Sommetrics negative pressure aerSleep II device has received FDA “Breakthrough Device” designation. The breakthrough program allows for additional FDA feedback to sponsors during the pre-marketing phase but does not alter the basic requirements for market authorization. It is intended to help patients gain more timely access to products that have the potential to provide more effective therapy than currently available options for medical conditions which are either life-threatening or irreversibly debilitating.
“This designation recognizes the real promise of aerSleep II as a first-in-class therapy for people with sleep apnea who are unable to benefit from current therapies,” says Kingman Strohl, MD, program director, sleep medicine, University Hospital, Cleveland, and professor of medicine, Case School of Medicine, in a release. “AerSleep II is simple to use and comfortable, with new design features which can translate into effectiveness and better compliance with treatment. Also, unlike some other alternatives to standard CPAP therapy, aerSleep II has been shown in previous clinical studies to be effective in patients with all degrees of sleep apnea severity.”
AerSleep II applies negative pressure over the external surface of the neck to hold the airway open during sleep. It is a self-contained unit with an integral vacuum pump. The unit is portable and is held in place without the need for a retaining strap. In previous clinical studies, there was a strong preference for aerSleep over other therapies like CPAP and oral devices.
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Eric Koehler, Sommetrics’ vice president for clinical operations and regulatory affairs, says in a release, “We are pleased to see aerSleep II receive this designation, which allows us to have more streamlined and frequent interactions with FDA in a joint effort to bring this much needed device to the market as soon as possible. Sleep apnea remains a major public health problem with more than 20% of adults afflicted, and only a small fraction receiving effective therapy. We expect aerSleep II to address this extraordinary unmet need for better tolerated and effective options to treat sleep apnea, a life-threatening disease with important comorbidities.”