The US Food and Drug Administration (FDA) has granted ApniCure 510(k) clearance to market its Winx Sleep Therapy System in the United States. The Winx system is an innovative device designed to be comfortable and easy to use while allowing users to breathe naturally without a mask.
“The Winx system is a first-of-its kind, patient-friendly treatment option for OSA patients,” said Steve Carlson, president and CEO of ApniCure. “We anticipate a commercial launch of the Winx system in select US markets this year, with broader distribution in 2013.”
Winx uses a proprietary platform technology called oral pressure therapy (OPT) to treat OSA. OPT is a light, oral vacuum delivered by a quiet console through a slim tube connected to a soft, flexible mouthpiece. The mouthpiece and vacuum work together to gently pull the soft palate forward and stabilize the tongue, increasing the size of the airway and allowing for natural breathing to occur during sleep.
The FDA clearance of Winx was based in part on clinical data from the ATLAST study, a multi-center, prospective clinical trial of patients with mild, moderate, or severe OSA. Study results were presented as a late-breaking abstract at the 2012 American Thoracic Society (ATS) Conference in San Francisco.