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FDA approves implantable tongue stimulator for apnea.

An implantable device that stimulates the hypoglossal nerve during inspiration has been approved for a subgroup of adults with moderate to severe obstructive sleep apnea, the Food and Drug Administration has announced.

According to an FDA statement, the device is indicated for adults aged 22 years and older with moderate to severe OSA "who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments," such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BPAP) machines, "and who do not have a complete concentric collapse (as seen during drug induced sleep endoscopy) at the soft palate level."

The device comprises a stimulation lead placed around the distal hypoglossal nerve, a pulse generator implanted subcutaneously below the clavicle in the upper chest, and a respiration-sensing lead inserted between the fourth and fifth ribs--implanted under general anesthesia. The pulse generator "detects the patient's breathing pattern and maintains an open airway with mild stimulation of the hypoglossal nerve, which controls tongue movement, during inhaled breathing," the FDA noted. The stimulation settings are adjusted by physicians with an external programmer, and patients use a remote to turn the device on (before sleeping) and off (when awake).

The FDA's Anesthesiology and Respiratory Therapy Devices Panel backed approval of the Inspire Upper Airway Stimulation System based on results of the pivotal STAR (Stimulation Therapy for Apnea Reduction) trial of 126 patients with moderate to severe OSA. Treatment, which delivered unilateral stimulation of the hypoglossal nerve, "synchronous with ventilation, resulted in significant and clinically meaningful reductions in the severity of sleep apnea and self-reported sleepiness and improvement in quality of life measures at 1 year" (N. Engl. J. Med. 2014;370:139-49).

The device, approved on May 1, will be available later this year, according to the manufacturer, Inspire Medical Systems.

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Author:Mechcatie, Elizabeth
Publication:Family Practice News
Geographic Code:1USA
Date:Jun 15, 2014
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