold-based nanoparticles, in particular 

gold nanoshells AuroLase, made by Nanospectra 

Biosciences (Houston) and colloidal gold nanospheres conjugated 

with tumor necrosis factor alpha, made by 

Cytimmune Sciences (Rockville, Maryland), have been 

approved for pilot clinical trials for cancer treatments. That 

led his team to assume a gold coating could potentially 

improve the biocompatibility of carbon nanotubes. 

Some of the unique features of GNTs compared with 

existing nanoparticles include: 

• One of the highest near-infrared absorption at a 

minuscule diameter (up to 3 nm-5 nm). 

• Absorption can be adjusted in NIR window of transparency 

of biotissue to provide deeper laser penetration 

and advanced diagnosis. 

• They provide multimodal function as triple contrast 

agents for photoacoustic and photothermal detection and 

photothermal therapy. 

“With the GNT with such unique property, we successfully 

demonstrated in vivo molecular mapping of lymphatic 

vessels, and targeted detection and purging of metastasis 

in lymph nodes, which is an important site of tumor 

spreading,” Kim said. “This new nanomaterial could be an 

effective alternative to existing nanoparticles and fluorescent 

labels for non-invasive targeted imaging of molecular 

structures in vivo.” 

In addition to diagnosing cancer, Kim said the GNTs 

could also be used therapeutically for cancer as well as bacterial 

and viral infections, such as antibiotic-resistant 

staphylococcus aureus. 

“For example, in this study, we demonstrated molecular 

detection of lymphatic endothelial cells and highly precise 

targeted destruction of lymphatic wall in vivo,” he said. 

“This holds promise for mapping and destruction of intraor 

peri-tumor lymph vessels that provide initial dissemination 

of detached tumor cells to metastatic sites. Another 

example is to apply our developed technique for the detection 

and purging of cancer metastasis in so-called sentinel 

lymph nodes that is important for early cancer staging with 

potential to improve cancer treatment and reducing 

patient’s morbidity through replacement of conventional 



136 


surgical approach with noninvasive laser ablation.” 

Kim and Zharov are continuing to explore the optical 

properties of this nanoparticle with different dimensions 

and to use double- and multi-walled carbon nanotubes as 

core and different bioconjugation for targeting normal and 

abnormal cells. 

“Specifically, we are currently investigating the potential 

of golden carbon nanotubes for molecular detection 

and eradication of metastasis in the sentinel lymph nodes 

and real-time tracking of golden carbon nanotubes in ear 

and skin animal vasculatures, as well as an toxicity study of 

golden carbon nanotubes in vivo,” he said. 

Although the team’s preliminary toxicity results 

reveal minimal toxicity, comprehensive toxicity evaluations 

are required before any human trials could be initiated. 

“We expect the completion of toxicity evaluation in a 

few years,” he said. 

Their research was supported by the National 

Institutes of Health, the National Science Foundation and 

the University of Arkansas System’s Division of Agriculture 

and the Arkansas Biosciences Institute. 

(This story originally appeared in the Sept. 2, 2009 edition 





Nanotech experts take aim at 

the real cancer killer: metastases 

137 



Although primary-site cancer can kill people, it’s the 

spread of cancer – metastases – that is most directly 

responsible for the majority of cancer-related deaths. 

That’s why a team of nanotechnology experts led by 

University of Arkansas for Medical Sciences (UAMS; 

Little Rock, Arkansas) researchers have aimed a cocktail of 

nanoparticles at tumor cells circulating in the blood. 

“Most cancer deaths, up to 90%, are related to metastasized 

tumor cells that spread from the primary tumor to 

distant organs. Our goal is to provide early diagnosis of 

metastasis and if successful, prevent, or at least inhibit, this 

process; and those circulating tumor cells are our target,” 

Vladimir Zharov, director of the Phillips Classic Laser and 

Nanomedicine Laboratory at UAMS, told Medical Device 


Zharov’s team has come up with a relatively straightforward 

approach to collect, detect and kill those circulating 

cells: inject a cocktail of magnetic and gold nanoparticles 

into the bloodstream to target circulating tumor cells. 

Then a magnet is attached to the skin above peripheral 

blood vessels to capture these cells labeled by magnetic 

nanoparticles and a laser then detects of captured cells 

labeled by gold nanoparticles. The application of two types 

of nanoparticles with strong magnetic and absorption 

properties allows for the combination of effective magnetic 

enrichment of the rare circulating tumor cells with highly 

sensitive and specific laser-based photoacoustic diagnosis 

of the accumulated cells. In this application magnetic 

nanoparticles served as a dual magnetic and photoacoustic 

contrast agent using the intrinsic near-infrared absorption 

of an iron core. “These nanoparticles have biological coatings 

to target tumor cells with specific markers only, and 

avoid nonspecific binding to normal blood cells, which 

don’t express these markers” he said. “This process of targeting 

cells in the bloodstream takes a few minutes after 

injection. Then we attach a magnet to the skin above the 

vessels and wait, sometimes for 30 minutes to one hour, 

and then use a near-infrared laser to irradiate vessels near 

the magnet.” 

In mice, the approach works. Zharov and colleagues 

report in Nature Nanotechnology how they have functionalized 

magnetic nanoparticles to target a marker commonly 

found in breast cancer cells. Gold-plated carbon nanotubes 

are also used to improve detection sensitivity and 

specificity. They are conjugated with folic acid and used as 

a second contrast agent for photoacoustic detection and 

photothermal therapy. As a result, the team integrated in 

vivo multiplex targeting, magnetic enrichment, signal 

amplification, multicolor recognition and a laser killing circulating 

tumor cells after their concentration from a large 

volume of blood in the vessels of tumor-bearing mice. 

In a second, related article in Cancer Research, Zharov’s 

team demonstrated that periodic laser irradiation of blood 

vessels decreases the level of circulating metastatic tumor 

cells more than 10 times and eventually led to an interruption 

of metastasis development in distant organs. 

“It’s a similar procedure, but we use naturally 

expressed melanin nanoparticles,” he said. “We don’t need 

to inject synthetic nanoparticles for this process.” 

The team developed a method for in vivo photoacoustic 

blood cancer testing with a high-pulse-repetitionrate 

diode laser that was applied to melanoma. It uses the 

overexpression of melanin nanoclusters as intrinsic, spectrally-specific 

cancer markers and signal amplifiers, providing 

high photoacoustic contrast of melanoma cells compared 

with a blood background. 

In tumor bearing mice and melanoma-spiked human 

blood samples, they showed a sensitivity level of 1 CTC/mL 

with the potential to improve this sensitivity 1,000-fold in 

humans in vivo, which is impossible with existing assays. 

The technique can be used not only for early diagnosis 

of cancer, but also for laser blood purging of the cancer 

cells, using noninvasive or hemodialysis-like schematics to 

prevent metastasis. 

Although the group used a melanoma model, “We think 

our technology is relatively universal because we can inject 

synthetic nanoparticles specific to each cancer. We just 

need to develop the nanoparticles with special biological 

conjugates,” Zharov said. 

“It’s our goal to provide early detection of tumor cells 

before metastases develops,” he said. “Once detected, the 

second stage is to kill them immediately. The same laser we 

used for diagnosis can be used for killing the same tumor 

cells by increasing a little laser energy.” This leads to heating 

of strongly light absorbing nanoparticles accompanied 

by microbubble formation around overheated nanoparticle 

clusters on cell membranes that eventually provides cell 

ablation. The group worked with a customized laser it 

developed and is now searching for a commercial laser 

with similar parameters for use in upcoming clinical trials. 

Zharov said he has obtained the necessary FDA 

approvals for pilot clinical study and testing in humans is 

expected to begin within the next two years. 

(This story originally appeared in the Nov.25, 2009 edition 




138 

Researchers find HIFU suitable 

for brain surgery procedures 

By OMAR FORD 


A team of researchers at MR-Center of the University 

Children’s Hospital (Zurich, Switzerland) are one step 

closer to providing noninvasive procedures in nearly every 

part of the body using MRI guided ultrasound. 

They recently completed a pilot study using transcranial 

MR-guided high intensity focused ultrasound (HIFU) to 

treat 10 patients with neuropathic pain (Medical Device 

Daily, July 15, 2009). 

The origin of chronic pain in these patients included 

post amputation phantom limb syndrome, nerve injury, 

stroke, trigeminal neuralgia and post herpetic neuralgia 

from shingles. 

