Restore Medical has announced that it is starting clinical trials of combination therapy of its Pillar palatal implants coupled with a continuous positive airway pressure mask to reduce symptoms of sleep apnea, and let people get to sleep. We initially reported about the Pillar Palatal Implant System, Fewer Obstructions for Pillar System, back in 2005.
This clinical study is expected to enroll up to 100 patients, and is one of the first multi-disciplinary clinical studies involving active collaborations between sleep medicine physicians and otolaryngologists to evaluate the use of a minimally-invasive procedure to treat the palatal component of OSA in combination with CPAP. This clinical study has been structured as a Level 1 evidence-based medicine, prospective, randomized, placebo-controlled study and is being conducted at eight sleep centers across the U.S. This study is expected to be completed by mid-2008 and the clinical results, if favorable, will be included in an application to the FDA to expand the approved clinical indications for Pillar palatal implants to include use with CPAP.
Press Release: Restore Medical Begins Clinical Study to Evaluate Pillar Palatal Implants in Combination with Continuous Positive Airway Pressure
Video of the Pillar implant system (Windows Media format)…
