ImThera Medical said the FDA approved its investigational device exemption application to initiate a clinical study for its Aura6000 System for obstructive sleep apnea.
Data from the study, which will track patients with moderate-to-severe obstructive sleep apnea, will be used to support a pre-market approval application, according to a press release.
The Aura6000 System consists of a small pulse generator placed under the skin near the collarbone and a multi-electrode lead implanted in the neck. The electrodes send mild pulses to the tongue’s nerves during sleep to prevent it from collapsing into the upper airway.
ImThera said the IDE study will test the system on sleep apnea patients who are unable or unwilling to try treatments such as positive airway pressure therapy. The product has already received CE Mark clearance in Europe, according to the release.
Although up to 28 million Americans are believed to suffer from sleep apnea, only about 25% are currently receiving therapy, according to the company.