The researchers implemented and optimized a prototype 

system for transcranial magnetic resonance-guided 

high-intensity focused ultrasound (HIFU) for neurosurgical 

interventions. The HIFU system ExAblate 4000, developed 

by InSightec (Dallas), has been combined with a 3 Tesla 

high field GE MR-scanner. The two systems together provide 

a platform for image-guided, non-invasive interventions. 

These findings are set to be published in a forthcoming 

issue of Annals of Neurology and have the potential to turn 

the way the medical community thinks about HIFU on its 

ear, say researchers of the study. 

Neal Kassell, MD, a neurosurgeon at the University of 

Virginia (Charlottesville), and chairman of the Focused 

Ultrasound Surgery Foundation, which helped fund the 

study, said that the benefits of this procedure were numerous. 

“First of all it’s totally non invasive and you’re able to 

treat the patient in real time. Plus the effect of the procedure 

is known immediately,” Kassell told Medical Device 


“It’s proof that through the intact skin and skull you can 

make lesions in an awake person’s brain,” he said. “These 

results are huge milestone in the field of focused ultrasound. 

The fact that you can treat the brain with this procedure 

means you can treat other things. I think in the next 

few years we’ll see the liver, pancreas and prostate treated 

this way.” 

The study was partially funded by the Focused 

Ultrasound Surgery Foundation. The Foundation funds 

translational and clinical research into new therapeutic 

applications of MR-guided focused ultrasound (MRgFUS). 

The preliminary results in these patients are consistent 

with conventional therapy – radio frequency ablation - 

which is an invasive procedure and involves making an 


incision in the scalp, drilling a hole in the skull, inserting an 

electrode through normal brain tissue into the thalamus, 

and using radio frequency to create the lesion. 

Researchers say the procedure is painless and quick. 

Instead of going in for surgery, the patient is basically 

going in for an MRI. The patient is sent through an MRI scanner 

similar to a regular diagnostic MRI scanner only this 

scanner has a special ultrasound system integrated into it 

which can non-invasively ablate tissue inside the brain. It 

essentially is an outpatient procedure and no anesthesia is 

used at all. 

“This research demonstrates that transcranial MR-guided 

focused ultrasound can be used non-invasively to produce 

small thermal ablations with extreme precision and 

accuracy deep in the brain,” he said. 

The study proved that researchers can perform successful 

operations without opening the cranium or physically 

penetrating the brain with medical tools, something 

that appeared to be unimaginable only a few years ago. 

According to Kassell, the key advantage of focused it 

safer than conventional surgery because it avoids the associated 

risks of complications such as infection, hemorrhage, 

and collateral damage to normal brain structures. 

For years, HIFU has been used for the treatment of uterine 

fibroids and tumors of the prostate gland. However, its 

application to the brain through the intact skull for noninvasive 

neurosurgery was not possible until recently, 

because of complications. 

The plan now is for other research sites are now 

expected to initiate clinical studies using Transcranial MRguided 

focused ultrasound for brain disorders within the 

next year, including studies for Parkinson’s disease, essential 

tremor, and brain tumors. 

“I posit that in 10 years from now that people will either 

be treated by this procedure or they’ll know someone who 

has been treated by this procedure,” Kassell said. “But for 

now we’re very very, very much on the ground floor.” 






New imaging analysis provides 

new ‘map’ for tumor survival 

By ROB KIMBALL 


One of the constant barriers that physicians, and their 

patients, seem to encounter is the battle against time. In the 

case of tumor treatments and diagnosis, researchers have 

published a study that could save time to recovery if a 

treatment isn’t working for a patient — via a new way of 

observing a standard MRI. 

As early as one week after beginning treatment for 

brain tumors, a new imaging analysis method was able to 

predict which patients would live longer, researchers from 

the University of Michigan Comprehensive Cancer 

Center (Ann Arbor) have found. 

The method uses a standard magnetic resonance imaging 

(MRI) protocol to monitor changes over time in tumor 

blood volume within individual voxels of the image, rather 

than a composite view of average change within the tumor. 

This parametric response map (PRM) allowed researchers 

to see specific areas in which tumor blood volume 

increased or decreased, that may have canceled each other 

out when looking at the changes as an average. 

Results of the study appear in the advance online edition 

of Nature Medicine. 

Craig Galban, PhD, assistant professor of radiology at 

the U-M Medical School and the study author, told Medical 

Device Daily that this could be a “huge paradigm shift” if 

clinicians go in this new direction. Galban describes the 

potential for this imaging analysis as “adaptive therapy.” 

The researchers looked at 44 people with high-grade 

glioma, a type of brain tumor, who were treated with 

chemotherapy and radiation. Each participant underwent 

MRIs before treatment, and one week and three weeks after 

starting treatment. The researchers then looked at the relative 

cerebral blood volume and the relative cerebral blood 

flow of the tumor to analyze voxel-wise changes among 

the serial scans. 

Looking at standard comparisons using averages, the 

scans indicated no change one week and three weeks into 

treatment. But, using the parametric response map 

approach, the researchers were able to show changes in 

the tumor’s blood volume and blood flow after one week 

that corresponded to the patient’s overall survival. 

“Right now, physicians have to wait until the treatment 

is over to determine if it was effective. We are proposing 

that we can determine right away if the treatment is effective. 

If it is not working, then we can tailor the therapy rapidly 

to the individual. We are trying to personalize the care 

and get this valuable and accurate information to the clinician 

so that they can make a decision on the proper course 

of treatment for the patient,” Galban told MDD. 

High-grade gliomas have a high-mortality rate, with 

139 

people surviving only an average of 12 months after diagnosis. 

Typically, patients receive six to seven weeks of 

treatment, followed by a traditional MRI scan six weeks 

after completing therapy to determine if the tumor shrank. 

If the cancer did not respond to the treatment, a new 

approach may be tried. 

A voxel is a volume element, representing a value on a 

regular grid in 3-D space, as compared to a pixel which is 2- 

D. As with pixels, voxels themselves typically do not contain 

their position in space (their coordinates) — but rather, 

it is inferred based on their position relative to other voxels 

(i.e., their position in the data structure that makes up a 

single volume image). 

Galban explained the differences in standard imaging 

analysis compared to PRM for MDD. “It’s really looking at 

voxel-wide changes,” he said. “PRM is measuring the 

changes in blood volume in these individual voxels. The 

standard way to look at the functional data [such as an MRI 

on a tumor] is to take all the information and gather it into 

a mean, or average. We are proposing not just to look at the 

statistical average of all the voxels and blood volume, but 

to examine them discreetly and individually, and determine 

spatially how much of the tumor did respond to treatment. 

These are highly heterogeneous tumors. Some of the tumor 

might have responded well to the treatment, but another 

part of the tumor may not. So that’s how BPM differs — it is 

really looking at changes in the blood volume in the individual 

voxels. We’re interested in how much of that tumor 

volume changes. “ 

The researchers believe this approach might also be 

useful with other imaging techniques such as PET and CT 

scans. 





140 

Nanomaterial enables microchip 

to diagnose cancer in under 1 hour 



Researchers at the University of Toronto (UT) have 

used nanomaterials on a microchip to create a diagnostic 

test that’s sensitive enough to identify the type and severity 

of a person’s cancer in under an hour. The technology 

also is being developed for use to diagnose infectious diseases 

with the same speed. 

“Today, it takes a room filled with computers to evaluate 

a clinically relevant sample of cancer biomarkers and 

the results aren’t quickly available,” Shana Kelley, lead 

investigator on the project and a co-author of a study 

appearing in Nature Nanotechnology, told Medical Device 

Daily. “Our team was able to measure biomolecules on an 

electronic chip the size of your fingertip and analyze the 

sample within half an hour. The instrumentation required 

for this analysis can be contained within a unit the size of a 

BlackBerry.” 

And the group already has plans to spin out a company 

to develop the new test with an eye on getting to market 

within five years. 

“We designed this platform to be highly sensitive and 

practical because we wanted it to be something cheap 

enough to manufacture and make it into clinical use,” Kelley 

said. “It’s very straightforward microfabrication of the chip. 

The chips are outsourced, but what’s special about it is that 

we grow nanostructures on the chips. By introducing 

nanostructured elements on the chip, we improve sensitivity 

of biomolecular detection by many orders of magnitude. 

That’s pretty difficult to do without PCR. The platform is 

also quite versatile.” 

Kelley’s team originally found that conventional, flat 

metal electrical sensors were inadequate to sense cancer’s 

particular biomarkers, which is why they designed and fabricated 

a chip and then decorated it with nanometer-sized 

wires and molecular bait. 

In addition to applications in cancer, the chip would 

have strong use in diagnosing infectious diseases. 

