The U.S. Food and Drug Administration has approved the first fully implantable neurostimulator as a treatment for obstructive sleep apnea, according to a news release by Minneapolis-based Inspire Medical Systems, the manufacturer of the device.
The neurostimulator, Inspire Upper Airway Stimulation therapy, is approved for patients who cannot use continuous positive airway pressure as a treatment, the current standard of care for sleep apnea, according to the news release.
The Inspire Upper Airway Stimulation therapy senses breathing patterns and delivers mild stimulation to certain airway muscles, keeping them open during sleep, according to the news release. Patients turn it on and off with a remote.
In a clinical trial, participants who received the Inspire therapy implant experienced a 78 percent reduction in apnea events, a 70 percent reduction in oxygen desaturation events and self-reported improved daytime functioning, according to the news release.
The Inspire Upper Airway Stimulation therapy will be commercially available to U.S. patients in the second half of 2014, according to the news release.
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