MEDICAL DEVICE INNOVATION - Medical Device Daily

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Trials to start for ImThera’s
neurostimulator device for OSA
By LYNN YOFFEE
Medical Device Daily Staff Writer
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
MEDICAL DEVICE INNOVATION 2010
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.
(This story originally appeared in the Oct. 2, 2009, edition
of Medical Device Daily)
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