MEDICAL DEVICE INNOVATION - Medical Device Daily
MEDICAL DEVICE INNOVATION - Medical Device Daily
MEDICAL DEVICE INNOVATION - Medical Device Daily
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<strong>MEDICAL</strong> <strong>DEVICE</strong> <strong>INNOVATION</strong> 2010<br />
15<br />
breakthrough technology” targeting a disease need that is<br />
“indisputable.”<br />
The total clinical experience with the Alair system<br />
includes, to date, more than 800 bronchial thermoplasty<br />
bronchoscopies with long-term follow up data available.<br />
“We have,” French said, ‘an extraordinary amount of clinical<br />
experience across disease severity and follow-up out to<br />
five years.”<br />
“We are encouraged by the consistency of the data that<br />
we have seen across four clinical studies in patients with<br />
asthma,” said Gerard Cox, professor of medicine at<br />
McMaster University (Hamilton, Ontario), and an investigator<br />
in the company’s four bronchial thermoplasty studies.<br />
“The results of the randomized trials show a significant and<br />
persistent improvement in asthma control and quality of<br />
life in patients with severe asthma.”<br />
The singular status of the company’s technology perhaps<br />
works to some disadvantage by not having reimbursement<br />
codes in place, but France noted the large benefits<br />
of the device – reductions in doctors’ visits, emergency<br />
room trips (estimated at 2 million yearly) and hospitalizations<br />
(an estimated 500,000 yearly) and the need for fewer<br />
drugs. And he noted that the device addresses one of those<br />
chronic components of illness that soaks up 80% of the<br />
healthcare dollar.<br />
All of these advantages point to likely coverage by the<br />
Centers for Medicare & Medicaid Services.<br />
He also suggested that while the company is initially<br />
focused on severe disease, this could be expanded to more<br />
moderate illness.<br />
The question of to usefulness in children is more tenuous,<br />
France acknowledged. He called that population “a different<br />
animal” with a different anatomy, requiring considerably<br />
more modification and testing of the device.<br />
France said that Asthmatx is hoping for FDA approval<br />
and then U.S. product roll-out early in 2010 and that this will<br />
drive ramp-up of infrastructure for sales in Europe, where<br />
the system already has the CE mark.<br />
(This story originally appeared in the January 22,<br />
2009, edition of <strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong>.)<br />
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