“A very important application is in using this platform 

for infectious disease diagnosis,” she said. “One of the 

advantages is that it’s very fast. We can do our detection 

runs in minutes and see the appearance of robust signals. 

For infectious disease, it’s time sensitive. For cancer diagnosis, 

the next day is usually good enough. But with infectious 

disease you want to know that patients’ status immediately, 

especially in a hospital setting. That’s what we’re 

working very hard on now - to show we can interface our 

chips with a way to break up bacteria and get the same kind 

of sensitivity to discriminate different pathogens.” 

Regarding its original use for cancer, the microchip 

senses the signature biomarkers that indicate the presence 


of cancer at the cellular level, even though these biomolecules, 

which are genes that indicate aggressive or benign 

forms of the disease and differentiate subtypes of the cancer, 

are typically present only at very low levels in biological 

samples. 

Results are available in about 30 minutes, compared 

with existing tests which yield results in a matter of days. 

“We demonstrated that we can use this microchip to 

look at RNA samples isolated from cell lines or patient biopsy 

samples for prostate cancer,” she said. “We have very 

high sensitivity and good specificity when challenging the 

platform with heterogeneous samples.” 

The actual surface structure of the sensor element is 

nanoscale while the features on the chip are microns in 

scale. 

“The more fine the nanostructure the more sensitive 

the device becomes,” Kelley said. “The nanostructures on 

the chip boost sensitivity.” 

So far her team has worked on small numbers of samples 

and is now scaling up to work with much larger batches. 

“We’re in the process of figuring out how to get it out of 

university lab and into an entity that can refine it,” she said. 

“Were’ probably going to spin out a company, but the economic 

situation isn’t great now. If it was a few years ago it 

would be a lot easier to drum up the money. We think it can 

be in the clinic within five years. But it’ll likely be pretty 

easy for us to beat that estimate.” 

Kelley’s team includes UT engineering professor Ted 

Sargent, who is also UT’s Canada Research Chair in 

Nanotechnology, along with an interdisciplinary team from 

Princess Margaret Hospital (Toronto) and Queen’s 

University (Kingston, Ontario). 

“Uniting DNA – the molecule of life – with speedy, 

miniaturized electronic chips is an example of cross-disciplinary 

convergence,” said Sargent. “By working with outstanding 

researchers in nanomaterials, pharmaceutical sciences 

and electrical engineering, we were able to demonstrate 

that controlled integration of nanomaterials provides 

a major advantage in disease detection and analysis.” 






Pilot study set for Surinate 

in treating urinary retention 

By DON LONG 


A blocked urinary tract – not a big problem, right 

Of course it is, one that means frequent insertions and 

removals of catheter devices – usually the basic Foley 

catheter – and offering highly opportunistic possibilities 

for infections, those infections being a major source of 

nosocomial infections. 

In both cases, the insertion/removal process and frequent 

infections, the consequences add up to huge healthcare 

costs and, for the patient, embarrassment and inconvenience 

to those who suffer from this problem. 

Addressing both issues is early-stage firm Urovalve, 

located in the Enterprise Development Center at New 

Jersey Institute of Technology (Newark, New Jersey). The 

company is a developer of remote-controlled fluid valves 

used for managing the problems of urinary retention and 

incontinence. 

Urovalve has just reported launch of a pilot study of its 

Surinate Bladder Management System, for controlling the 

urinary flow in men who suffer from either acute or chronic 

urinary retention due to obstruction of the urethra. 

President/CEO Harvey Homan, PhD, told Medical Device 

Daily that the company hopes to complete the pilot study, 

of 15 men, by the end of January and then launch a pivotal 

study, of at least 50 men, which it hopes to complete in six 

months. 

The company has received advice from a consultant at 

Quintiles (Research Triangle Park, North Carolina) for filing 

of a 510(k) which would allow, in the best case, FDA 

approval and commercialization by 2010. 

As an alternative to the frequent insertions and 

removals of urinary catheter devices – sometimes multiple 

times a day – the Surinate system provides for a single 

insertion in a 28-day cycle, leaving no tubes or other materials 

outside the body, such as a urine-collection bag, and 

enabling the individual to void urine from his bladder by 

using a magnetized valve control. 

Besides greatly reducing the chance of urinary infection, 

the valve system provides for its unobtrusive operation, 

providing lifestyle normalcy. 

The ability to avoid infection, especially of the hospitalrelated 

type, is a huge money-saver, putting Urovalve on an 

important savings wave. 

“We think we’re in front of the wave,” Homan said. “The 

issue of the health problems associated with catheters is 

more serious than has been acknowledged.” 

The system targets both acute and chronic urinary 

retention, the acute condition often related to prostate 

problems and treatments, the chronic condition frequently 

related to spinal cord injury and other conditions causing 

141 

paralysis. 

Homan said that the exact number of patients that 

might use the system is difficult to calculate exactly. But 

with millions of men with prostate problems and many 

thousands with spinal cord injuries, the population that 

could use the Surinate is potentially in the “hundreds of 

thousands, if not in the millions . . . We’re going to have to 

understand over time exactly what that number is . . . .” 

When the Surinate is inserted, one end is placed in the 

bladder and expands into a cage, with urine than flowing 

down through sphincters above and below the prostate 

toward the control valve. 

The valve is operated by a switching magnet. The 

patient simply moves a thumb-sized magnet close to the 

scrotum in order to open the valve to permit urine to flow 

through the urethra and then moves the magnet way to 

close the valve and stop the flow. 

The system is inserted in the urologist’s office. Because 

of a natural buildup of dead cells and other deposits, it 

must be removed after 28 days and, in the case of chronic 

obstruction, a new system is then inserted. 

The system for inserting the Surinate is withdrawn, 

leaving nothing outside the body, a key feature of the system 

helping to avoid infection, Homan noted. 

The pilot study is being conducted at four sites: VA 

Boston Healthcare System; VA New Jersey Healthcare 

System (East Orange); Vanderbilt University Medical Center, 

Department of Urologic Surgery (Nashville, Tennessee); and 

the Virginia Urology Center (Richmond). 

Eugene Kramolowsky, MD, of the Virginia Urology 

Center and one of the study’s principal investigators, said 

the Surinate “represents a significant change from conventional 

catheters, where there is no valve and the patient 

voids basically into a collection bag, which is very inconvenient 

and somewhat unsightly. Surinate may represent a 

significant advancement for men with a urinary retention 

condition.” 

The company did not do initial studies of the system 

with animals. Because it needed to test the architecture of 

the design specifically in human anatomy, it performed its 

first feasibility study in five spinal cord-injured men. 

Homan said the system was initially developed by 

Philip Davis, who had suffered a broken back and thus 

experienced the many difficulties of the usual handling of 

urinary obstruction. 

He referred to studies indicating that 65% of those having 

urinary catheters get an infection at least once a year, 

and that the common difficulties with such catheters result 

in $2.5 billion dollars in yearly healthcare costs. 

Exactly how much the system might reduce such costs, 

Homan acknowledged, “will require a fairly significant 

study to be able to accrue enough patients to demonstrate” 

such savings. 

He said that the company may pursue the opportunity 

to expand the valve system to its use in women and then to 



142 


other applications, but that initial focus on the firm’s fivemember 

team is development of the system for men before 

pursuing other opportunities. 

Homan reported that the company thus far has raised 

$3.7 million dollars from private investors and other 

sources, most recently receiving $400,000 from the New 

Jersey Commission of Science and Technology, and a 

$740,000 SBIR grant from the National Institutes of Health. 

And given the potential clinical and money-saving benefits 

of the Surinate, he expressed confidence that the company 

is likely to receive additional NIH grant funding “in the 

near term.” 






US Endoscopy launches spongy 

device for ERCP procedures 



It’s not always about bells and whistles. 

Sometimes the most useful medical devices are simple 

products developed in response to clinicians’ needs. Such 

is the case with the Boost, a head-stabilizing device from 

US Endoscopy (Mentor, Ohio) designed to hold a patient’s 

head still during endoscopic retrograde cholangiopancreatography 

(ERCP). 

It’s not a high-tech device like some of the other tools 

used by gastroenterologists, but US Endoscopy says it has 

never found a bigger unmet need than the one the spongy 

Boost fills. 

“Nothing has been built for this purpose,” said Tamara 

Struk, a senior product manager at US Endoscopy. 

Struk told Medical Device Daily that prior to the Boost 

becoming available in July, clinicians used rolled up towels, 

sheets, pillows, or some combination of those items to stabilize 

the patient’s head during an ERCP – a multiple-hour 

procedure that uses endoscopes that slide into the 

patient’s body to determine problems in the liver, gallbladder, 

bile ducts or pancreas. She called these methods of stabilizing 

the patient’s head “suboptimal,” because the “stability 

of the head” during an ERCP is “extremely important.” 

