For CPAP use in children over the age of seven years
InnoMed Technologies (InnoMed) has received US Food and Drug Administration (FDA) 510(K) approval for the Nasal Aire II Petite mask for CPAP use in children over the age of seven years.
The company claims that 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 seal through the nasal prongs.
This non-claustrophobic design is likely to result in an increase in the compliance rate of children to CPAP therapy, and is expected to make it easier for both clinicians and parents to treat pediatric OSA without surgery.
David Randall, director of Business Development at InnoMed Technologies, said: “Some healthcare professionals have been using the Nasal-Aire II Petite off-label because of its non-claustrophobic design. 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.”
The company said that in addition to treating pediatric OSA, there is a 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.
When NIV fails, the only option available to the clinician is intubation, which brings with it, a whole host of complications, along with the risk of ventilator associated pneumonia (VAP).