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FDA clears InnoMed Technologies' Nasal-Aire II Petite for pediatric use

Published on December 3, 2009 at 11:27 AM · No Comments

It is estimated that almost 2 million kids in the United States alone suffer from obstructive sleep apnea (OSA) and may require continuous positive airway pressure (CPAP) therapy. This number has increased more than 10 times in the last 30 years, thanks mainly to the nation’s obesity epidemic. However, pediatric OSA appears to be an underserved and misunderstood market, reports the American Academy of Sleep Medicine (AASM). That’s because primary care physicians often misdiagnose daytime sleepiness as related to bedwetting, nightmares or some other common childhood issue - not OSA. That is expected to change as physicians become more aware of OSA in children and there will be a bigger need for comfortable treatment methods.

Pediatric CPAP mask/interface options are very limited. Until now, the only available options were traditional “over the nose” nasal masks, that make a large percentage of kids feel claustrophobic and not cooperate with CPAP therapy despite parental support. This constraint has largely now been eliminated with the FDA 510(k) clearance of the Nasal-Aire® II Petite, manufactured by InnoMed Technologies, for use on children the age of 7 years and older or weighing more than 40 lbs. InnoMed Technologies, Inc., a Mergenet Solutions, Inc. subsidiary, competes with such companies as ResMed (RMD-NYSE), Philips Respironics (PHG-NYSE), GE Healthcare (GE-NYSE), Covidien (COV-NYSE), CareFusion Corporation (CFN-NYSE), among others.

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