MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
superDimension’s iLogic locates
lung spots previously unreachable
By LYNN YOFFEE
Medical Device Daily Staff Writer
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
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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
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