Nasal-Aire(R) II Petite Receives FDA 510(k) Clearance For Pediatric Use

Main Category: Ear, Nose and Throat
Also Included In: Regulatory Affairs / Drug Approvals;  Sleep / Sleep Disorders / Insomnia;  Pediatrics / Children's Health
Article Date: 10 Dec 2009 - 15:00 PDT


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.

The Nasal-Aire® II Petite is the first and only nasal prong/nasal cannula/nasal pillow type interface, cleared for use in children in the home. It wears like an oversized nasal cannula, providing a comfortable seal through the nasal prongs. This non-claustrophobic design is likely to result in a substantial increase in the compliance rate of children to CPAP therapy, making it easier for both clinicians and parents to treat pediatric OSA without surgery. "Some healthcare professionals have been using the Nasal-Aire® II Petite off-label because of its non-claustrophobic design," said David Randall, Director of Business Development at InnoMed Technologies. "We expect the FDA 510(k) clearance to boost Nasal-Aire® II Petite sales among healthcare professionals who refuse to use products off-label and finally offer them a compelling interface option to choose CPAP therapy over surgery."

In addition to treating pediatric OSA, there is also an immense need for a comfortable, non-claustrophobic interface to provide positive pressure based non-invasive ventilation (NIV) in both acute care and homecare settings. The Nasal-Aire® II Petite has received 510(k) clearance for this application as well. It is common knowledge amongst clinicians that the NIV interface is a very important, if not the most important factor in the success of NIV. When NIV fails, the only option available to the clinician is intubation, which brings with it, a whole host of complications, not to mention the risk of ventilator associated pneumonia (VAP). Hence, the availability of a 510(k) cleared interface such as Nasal-Aire® II Petite is likely to positively influence the outcomes with pediatric NIV.

Source
InnoMed Technologies, Inc.

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