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FDA Clears Nasal-Aire II Petite Mask for Pediatric Use

Sleep Review, 12/03/2009 - The US Food and Drug Administration granted 510(k) clearance to the Nasal Aire II Petite mask for CPAP use in children over the age of 7 years. The mask is manufactured by InnoMed Technologies, Coconut Creek, Fla.

According to InnoMed, the Nasal Aire II Petite is the first and only nasal prong/nasal cannula/nasal pillow interface cleared for use in children. The fit of the mask is comparable to an oversized nasal cannula in order to provide a comfortable seal through the nasal prongs.

“Some health care professionals have been using the Nasal Aire II Petite off-label because of its nonclaustrophobic design,” said David Randall, director of business development at InnoMed. “We expect the FDA 510(k) clearance to boost Nasal Aire II Petite sales among health care professionals who refuse to use products off-label and finally offer them a compelling interface option to choose CPAP therapy over surgery.”

The Nasal Aire II Petite also received 510(k) clearance for positive pressure-based noninvasive ventilation (NIV) in both acute care and home care settings.