ImThera Medical said the 1st 2 U.S. patients in a clinical study of its Aura6000 sleep apnea therapy were successfully implanted with the device. The surgeries were performed by Dr. Sam Mickelson of Advanced Sleep Centers in Atlanta, Ga.
“The procedures were simple, fast and considerably less invasive than other sleep apnea surgeries. The procedures took between 60 and 90 minutes, and both patients went home less than 3 hours later,” Mickelson said in a prepared statement.
The Aura6000 system uses 2 implanted components, 1 near the collarbone and 1 in the upper neck. The therapy uses a multi-contact electrode and programmable pulse generator to improve muscle tone in certain tongue muscles to help control upper airway flow and reduce or eliminate sleep apnea, according to the company’s website.
“Too many patients are left untreated or under-treated by the currently available therapies for obstructive sleep apnea, and until now we’ve had very little to offer them. ImThera’s device offers a unique approach to hypoglossal stimulation with its ability to selectively stimulate several muscles individually,” added Dr. Alan Schwartz of Baltimore’s Johns Hopkins Sleep Disorders Center.
ImThera won FDA approval for the trial in November 2014 and has already received CE Mark clearance in Europe. The aura6000 system is currently commercially available in certain markets outside the U.S.