Inspire Medical Systems announced that the FDA has approved Inspire Upper Airway Stimulation therapy for use in patients with moderate-to-severe obstructive sleep apnea (OSA) who are unable to use continuous positive airway pressure (CPAP).

Inspire therapy is a fully implanted neurostimulation device that provides an alternative option to current treatments for OSA: CPAP, weight loss, oral appliances, anatomy altering surgeries. Inspire therapy consists of a small generator, a sensing lead, and a stimulation lead. The device senses breathing patterns and mildly stimulates key airway muscles to keep the airway open during sleep.

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Patients (n=126) that participated in the STAR (Stimulation Therapy for Apnea Reduction) clinical trial experienced a 68% reduction in apnea events, a 70% reduction in oxygen desaturation events, and significant improvements in daytime functioning as measured by two validated questionnaires.

Inspire therapy does not require removal or permanent change of a patient’s facial or airway anatomy. It will be available to patients in the 2nd half of 2014.

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