Siesta Medical Inc, a provider of minimally invasive surgical implants and tools for obstructive sleep apnea (OSA), has been granted additional FDA clearances for its Encore Tongue Suspension System.
Siesta’s Encore System simplifies and improves the control of tongue suspension, a minimally invasive treatment for OSA recently endorsed by the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) as an effective treatment used to manage patients suffering from OSA. The Encore’s latest FDA clearances make it the only multiple suspension loop and fully adjustable tongue suspension system on the market.
Traditional tongue suspension has been limited to the placement of a single suspension loop with a fixed amount of tension. This may result in residual airway obstruction behind the tongue base or a suboptimal amount of suture tension. Siesta’s Encore System overcomes this limitation with unique suture passer and bone anchor technology, giving the physician the freedom to place multiple suspension loops that can have their tension easily adjusted during and after the procedure.
“Siesta believes the Encore System is a clinically and cost effective surgical option for treating OSA patients unable to comply with CPAP use,” said Peter Martin, president and CEO of Siesta Medical Inc. “We are gratified that our users have consistently endorsed the clear product and procedural advantages the system delivers.”
The Encore System is used in a minimally invasive surgical procedure where the tongue is suspended forward with the intent of preventing its collapse into the airway during sleep. The procedure is performed under local or general anesthesia by otolaryngologists and takes typically less than 40 minutes to perform.