FDA Approves Sleep Apnea Treatment From Inspire Medical

Inspire Medical Systems of Maple Grove received Food and Drug Administration (FDA) approval for a new treatment of sleep apnea, a condition in which sleeping people stop breathing because their airways temporarily close.

Sleep apnea causes people to sleep poorly and raises the long-term risk of heart attack, stroke, high blood pressure and heart failure.

Inspire Medical Systems’ “Upper Airway Stimulation” therapy uses an implantable, pacemaker-like device that mildly shocks a nerve in the neck to keep breathing passageways open without waking the patient, Tim Herbert, the company’s chief executive, told the Minneapolis (Minn.) Star-Tribune.

The method is considerably more expensive than existing treatments for sleep apnea, and as a result is intended only for patients who can’t adapt to those treatments, Herbert said.

The most common sleep apnea treatment is a $2,000 device prescribed to about 2 million Americans a year that uses a breathing mask and an air-pressure machine to keep breathing passages open.

The Inspire product, a pacemaker-sized unit that is implanted near the collarbone and connected by wire to the hypoglossal nerve under the chin, costs $30,000 for the device and the surgical implantation, Herbert told the newspaper. “We treat moderate to severe sleep apnea, in which sleeping people stop breathing 20 to 65 times per hour. Our market is maybe 400,000 patients a year in the U.S.”

Now that the treatment has received FDA approval, the device and therapy will be available for U.S. patients in the second half of the year, the company said.

The device is manufactured for 39-employee Inspire by Minneapolis-based Medtronic Inc., which spun off Inspire Medical as a private company in 2007 and holds a minority stake in it. Herbert is the former senior director of therapy development in Medtronic’s ventures group, which looks for new applications of the company’s medical technologies.

Medtronic decided to spin off the Inspire technology rather than spend money to develop it in-house, he said. Counting the five years it was under development at Medtronic before the spinoff, it took 12 years and $50 million to develop and test the product, Herbert said.