Encore Tongue Suspension System For Treatment of Obstructive Sleep Apnea
Siesta Medical, Inc. , a developer of minimally invasive surgical solutions for obstructive sleep apnea (OSA), announced today that it has received FDA 510(k) clearance for its Encore™ Tongue Suspension System for the treatment of obstructive sleep apnea. Obstructive sleep apnea (OSA) is a major heath problem in the United States. As many as 17 million people in the United States have moderate to severe OSA, which is characterized by frequent awakening during sleep, heavy snoring and daytime sleepiness. If left untreated, OSA has been implicated in the increased risk for cardiovascular disease, including hypertension and heart failure. Despite its prevalence and role as a cardiovascular risk factor, OSA remains largely under diagnosed.
The first line and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated three million Americans. While effective, CPAP is difficult for patients to use.
Surgical therapy for OSA is less common than CPAP therapy. Although there are approximately one million new diagnoses of OSA in the U.S. each year, there are only approximately 100,000 surgical treatments for OSA performed annually. Surgery is less prevalent as most current procedures are not highly effective, are painful to the patient and do not address tongue based obstructions. The tongue is implicated in approximately 80 percent of OSA.
The EncoreTM System is used in a minimally invasive surgical procedure where the tongue is suspended forward with the intent of preventing collapse of the airway during sleep. The procedure is performed under local or general anesthesia by Ear, Nose and Throat Specialists, also known as Otolaryngologists. During the procedure, an intra-tissue suture passer is used to place a suspension loop in the tongue which is then attached to the base of the chin with a knotless bone anchor. The EncoreTM System greatly simplifies tongue suspension and provides the surgeon excellent control of positioning and tensioning of the suspension loop.
Filed under: Cardiovascular Disease • Daytime Sleepiness • Obstructive Sleep Apnea • Press Release • Sleep • Sleep Apnea • Sleep Apnea Events • Sleep Apnea News • Sleep Apnea Surgery • Sleep Apnea Treatment • Sleep Disordered Breathing • Sleep Problems
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