FDA Approves Implantable Device for Hard-to-Treat Sleep Apnea Sufferers

Inspire Medical Systems said Thursday that the FDA has approved its Inspire upper airway stimulation device for patients with moderate to severe obstructive sleep apnea who are unable to use continuous positive airway pressure.

The company plans to launch the device — the first of its kind for obstructive sleep apnea — during the second half of this year.

The fully implantable system includes a small generator, sensing lead and stimulation lead. There is also a small, external remote used to turn the therapy on and off. When activated, Inspire sends mild pulses to key airway muscles, keeping the airway open during sleep.

FDA approval was based on the pivotal STAR clinical trial, which showed a 68 percent reduction in sleep apnea events and 70 drop in oxygen desaturation events in patient getting UAS therapy. Patients also had “significant improvement in daytime functioning,” as measured by two validated questionnaires, the Minneapolis devicemaker said.

Meir Kryger, with the Yale School of Medicine, called Inspire “a major advance” in sleep apnea treatments for some patients who can’t use CPAP therapy. Left untreated, moderate to severe obstructive sleep apnea can lead to heart disease, accidents and death. — Meg Bryant

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