Inspire Medical Systems is getting the FDA treatment, landing a date next month with the Anesthesiology & Respiratory Therapy Devices panel to undergo review of the company’s implanted Inspire II Upper Airway Stimulator for treatment of obstructive sleep apnea.
The device is a permanent implant designed to stimulate nerves associated with the upper airway in order to keep the airway open during sleep. The implant delivers mild electrical stimulation to the hypoglossal nerve, preventing the tongue from obstructing breathing.
Patients can control the device with a hand-held programmer, and, unlike other surgical measures for treatment of sleep apnea, the Inspire II doesn’t require removal or permanent alteration of any parts of the face or airway.
The FDA’s panel of expert advisors will meet February 20 from 8 a.m. to 6 p.m., according to an agency notice.
Inspire Medical was formed in 2007 from intellectual properties and technologies spun out from Minnesota medtech titan Medtronic (NYSE:MDT). Inspire won CE Mark approval in the European Union in 2010.