Siesta Medical, which develops minimally invasive implants and tools for obstructive sleep apnea, landed addtional FDA clearances for its Encore tongue suspension system.
The regulartory win makes Encore tongue suspension system the only multiple suspension loop and fully adjustable system on the market, according to a press release.
"Siesta believes the Encore System is a clinically and cost effective surgical option for treating OSA patients unable to comply with CPAP use," president & CEO Peter Martin said in prepared remarks. "We are gratified that our users have consistently endorsed the clear product and procedural advantages the system delivers."
The Encore system, a minimally invasive tongue suspension device, controls the airway space behind the tongue, allowing physicians to place multiple suspension loops during and after the procedure, the company said.
The common treatment for OSA is continuous positive airway pressure. More than 1 million people in the U.S. are diagnosed with OSA and nearly 100,000 surgical procedures are performed annually, according to the release.
Siesta Medical’s Encore tongue suspension system initially won FDA clearance in 2011.
Siesta said doctors are limited to a single suspension loop with a fixed amount of tension during traditional tongue suspension procedures, which may cause residual airway obstruction.
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