The company estimates that at least 500,000 ERCPs are 

performed each year. During the procedure, patients lay 

face down or on their sides. The procedure can discover 

gallstones, internal leaks or cancer, among other things, US 

Endoscopy said. 

The Boost is made of polyether polyurethane, is 

designed for the “vast majority” of head sizes and should 

hold its shape for four hours, according to the company. 

The hole keeps there from being constant pressure on the 

ear. One of the challenges in designing the device was creating 

a cushion that could support patients’ heads for the 

length of a procedure. 

US Endoscopy officially launched the Boost in July, following 

a limited release of the product to get customer 

feedback. “Our feedback has been positive, particularly 

from nurses and anesthesiologists . . . the people who typically 

monitor the patients [during the ERCP] are the nurse 

or anesthesiologist,” Struk said. 

The biggest challenge US Endoscopy encountered 

while developing the Boost, Struk said, was coming up with 

a product that would fit most head sizes. 

“Obviously there are a variety of sizes of people in the 

hospital and a variety of sizes of heads,” Struk said. 

Ultimately what the company came up with, she said, is 

what they consider a “one size fits most” device. 

Struk said the company spent about a year and a half 

developing the Boost. 

143 

“US Endoscopy really is a company that’s founded on 

looking at different customer needs out in the market place 

and delivering on those needs . . . we really like to get ideas 

directly from physicians, nurses and technicians and be 

able to meet those needs,” Struk told MDD. 

US Endoscopy, a private company, also makes other 

accessories for the GI endoscopy market, including 

retrieval devices. 





144 

Compliance, PEEP are benefits 

of Provent sleep therapy device 

BY DON LONG 


Every “gold standard” therapy has its challengers, in 

the form of alternative treatments promising safer/cheaper/more 

effective results. And the primary therapy for 

sleep-disordered breathing, known as CPAP – though generally 

acknowledged even by its challengers to be highly 

effective, if not entirely “gold standard” -worthy – seems to 

have more than the usual contenders claiming patient 

attention. 

CPAP (for continuous positive airway pressure) attracts 

a whole range of competitors because of its major drawback: 

It’s neither aesthetically nor psychologically pleasant 

to wear a mask over your face, to force air in and out, while 

sleeping. So while CPAP is an important part of sleep clinic 

work and decreases the symptoms of sleep apnea and 

other sleep-disordered problems, it’s estimated that it garners 

only about 50% compliance in outside-the-clinic use 

by those it could help. A therapy frequently not used 

attracts competition – from multiple methods promising to 

reduce snoring (both drugs and devices), to surgery and 

surgical implants for the throat and mouth, to a range of 

oral appliances. 

Enter Ventus Medical (Belmont, California) with its 

Provent Sleep Apnea Therapy, and its CEO, John 

McCutcheon, who told Medical Device Daily that he represents 

“the poster child” for a variety of sleep therapies, 

since he’s tried several of them and is one of those noncompliant 

with CPAP. He says that he recently joined the 

company only after he had used Provent for several weeks 

and found that it significantly improved his sleep, thus 

becoming an experienced advocate (but saying he’s not 

quite yet infomercial-ready). 

Highlighted by three poster sessions at last week’s 

SLEEP 2009, the 23rd annual meeting of the Associated 

Professional Sleep Societies (Westchester, Illinois) in Seattle, 

Provent is deceptively simple: essentially a valve, a pair of 

them taped over the nostrils with a hypoallergenic adhesive 

while sleeping. The valves – combining medical-grade 

silicone film and polypropylene materials – facilitate the 

in/out movement of air and have been shown to improve 

the breathing during sleep of many patients and offers – 

perhaps it’s most important benefit – simplicity of use and 

thus greater compliance. 

Disposable after each night’s use, the valve devices are 

offered 30 to a box. McCutcheon says a price point has not 

been set yet, but likely will be comparable to CPAP and significantly 

less than any surgical strategies. 

Various therapies for sleep apnea and disordered 


144 

breathing “have come and gone,” McCutcheon says, largely 

perhaps because of the range of disorders, a whole flock 

between simple snoring to apnea leading to heart disease, 

and a whole variety of causes. Provent was FDA-cleared last 

year, but has been used mostly at trial centers rather than 

being aggressively marketed. The reason, McCutcheon 

acknowledges, is that, like many 510(k)-cleared products, 

the company has to build confidence, and a payer foundation, 

by developing clinical evidence, with the posters at 

SLEEP 2009 being one such effort. One of the posters, 

described as a “physiologic mechanism of action” study, 

found that Provent produced sleep improvements in eight 

of 11 patients. Of the eight patients, five demonstrated a 

“complete response” and in three what was described as a 

“partial response.” 

David Rapoport, associate professor of medicine at 

New York University School of Medicine (New York) poster 

presenter, said that the findings “were associated with positive 

and prolonged intranasal pressure when the patient 

exhales.” He described this pressure as auto-positive endexpiratory 

pressure (autoPEEP) and said that it “keeps the 

airway open until the patient inhales, may increase the endexpiratory 

lung volume, and thus creates a pull on the trachea 

and upper airway. This is how Provent Therapy prevents 

apneic episodes and helps patients with sleep-disordered 

breathing.” 

In the eight responsive patients, “end-expiratory 

intranasal pressure” increased to a range between 11 cm and 

26 cm H2O during periods of complete success, whereas 

the nonresponders’ intranasal pressure ranged from 3 cm 

to 10 cm H2O, with lowest pressures at the time of failure of 

treatment. The researchers said that this indicates “that the 

increased pressure could have been the mechanism of 

action that keeps the airway open until the patient inhales.” 

Philip Westbrook, MD, emeritus professor of medicine 

at UCLA and chief medical officer for Ventus, said Provent 

offers a therapeutic alternative “that is discreet … disposable 

and comfortable to use throughout the night, regardless 

of a patient’s sleep position.” In a second poster, 

Westbrook and colleagues showed success rates and a significant 

change in Apnea-Hypopnea Index (AHI) in 58 

patients with sleep apnea using Provent via “expiratory 

resistive loading.” Provent Therapy reduced AHI from 

26.6±24.8 to 13.7±20.1, a 49% reduction. During the treatment 

night, 72% of subjects met either the AHI


145 

and that Provent thus “could be an early consideration for 

the treatment of OSA.” The third poster used a model that 

built in two key considerations: that Provent therapy doesn’t 

solve all sleep problems but also the significant patient 

resistance to CPAP and its non-use. 

Anne Abreu, director of reimbursement and business 

development at Ventus, and colleagues, in their presentation, 

showed that Provent may prevent a similar or greater 

number of abnormal breathing events as compared to 

CPAP. “This model demonstrates the importance of factoring 

in compliance rates when choosing a therapy for treating 

obstructive sleep apnea,” she said. 

McCutcheon told MDD that the company is looking for 

“broad commercialization” of Provent sometime next year 

and is still working to develop the exact valve structure, or 

structures – chiefly whether a single-valve architecture is 

best or if these need to be customized to individual problems 

and patients. Further out, he sees opportunities for 

broadening the applications, for instance, for COPD, but 

that the company for now will focus on the use for sleep 

apnea. And a key milestone could come next year with the 

successful pursuit of the CE mark. 





146 

Vesticon aims for ‘victory over 

vertigo’ with Epley Omniax 




Often times when a patient suffers from vestibular 

(inner ear) vertigo, a condition characterized by a specific 

type of dizziness, they are told they must learn to live with 

it because it is too difficult to determine which ear is causing 

the problem. 

Vesticon (Portland, Oregon) was founded in 2003 with 

the precise mission of achieving “victory over vertigo” and 

to get rid of the “learn to live with it” scenario that has 

become the standard prescription for these patients. In 

February the company launched its Epley Omniax system, a 

software-guided patient positioning system designed to 

help physicians and other care providers to accurately 

diagnose and effectively treat vestibular disorders including 

the most common type, known as benign paroxysmal 

positional vertigo (BPPV). 

Cathy Epley, president/CEO and founder of Vesticon, 

told Medical Device Daily that most of the training for the 

physicians who treat vertigo is in surgery, so most of the 

solutions that were available were surgical and they 

were incomplete solutions that were associated with a lot 

of side effects. 

