As part of the THN3 Clinical Study, ImThera Medical Inc’s aura6000 System—a hypoglossal nerve stimulator for sleep apnea–was implanted into the first two patients. ImThera Medical is a privately held global medical device company. The surgeries were performed by Sam Mickelson, MD, at the Atlanta Outpatient Surgery Center in Sandy Springs, Ga.
The aura6000 System is based on ImThera’s proprietary THN Sleep Therapy technology. The system consists of two implantable components, a small rechargeable pulse generator placed under the skin near the collarbone, and a multi-electrode lead placed in the upper neck. THN Sleep Therapy stimulates the hypoglossal nerve, increasing muscle tone of multiple tongue muscles and preventing the tongue from collapsing into the upper airway during sleep.
“The procedures were simple, fast, and considerably less invasive than other sleep apnea surgeries,” says Mickelson, of Advanced Ear Nose & Throat Associates, medical director of Advanced Sleep Centers, Atlanta, and a study investigator, in a release. “The procedures took between 60 and 90 minutes, and both patients went home less than 3 hours later.”
The subjects, aged 48 and 61, suffered from obstructive sleep apnea for more than 7 and 25 years respectively and were unable to attain lasting benefit from CPAP or other surgical procedures.
“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,” says Alan Schwartz, MD, professor of medicine and medical director, Johns Hopkins Sleep Disorders Center at Bayview, Baltimore, Md, and principal investigator of the THN3 study. “ImThera’s device offers a unique approach to hypoglossal stimulation with its ability to selectively stimulate several muscles individually.”
The THN3 Study (Targeted Hypoglossal Neurostimulation Study #3) is a FDA-approved, randomized, controlled, prospective, multi-center clinical trial. It is being conducted at leading medical centers in the United States and Europe.
“This is a major milestone on our journey to make this life-changing therapy available to the millions of Americans with sleep apnea,” says Marcelo Lima, President and CEO at ImThera Medical. “We look forward to the completion of the study, and the filing of a PMA application with the Food and Drug Administration.”