Siesta Medical Inc, a developer of minimally invasive surgical solutions for obstructive sleep apnea (OSA), has received FDA 510(k) clearance for its Encore Tongue Suspension System for the treatment of obstructive sleep apnea.
The Encore 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 an otolaryngologist. 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 Encore System greatly simplifies tongue suspension and provides the surgeon excellent control of positioning and tensioning of the suspension loop.
Siesta Medical is currently planning a multicenter US post-marketing study.
“Treatment of obstructive sleep apnea is a significant and growing unmet clinical need. Achieving 510(k) clearance for the Encore System is an important milestone as we develop and commercialize minimally invasive, effective solutions for OSA,” said Peter Martin, president and CEO of Siesta Medical Inc. “We believe that the Encore System provides a significant new option to physicians for treating OSA in patients who may find compliance with CPAP difficult.”