Epley is the daughter of John Epley, MD, developer of 

the now-common “Epley Maneuver” for treating BPPV and 

the inventor of the Omniax. “When Dr. Epley in the 1980s 

came up with this new way of treating vertigo it was revolutionary 

– I don’t like to use words like that but he did 

change the existing theory on how to treat it and I think 

most people in the field would refer to it that way because 

he took away the need for surgery,” Epley said. She was in 

the cardiology field and wrote grants to develop the technology 

for her father. When the Epleys got the grants, she 

licensed his technology and started the company. 

The Omniax derives its name from the 360-degree 

multi-axial positioning it provides. According to Vesticon, 

the software-driven patient positioning system uses 

infrared goggles to assist caregivers in analyzing abnormal 

eye movement patterns that are associated with the shifting 

of loose particles in the inner-ear canals, which cause BPPV. 

The system is unique, the company says, because it gives 

physicians and therapists the ability to rotate patients to virtually 

any position, including a 360-degree flip. The science 

behind the system is derived from Dr. Epley’s “paradigmshifting 

work” in the vestibular field, Vesticon said. 

The Trinity Hearing & Balance Center (Trinity, Florida), 

an audiology center focused on treating dizziness and balance 

disorders, recently became one of just a handful of 

clinics to offer the technology since its commercial launch 

earlier this year. Trinity says it will have “much greater success 

identifying and treating the causes of dizziness” now 

that it has the Omniax. “Too often, the current standard of 

care comes up short and patients are told they must live 

with their condition,” said Kelly Hansen, MD, founder of 

Trinity Hearing & Balance Center, in a statement. “Now that 

we have the Omniax in place, the vast majority of those 

cases can be resolved.” 

Hansen, an audiologist of 18 years, says her main purpose 

for opening the practice was to provide a “state-ofthe-art” 

facility for diagnosing and treating dizziness and 

balance disorders. “Now I use the Omniax with every dizzy 

patient I treat,” Hansen said. “Here’s why: with one recent 

patient at another office where I sometimes fill in, I performed 

a table maneuver twice without success. The third 

time I suggested she come to my office where I could use 

the Omniax. After one treatment on the Omniax, she was 

completely fixed. Of course, she was thrilled and so was I.” 

According to Vesticon, the Omniax is the first device to 

offer precise nystagmus-based evaluation. “It provides 

caregivers unmatched ability to detect, differentiate, treat 

and manage balance and dizziness disorders,” the company 

said. Until now, BPPV diagnosis and treatment has 

involved a significant amount of educated guesswork and, 

if it is BPPV, manual maneuvers which tend to be both difficult 

to accomplish and imprecise, Vesticon said. When BPPV 

is diagnosed, the current standard of care is to perform the 

Epley Maneuver manually, the company noted. 

Epley said that balance disorders often involve loose 

particles (calcium stones or crystals) in more than one 

inner ear canal, or particles in a canal other than the posterior 

canal. Occasionally the problem is caused by some 

other issue, such as damage to the brain or a problem elsewhere 

in the ear, she said. 

The treatment for BPPV is usually moving the patient 

around to maneuver the loose particles out of the canals 

and into an area of the ear that will not be irritated, Epley 

said. She compared the process to getting a rabbit down 

into its hole. 

Epley said the emerging literature shows that the other 

canals are much more frequently where the problem is and 

she says the company is getting information on the 

Omniax to support that. To explain the importance of this 

new literature and why the system is so important to the 

diagnoses and treatment of this condition, Epley said it 

would be like a cardiologist treating heart attack patients 

by always only treating the left ventricle, instead of finding 

out what part of the heart actually needs treatment. “Maybe 

50% of the time you’d hit it and the other 50% you’d miss,” 




147 

she said. Or, for another way of looking at it, she said it 

would be like “kicking the pop machine.” 

“If you don’t monitor the eyes and understand eye patterns 

you’re kicking the pop machine and hoping that what 

you’re doing works,” Epley said. “It’s wasting the level of 

science in our field, which is an undeveloped area compared 

to something like cardiology.” With the Omniax system, 

a physician can now rule in or rule out various causes 

of vestibular vertigo and if it is determined that the cause is 

particles in the ear canal, the system provides a means to 

more easily and more effectively treat it, according to 

Vesticon. Research for the company’s products currently in 

development has been “generously” supported by the 

National Institutes of Health Small Business Innovation 

Program, Vesticon noted. The Omniax was the first of the 

company’s products to gain FDA approval. 

“Previously, much of our energy went into holding the 

patient in place and safely maneuvering the patient, which 

can be quite difficult when the individual is frail or heavy or 

experiencing nausea,” Hansen said. “With the Omniax, my 

patients are securely held in the exact position required 

and I can concentrate on watching the eye movements.” 





148 

FDA panel gives thumbs up to 

telescope for end-stage AMD 




A device that sounds a bit like something Inspector 

Gadget might use may soon be an available treatment 

option for people with end-stage age-related macular 

degeneration (AMD). 

An FDA advisory panel has recommended that the 

agency approve, with conditions, the premarket application 

for a tiny implantable telescope for end-stage AMD. 

The implantable telescope is the first device to be recommended 

by the FDA Ophthalmic Devices Advisory Panel for 

the disease. 

If the FDA follows the panel’s recommendation, 

VisionCare (Saratoga, California) may be able to market 

its device in the U.S. as early as the third quarter, or four to 

five months from now, President/CEO Allen Hill told 

Medical Device Daily. Although the agency usually follows 

the recommendations of an advisory panel, it is not 

required to do so. 

“We are pleased with the panel’s recommendation for 

approval and will work closely with FDA to address the 

approval conditions,” Hill said. “We look forward to providing 

the ophthalmic community a new treatment option to 

improve vision and quality of life for patients with untreatable, 

end-stage age-related macular degeneration.” 

End-stage AMD occurs when the macula in each eye is 

irreversibly degenerated and no longer provides detailed 

central vision required for common everyday activities 

such as recognizing people and facial expressions, or 

watching television. End-stage AMD is characterized by 

central scotomas, or blind spots, in both eyes that cause 

images in the central visual field to be unrecognizable or 

not visible at all. Hill said the implantable telescope is 

intended for patients with a visual acuity no better than 

20/80 and no worse than 20/800. 

Smaller than a pea, the telescope prosthetic device 

works like a fixed-focus telephoto lens in a camera, Hill 

said. A mono-vision device, it is implanted in one eye during 

an outpatient surgical procedure. He said it goes in the 

same place an intraocular lens would go. In the implanted 

eye, the device renders enlarged central vision images over 

a wide area of the retina to improve central vision, while the 

non-operated eye provides peripheral vision for mobility 

and orientation. 

The device is only 4 mm long and contains two wideangle 

microlenses, VisionCare noted. According to the 

company, the telescope, together with the cornea, can 

enlarge images up to three times, depending on the model 

used. The telephoto effect allows images in the central 

visual field to not be focused directly on the damaged macula, 

but over other healthy areas of the central and peripheral 

retina. This generally helps reduce the blind spot 

impairing vision in patients with AMD, hopefully improving 

their ability to recognize images that were either difficult 

or impossible to see, VisionCare said. 

After the procedure, the patient participates in a structured 

vision rehabilitation program to maximize their ability 

to perform daily activities, the company noted. 

VisionCare said the device allows patients to use natural 

eye movements to scan the environment and reading materials. 

According to the company, the telescope is virtually 

unnoticeable to others because it is completely implanted 

inside the eye and mostly covered by the iris, the colored 

portion of the eye. 

Hill told MDD there are no similar devices on the market 

or under investigation in the U.S. for end-stage AMD. He 

said VisionCare estimates that there are 50,000 to 60,000 

new cases of the disease each year. According to the 

National Eye Institute (Bethesda, Maryland) over 1.7 million 

Americans over age 50 suffer mild to profound vision loss 

from advanced AMD, which frequently culminates as endstage 

AMD (visual impairment due to untreatable advanced 

AMD). 

VisionCare is a privately-held company. The 

Implantable Miniature Telescope was invented by company 

founders, Yossi Gross and Isaac Lipshitz. 






A tiny silicone cup improves 

drug delivery for eye diseases 



Physicians and researchers have, for years, tried to get 

drugs into the eyes without a great deal of success. Much of 

it washes away and also gets absorbed into the body’s system. 

A tiny silicone cup sealed to the outer surface of the 

eye may provide a more effective method for the delivery 

of medicines for retinal and vitreous diseases such as cancer, 

macular degeneration and diabetic retinopathy. 

“We can get higher levels of drug in the eye with oneone-hundredth 

of the dose we’d get giving it systemically,” 

A. Linn Murphree, MD, director of the Retinoblastoma 

Program in The Vision Center at Childrens Hospital 

Los Angeles told Medical Device Daily. “So the patient 

would get much higher levels with lower exposures and 

virtually none getting into the systemic circulation.” 

