Siesta Medical, a healthcare products company based in Los Gatos, California, announced that the United States Food and Drug Administration granted additional approvals for the company’s Encore system, a device for the treatment of obstructive sleep apnea.
According to a press release by the company, the Encore sleep apnea system is the first-in-class medical device to receive approval from the FDA. The device uses a tongue suspension system to help ensure a non-obstructed throat when sleeping. With the device, physicians can place multiple suspension loops in a patient’s throat.
Peter Martin is the CEO and president of Siesta. In prepared remarks, he said, "Siesta believes the Encore System is a clinically and cost effective surgical option for treating OSA patients unable to comply with CPAP use." He continued, "We are gratified that our users have consistently endorsed the clear product and procedural advantages the system delivers."
Obstructive sleep apnea is traditionally treated with continuous air passage pressure. An estimated one million people in the U.S. currently suffer from sleep apnea, and approximately 100,000 surgical operations are performed every year to treat this health issue. With traditional treatment systems, physicians can only place one suspension loop with a non-variable amount of tension in a patient. Over time, this can lead to residual airway obstruction.
Siesta Medical received its first FDA approval for the Encore system in 2011.