Inspire Medical Systems Inc has been given the go-ahead from regulators to sell the device in Europe and test it in the United States.
The U.S. Food and Drug Administration has given its approval to begin testing the device for safety and efficacy among patients with moderate or severe obstructive sleep apnea at several medical centers in the U. S. and Europe. Patients in the U.S. enrolled in its Stimulation Therapy for Apnea Reduction, STAR, pivotal trial are expected to begin being implanted early next year.
The device delivers a gentle electrical pulse during sleep to restore tone to the muscles that hold the tongue in place. More than 15 million adults in the United States are believed to suffer from obstructive sleep apnea.