Murphree’s work centers on treating retinoblastoma, a 

cancer of the retina that typically afflicts children, which 

calls for chemotherapy. Current treatment involves intravenous 

delivery. 

“We wanted any type of system to get chemotherapy 

into the eye in a better way,” Murphree said. So he and two 

other colleagues invented silicone cup, which differs from 

any sort of implant or insert currently available because it’s 

non-invasive and is attached temporarily with a bioadhesive 

glue. 

“Think about a coffee cup with a flattened rim,” 

Murphree said. “When you turn it upside down, it has a wide 

flange in contact with the eye and a bioadhesive is used on 

the lip.” 

The device can be reloaded with medication as needed. 

Known as the episcleral drug reservoir, it holds the 

potential to fundamentally change the delivery of medications 

for all eye diseases, according to a report delivered by 

Murphree last week at the Association for Research in 

Vision and Ophthalmology (ARVO) Summer Eye Research 

Conference on Ophthalmic Drug Delivery Systems in 

Bethesda, Maryland, where he explained that it works like 

an organ-specific transdermal skin patch. 

The cup isolates the medication targeted to the eye 

from being absorbed into the blood stream. It delivers medications 

to the interior of the eye over long periods of time 

up to months. 

Drops, periocular injections and intraocular injections 

are currently used to deliver medications to the eye but 

generally for short periods of time. 

This work is being backed by 3T Ophthalmics (Irvine, 

California), which holds the associated intellectual property 

license. 

The episcleral drug reservoir is inserted under the thin, 

filmy conjunctiva, or covering of the eyeball, to the sclera 

149 

the fibrous, protective outer layer of the eye. The cup 

administers the drug slowly by passive diffusion through 

the sclera, where it reaches the retina and vitreous. The 

device is so small the patient’s vision is unlikely to be 

affected. 

With preliminary testing complete, Murphree is currently 

developing a protocol for phase I/II clinical trials in 

humans, focused on retinoblastoma, to take place in 2010. 

Murphree’s first focus, retinoblastoma, requires relatively 

large doses to achieve a therapeutic concentration in 

the retina. A byproduct is that the chemo destroys the bone 

marrow and depresses the child’s immune system, often 

leading to secondary infections. All of this delays an effective 

administration of the drug and the ability to treat the 

cancer. 

“Our preliminary research shows that once the cup is 

fitted, the child should be able go home for several weeks. 

Because the drug is being administered directly into the 

eye and not systemically, chemotherapy dosage levels will 

be much lower and the debilitating side effects will be 

reduced,” Murphree said. 

He has tested the device in rabbits and observed they 

didn’t seem to feel discomfort when the cup was attached, 

nor did they experience side effects as they would from 

systemically administered drugs. 

The device is 8 mm to 10 mm with a reservoir that is 

about one-tenth of a millimeter. Liquids, tablets or gels 

could be loaded in the cup. 

“We’ve shown that we can get 30 to 40 times more drug 

this way than if you gave the same amount as an injection,” 

he said. “The difference is that you maintain the concentration 

radiant across the eye wall. Theoretically it could deliver 

drugs as large as Avastin and as small as antibiotics or 

steroids. It can stay on as long or as short a period as you 

want.” 





150 

Vital Therapies pushes ELAD 

past funding roadblocks 

By OMAR FORD 


Vital Therapies (San Diego) might be closer to bringing 

the Extracorporeal Liver Assist Device (ELAD) to market 

with its recent report of starting a third clinical phase trial 

for the device in September, but funding is still a concern 

for the small med-tech company, which has run out of cash 

twice in the past. 

“Is funding an issue, it’s always an issue with any small 

med-tech company,” Terry Winters Vital Therapies CEO told 

Medical Device Daily. “We’re not a Medtronic or a Pfizer. But 

I think we’ll overcome any funding issues because we’ve 

got some of the best investors in the medical device industry.” 

Since Winters joined the company back in 2003, nearly 

$40 million of funding has been raised. The latest round of 

funding occurred in 2007, when the company raised $28 

million. 

ELAD, which has garnered the support of investors 

such as Versant Ventures (Menlo Park, California), is more of 

a biological machine than a device, according to Winters. It 

peforms the liver’s functions outside of the body, creating 

essential proteins and cleaning toxins from the body – a 

key difference from other devices in the past. 

“In no sense of the word is this a filtration device,” he 

told MDD. 

The device is about the size of a refrigerator, but there 

are plans in the future to scale the machine down and get 

something more convenient for the clinical setting. 

If ELAD gains FDA clearance, then it could provide an 

alternative to liver transplants. It could also buy patients 

time until a donated organ could become available. 

Previous trials of the company have seen more than 120 

patients treated in the U.S., UK, China and Singapore. The 

company said that the study in China has shown improvement 

in survival without transplant in some patients. The 

company applied for marketing approval in China in 2007. 

Winters said if everything goes according to plan then 

the device could be on the market in the U.S. by the end of 

2011. 

“The best we could do to get this to market in the U.S. is 

in two years, and that’s if nothing goes wrong,” Winters 

said. 

But there have been difficulties in the past. The company 

is on its third iteration and previous iterations of the 

company have gone bankrupt twice. The first bankruptcy 

came during the first ELAD clinical trial and then the second 

came during the second phase of clinical trials. 

Vital Therapies isn’t the only company that has had difficulty 

in trying to bring a liver assisted device to market. In 

August of last year Arbios Systems (Waltham, 

Massachusetts) suspended its operations in a move that it 


said was a way to conserve cash while seeking financing to 

fund clinical trials for its Sepet Liver assist device. 

The device was intended as a bridge-to-transplant for 

patients waiting for a new liver – a list that is more than 

17,000 names long. Sepet is a sterile, disposable cartridge 

containing microporous hollow fibers with permeability 

characteristics. When a patient’s blood is passed through 

these fibers, blood plasma components of specific molecular 

weights are expressed through the micropores, thereby 

cleansing the blood of harmful impurities (hepatic failure 

toxins as well as various mediators of inflammation and 

inhibitors of liver regeneration). 

Sepet was designed for use with standard blood dialysis 

systems available in hospital intensive-care units. 

There are still some med-tech companies who haven’t 

quite run into the funding roadblocks that Vital Therapies 

and Arbios have. Both Hepalife (Boston) and HepaHope 

(Irvine, California) are also developing devices to assist in 

the liver’s functions. 

But despite problems and competition, Winters is still 

hopeful for the device which had its beginnings at Baylor 

College of Medicine in Houston back in 1991. 

Winters said it was a difficult plight that small med-tech 

companies found themselves in, when it came down to 

funding. 

“I don’t think any small company should be afraid to 

say that (funding is an issue),” he said. “But we’ve got the 

clinical data and results to back up [ELAD’s] effectiveness.” 






VisEn technology enables 

‘key’ scientific discovery 



VisEn Medical (Bedford, Massachusetts) is not surprised 

that its imaging technology has been used to generate 

“very useful data” enabling scientists to discover a new 

biologic pathway, according to Jeffrey Peterson, PhD, VP of 

Applied Biology at VisEn. But what Peterson is really 

pleased about is the fact that the research, published in the 

July 31 issue of Science, proves the imaging technology produces 

“more than just a pretty picture.” 

VisEn said researchers at the Massachusetts General 

Hospital’s (Boston) Center for Systems Biology have discovered 

a key disease-related biologic pathway using an integrated 

and “innovative” array of in vitro readouts and 

advanced in vivo imaging technologies. 

According to the company, the newly reported biologic 

pathway relates to monocyte deployment from the spleen 

to inflammatory sites, including myocardial infarction. The 

findings are expected to open up new areas of research and 

potentially advance therapeutic approaches to key disease 

areas including inflammation and myocardial injury, VisEn 

said. 

Peterson told Medical Device Daily that the paper validates 

the company’s technology. 

“What this paper says is ‘we’re not at the level of imaging 

anymore where we’re just satisfied with making pretty 

pictures’ and really that’s where imaging started . . . we’re 

moving well beyond that and have been moving well 

beyond that for a number of years,” Peterson said. 

