The US Food and Drug Administration (FDA) has granted 510(k) approval to ApniCure's portable Winx sleep therapy system for the treatment of obstructive sleep apnea (OSA).
The FDA approval of Winx was based in part on clinical data from a multi-center, prospective clinical ATLAST study which enrolled patients with mild, moderate or severe OSA.
Study results will be presented at the upcoming 2012 American Thoracic Society (ATS) Conference in San Francisco, California, US on 21 May 2012.
The Winx sleep therapy system is a home-use device designed to provide a comfortable sleeping experience, allowing users to breathe naturally without a mask.
The Winx system utilizes a proprietary platform technology called oral pressure therapy (OPT) which delivers oral vacuum 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, increase the size of the airway and allow for natural breathing to occur during sleep.
ApniCure Steve Carlson president and CEO said, "We anticipate a commercial launch of the Winx system in select U.S. markets this year, with broader distribution in 2013."