About 7 years after spinning out of medtech titan Medtronic (NYSE:MDT), Inspire Medical won FDA approval for its novel sleep apnea implant, a pacemaker-liked device designed to help keep airways open while patients sleep.
The technology is a significant leap from the CPAP face masks that dominate the standard of care for obstructive sleep apnea, a condition which affects an estimated 18 million in the U.S.
The Inspire device should be on the market by the second half of 2014, according to the company. The therapy has been available in the European Union since Inspire won CE Mark approval in December 2010.
Patients with OSA suffer from poor sleep because their airways involuntarily constrict and block breathing. The condition comes with an increased risk for heart attack, stroke, heart failure and hypertension, and can also disrupt day-to-day activities. Studies showing that patients with OSA are more likely to fall asleep while driving.
Inspire’s device combines an implanted pulse generator and a pair of leads to sense breathing patterns and deliver mild electrical shocks to keep airways open. The only external component is a hand-held remote used to activates the device before bed and deactivate after waking.
"This therapy represents a major advance in sleep apnea treatment for some patients who are unable to use or tolerate CPAP therapy," Yale School of Medicine professor Dr. Meir Kryger said in prepared remarks on behalf of Inspire. "Patients with moderate to severe OSA who are not on effective treatment are at an increased risk for cardiovascular disease, accidents and death. There is a significant need for safe, effective and well-tolerated new treatments in the sleep medicine field."
Inspire Medical spun out of Medtronic in 2007, taking with it therapy concepts stemming from trials begun in 1998. Medtronic still holds a minority stake in the company and manufactures the OSA implants.
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