Moving the HME Industry Forward

Respiratory/Sleep

FDA Approves New Sleep Apnea Treatment

May 12, 2014

MAPLE GROVE, MN – An implantable, pacemaker-like device that mildly shocks a nerve in the neck has received Food and Drug Administration (FDA) approval as a new treatment for sleep apnea.

As reported in the Star Tribune and several media outlets, Inspire Medical Systems’ “Upper Airway Stimulation” therapy shocks a nerve in the neck to keep breathing passageways open without waking the patient. Tim Herbert, the company’s chief executive, said in an interview that the $30K device is being marketed as another sleep apnea option for those who are unable to comply with CPAP.

Herbert says the item “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.”

Reporter Steve Alexander writes that the Inspire product “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.”

“We treat moderate to severe sleep apnea, in which sleeping people stop breathing 20 to 65 times per hour,” said Herbert in the article. “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 reportedly manufactured for 39- employee Inspire by Fridley-based Medtronic, which spun off Inspire Medical as a private company in 2007 and holds a minority stake in it.