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.

Related Posts with Thumbnails

Tagged with:

Filed under: Cardiovascular DiseaseDaytime SleepinessObstructive Sleep ApneaPress ReleaseSleepSleep ApneaSleep Apnea EventsSleep Apnea NewsSleep Apnea SurgerySleep Apnea TreatmentSleep Disordered BreathingSleep Problems

Like this post? Subscribe to my RSS feed and get loads more!