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FDA Approves Novel Implantable Device for Sleep Apnea — Physician’s First Watch
FDA Approves Novel Implantable Device for Sleep Apnea
By Kristin J. Kelley
The FDA has approved a new treatment — Inspire Upper Airway Stimulation therapy — for patients with moderate-to-severe obstructive sleep apnea who cannot use a continuous positive airway pressure machine.
The device is implanted in the upper chest, senses breathing patterns, and mildly stimulates the airway muscles, keeping the airway open. The device is turned on and off using a handheld remote.
In a study published in the New England Journal of Medicine, some 125 patients (83% men, mean age: 55 years) had the device implanted. At 12 months, the number of apnea events per hour decreased by 68% and oxygen desaturation events decreased by 70%.
The procedure to implant the device has a shorter recovery time than surgery to alter airway or facial anatomy, according to the manufacturer. It is expected to be available to patients by the end of 2014.