In the Science report, titled “Identification of Splenic 

Reservoir Monocytes and Their Deployment to 

Inflammatory Sites,” the researchers found that monocytes 

were held in concentration in the spleen and released to 

injured tissue sites in the body to participate in wound 

healing. As presented in the findings, the reporting scientists 

discovered and detailed the biologic pathway through 

the use of a series of advanced and integrated in vitro 

assays, microscopic readouts, and in vivo imaging methodologies, 

including magnetic resonance (MR) imaging combined 

with quantitative fluorescence molecular tomographic 

(FMT) imaging. Used together in a series of “novel” 

scientific models, the researchers developed correlated 

data sets to both identify this previously unidentified 

splenic reservoir of monocytes, and demonstrate the 

monocyte deployment to inflammatory sites in vivo. In the 

in vivo data analysis, non-invasive, quantitative FMT imaging 

using novel fluorescent molecular imaging agents, 

combined with MR imaging, clearly demonstrated not only 

the location, but also the biological activity of the recruited 

splenic monocytes at the disease site, thus helping to confirm 

“unambiguously the fate of monocytes from the 

151 

spleen to the heart,” according to the paper. 

“FMT technology is quantifiable, [it’s] not just about 

making a pretty picture. You can answer important questions 

about important disease biology,” Peterson said. 

According to VisEn, its in vivo fluorescence imaging 

technologies, including its Fluorescence Agent Portfolio 

and its FMT imaging systems, provide robust fluorescence 

molecular imaging performance in identifying, characterizing 

and quantifying ranges of disease biomarkers and therapeutic 

efficacy in vivo. VisEn’s FMT systems and agents are 

used by research institutions and pharmaceutical companies 

worldwide in applications including cancer research, 

inflammation, cardiovascular, skeletal and pulmonary disease, 

the company said. VisEn said it also works with large 

pharmaceutical and clinical partners to design ranges of 

tailored molecular imaging agents and applications 

designed for their specific pre-clinical and clinical research 

areas. 

“We see the integration of in vitro and in vivo readouts 

becoming increasingly important in research today, and we 

are extremely pleased that our FMT quantitative in vivo 

imaging technology and activatable in vivo imaging agents 

were able to help the research team answer some of the 

key questions about this important biologic pathway in 

vivo,” Peterson said. “When cardiac molecular imaging data 

from the FMT was combined with MRI imaging, the 

researchers were able to create a fused molecular and 

anatomical imaging map of the heart to identify and quantify 

biomarkers of monocyte activity in vivo. These results 

enabled an important data correlation that further 

enhanced the integrated array of in vitro assays and 

microscopy-based readouts of this important pathway.” 

Peterson noted the importance of being able to simultaneously 

image multiple different types of biology by 

using the right types of imaging agents and said that is a 

big part of what VisEn does. “We are generating and developing 

new research tools . . . this particular paper highlights 

looking at two different types of biologies . . . you can even 

go more diverse than that,” he said. “We have four lasers 

now being put on our imaging system, so you can look at 

three or four different biologies at the same time which 

gives you a much more clear, albeit complex, picture of disease 

biology,” Peterson said. 





152 

Nanotubes plus radiation may be 

the key to a kidney cancer cure 



An introductory talk from the director of the Center 

for Nanotechnology and Molecular Materials at Wake 

Forest University’s (Winston-Salem, North Carolina) 

School of Medicine about the value of nanomaterials 

sparked an idea among researchers that may now lead to 

an effective kidney cancer cure. 

Researchers there have just reported using nanotubes 

to eliminate cancerous kidney tumors and insure that they 

don’t return. Nanotubes are injected into the tumors and 

heated with a laser to effectively kill tumors in nearly 80% 

of mice tested, suggesting a potential future cancer treatment 

for humans. 

“Our lab is interested in relationships between iron and 

cancer,” Suzy Torti, PhD, a professor of biochemistry at WFU 

School of Medicine, told Medical Device Daily. “We came to 

study nanotubes because of the proximity of the 

Nanotechnology Center. A talk by the director, David 

Carroll, got everybody here excited. These particles have 

some iron and that can be used as contrast agents and 

those were our initial thoughts, but it became clear that 

nanomaterials were useful for more than that.” 

The work, reported in the August issue of the 

Proceedings of the National Academy of Sciences (PNAS) 

reports how carbon-based multi-walled nanotubes 

(MWCNTs), which contain several nanotubes nested within 

each other, were injected into tumors and then zapped with 

a 30-second dose of near-infrared radiation. 

Rather than delivering the nanotubes systemically, 

Torti’s team injected them directly into tumors, so that “. . . 

they didn’t have to find the tumors. That was a first step – 

just proof that they can be tumor-ablative agents if you can 

get them to the right place at the right time. 

“Then we exposed it to a near infrared laser radiation,” 

she said. “When you do that, nanotubes begin to vibrate 

pretty fast, creating heat. It’s localized to where the infrared 

radiation hits the tubes causing death of tumor cells.” 

For the study, Torti’s team reported that mice who 

received no treatment for their tumors died about 30 days 

into the study. Those that received the nanotubes alone or 

had laser treatment alone survived for a similar length of 

time. Tumors disappeared for 80% of mice that received the 

MWCNTs combined with laser treatment. 

Nine months later, many of the treated mice remained 

tumor free. 

“Nanotubes are pretty efficient at absorbing light . . . a 

broad absorption spectrum relative to other materials,” 

Torti said when asked why she chose nanotubes rather 

than another nanomaterial. “They can also absorb nearinfrared 

radiation. They’re pretty efficient at absorption 


and reduce the amount of laser light needed to excite 

them.” 

Torti and her colleagues chose to try the treatment on 

kidney tumors because, “People have tried radio frequency 

ablation, which is a similar idea. A tip is inserted into the 

kidney to generate heat. But there are shortcomings. 

Although ablation is successful, the probe is not the best; 

there is seeding of tumors along the tumor trace. Using 

MWCNTs plus near-infrared radiation provides more diffuse 

heating.” 

Thermal ablation treatments for human tumors currently 

include radio frequency ablation, which applies a single-point 

source of heat to the tumor rather than evenly 

heating the tumor throughout, like the MWCNTs can do. 

Torti said her team was able to watch the tumors 

shrink, day by day, until they disappeared. 

“Not only did the mice survive, but they maintained 

their weight, didn’t have any noticeable behavioral abnormalities 

and experienced no obvious problems with internal 

tissues,” she said. “As far as we can tell, other than a 

transient burn on the skin that didn’t seem to affect the animals 

and eventually went away, there were no real downsides 

– that’s very encouraging.” 

Torti’s team noted the thermal effects generated by 

MWCNTs had added benefits, beyond the ablation of cancerous 

tumors. “For example, hyperthermia can increase the permeability 

of tumor vasculature, which can enhance the delivery 

of drugs into tumors, as well as synergistically enhance 

tumor cytotoxicity when combined with chemotherapy or 

radiotherapy,” according to the PNAS article. 

The next step is to explore systemic delivery and use a 

“slightly less contrived system” so that kidney tumors are 

actually resident in the kidney, rather than a subcutaneous 

placement as was the case for this study, in order to move 

closer to clinical applications. 

The team will then begin toxicology and pharmacology 

studies. It’s unknown what happens to the nanotubes after 

they are used. Torti said she observed (anecdotally, but not 

reported) that a certain number do remain at the site. It’s 

not a bad thing, she said, because it provides an opportunity 

for retreatment with additional zaps of radiation if necessary. 

A grant from the National Cancer Institute 

(Bethesda, Maryland) and a private donation will keep the 

wheels turning on this research project for several more 

years. Torti estimates that it would take at least “a few more 

years” of work to test the new therapy before human trials 

could begin, “even if everything worked remarkably well.” 






New contraceptive may prevent 

HIV transmission, pregnancy 



Women may someday have a new birth control option 

designed to not only prevent unplanned pregnancy but 

also block the transmission of the HIV virus. Researchers 

from Weill Cornell Medical College (New York) have 

published results showing that a new contraceptive device 

may do just that. The results are published in the latest 

issue of the journal AIDS. 

The new device is a vaginal ring that releases multiple 

types of non-hormonal agents and microbicides, which 

would prevent conception as well as sexually transmitted 

HIV infection, according to the researchers. Worldwide, 

there are about 5 million new infections and 3 million 

deaths a year due to HIV/AIDS. If proven successful in 

future clinical trials, the new device could empower women 

to effectively and conveniently protect themselves from 

unintended pregnancy and sexually transmitted infection. 

The ring may also someday represent a novel method to 

prevent sexually transmitted infections for those with aversion 

to currently available methods, with hormonally 

derived active agents, or with allergies to latex condoms, 

the researchers said. 

“This device is a new approach to birth control, 

because it avoids the long-term use of hormonal methods 

that have been associated with increased risk of certain 

cancers,” said Brij Saxena, MD, lead author and the Harold 

and Percy Uris Professor of Reproductive Biology and professor 

of endocrinology in the department of obstetrics 

and gynecology at Weill Cornell. “At the same time, this is 

the first device to simultaneously offer the possibility to 

prevent unintended pregnancy and HIV transmission.” 

Saxena told Medical Device Daily that long-term use of 

hormones has side effects. Women are always at risk for 

infection with HIV, he said, because it is transmitted during 

heterosexual contact. With this vaginal ring, “women will 

have control themselves to protect them [from] unintended 

pregnancy and HIV infection. He said the device can provide 

sustained release of both contraceptives and microbicide 

simultaneously in vitro at the concentration “which is 

efficacious and significantly below the toxic levels.” 

The vaginally inserted ring is incorporated with multiple 

antiviral drugs that prevent HIV infection and are timereleased 

over a period up to 28 days. The compounds tested 

are a newly developed anti-HIV agent, boc-lysinated 

betulonic acid, TMC120 (dapivirine), PMPA, and 3’-azido-3’- 

deoxythymidine (AZT or zidovudine), which, when combined, 

were found to block infection in human cells 

exposed to the virus in a laboratory setting. 

“No one has ever conquered a viral epidemic with treatment, 

so prevention is the most effective option. Ideally, an 

153 

HIV vaccine is the most desirable method, but that is not 

foreseeable in the near future,” said Jeffrey Laurence, MD, 

co-author of the study and attending physician at NewYork- 

Presbyterian Hospital/Weill Cornell Medical Center. “The 

next best thing would be something that would prevent 

infection and put the power in the susceptible female partner’s 

control. That’s the potential a device such as this can 

offer.” 

When asked to provide a crystal-ball guess as to when 

this new device might be available to women in the U.S., 

Saxena said it may be a couple of years. He said the compounds 

used in the device are natural materials that are 

already FDA approved for human use. However, the device 

itself may still be subject to FDA approval, he noted. 

“The combination of these antiviral drugs has proven 

to be potent agents that may block infection by the HIV 

virus,” Saxena said. The ring is also incorporated with compounds 

that prevent conception by arresting sperm motility, 

raising vaginal mucous viscosity, and sustaining the 

acidity of the vagina in which sperm do not survive. 

Traditionally, similar devices have used hormonal compounds 

that have been linked to increased risk of breast 

and cervical cancers, or spermicidal compounds that kill 

sperm, but may lead to irritation and inflammation, according 

to the researchers. Past findings published in the journal 

Contraception found the device to be highly effective in 

animal models and in laboratory testing. 

The study was supported by grants by the National 

Institutes of Health, International Partnership for 

Microbicides (Silver Spring, Maryland) and BioRings (New 

York). Collaborators on the study include Dr. Young Han and 

Mukul Singh, PhD, from Weill Cornell, Dr. Dingyi Fu and Dr. 

Premila Rathnam, formerly of Weill Cornell, and Sidney 

Lerner from BioRings. Saxena and Singh are vice presidents 

at BioRings and along with Lerner, president of BioRings, 

are coinventors and owners of U.S. and foreign patents on 

the technology used in this research. Cornell Research 

Foundation owns pending patent applications related to 

the research. 





154 

BrainPort helps blind mountainclimber 

learn to ‘see’ via tongue 



Erik Weihenmayer has climbed the Seven Summits – the 

highest peaks on each of the seven continents – including 

Mount Everest. This world adventurer’s quests are made 

even more remarkable by the fact that he has conquered 

them all while visually guided by others. 

In addition to making headlines for being the first blind 

man in history to reach the top of Everest in 2001, 

Weihenmayer has also been in the spotlight lately for his 

involvement with BrainPort, a device designed to allow 

blind people to “see” with their tongue. 

The device, being developed by Wicab (Middleton, 

Wisconsin) and funded by the National Eye Institute (NEI; 

Bethesda, Maryland) uses sensory substitution – stimulating 

one sense, such as touch, to take the place of another, 

such as sight – an idea introduced in the late 1960s by Paul 

Bach-y-Rita, MD. Bach-y-Rita died in 2006 but his research 

lives on through Wicab, a company he established in 1998. 

In addition to the BrainPort vision device, the company is 

also developing a BrainPort balance device based on the 

same technology. 

“There are two different pieces to what [Bach-y-Rita] 

believed and what I think is true,” Bob Beckman, president/CEO 

of Wicab told Medical Device Daily. “The sensors 

– your eyes or your ears – can be replaced with alternate 

sensors and also the brain is not hardwired. You do not 

have to go through the optic nerve to relay visual information 

to the brain . . . you can go through the tongue.” 

Recently Weihenmayer demonstrated the BrainPort on 

the Today Show, using the device to read numbers on black 

and white flash cards. With a camera mounted on his head 

sending pulses to his tongue, he is able to interpret and 

thereby determine the field of vision in front of him. 

According to his web site, he has also used the device to 

read words on note cards, play games with his daughter 

such as tic-tac-toe, and find holds while rock climbing. 

The camera acts as the user’s eyes, gathering white, 

gray and black pixels of visual information. A computer 

translates this information to electrical impulses, which it 

then displays on the tongue in the form of an array of electrodes. 

Strong vibrations on the tongue represent white 

pixels, medium-strength vibrations represent gray pixels 

and no vibrations represent black pixels. Blind people learn 

to use that information to gain perception about their surroundings, 

Beckman said. A few examples of what a blind 

person could learn to do with the device are walk a sidewalk, 

read signs in a hallway, and throw a ball into a basket. 

Aimee Arnoldussen, a neuroscientist and BrainPort 

researcher who worked with Bach-y-Rita, appeared on the 

Today Show with Weihenmayer. She said that eventually the 


camera part of the device could be shrunk to fit in a pair of 

glasses and that the visual information it collects might be 

transmitted wirelessly to a retainer-like device that sits on 

the roof of the person’s mouth. 

Michael Oberdorfer, PhD, of the Division of Extramural 

Research at the NEI told MDD that the tongue – aside from 

serving us for taste – is very sensitive to touch. “If you’ve 

ever had a small seed stuck between your teeth you know 

what I’m talking about,” he said. 

Oberdorfer said the technology behind the BrainPort 

vision device delivers a “very gentle stimulation” to the 

user’s tongue, which that person can adjust to get input 

from the video camera. 

The device would not work for a person who is considered 

legally blind but has some vision, Oberdorfer said, 

because the user would get competing input from their 

eyes and the device. Thus, it only works for individuals like 

Weihenmayer who are completely blind. 

While only about 3% or less of the U.S. population are 

totally blind, according to Oberdorfer, he says that is still a 

significant number of people who could someday benefit 

from this and other technologies. 

But using the device takes practice, Beckman said. He 

likened it to learning a new language and noted that it 

requires training in order for the blind person to interpret 

the tactile images being displayed on their tongue and 

transmitted to their brain. 

Wicab’s balance device is based on the same sensory 

substitution technology as the vision device, only it is 

designed for training patients with balance deficits due to 

chronic vestibular disorders. The BrainPort balance device 

provides information about head position through electrotactile 

stimulation of the tongue, Beckman said. That device 

consists of a controller – which includes patient controls, 

signal processors and microcontroller – and an intra-oral 

device, which includes a tilt sensor and an electrode array. 

Instead of a camera, the BrainPort balance device uses 

an accelerometer. During training sessions with this device, 

the patient places the electrode array on the tip of their 

tongue and slowly adjusts the signal intensity to a comfortable 

level, Wicab said. The accelerometer detects head 

and body movement when the patient leans forward, backward 

or to either side. This information is relayed by microprocessors 

directly to the tongue through the electrode 

array, according to the company. For example, if the patient 

sways to the left, the stimulus moves to the left side of the 

patient’s tongue. If the patient sways to the right, the stimulus 

moves to the right side of the tongue, Beckman said. 

Patients are told to focus on the stimulus and to adjust their 

body position with the goal of maintaining the stimulus on 

the center of their tongue. 

Beckman said Wicab has found that people learning to 

use the BrainPort balance device train best with their eyes 

closed and in a position which they find challenging. They 

are asked to maintain their balance for 20 minutes, he said. 




155 

Unlike the vision device, which is like learning a new language, 

Beckman said that learning to use the balance 

device is more intuitive. 

Wicab is running a controlled clinical trial with the 

BrainPort balance device, Beckman said, and the company 

expects to complete that trial by the end of the year. “We’re 

hopeful that we’ll have a significant difference between the 

active group and the controlled group,” he said. 

In terms of a commercial application, Beckman told 

MDD that the balance device has a lot more going for it than 

the vision device because there is a much broader patient 

population that could benefit from it. He said elderly people, 

stroke patients, and people with certain types of brain 

tumors could potentially use the balance device.

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