New Implant OK’d for Obstructive Sleep Apnea

New Implant OK'd for Obstructive Sleep Apnea
New Implant OK’d for Obstructive Sleep Apnea
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 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.

For more information call (800) 230-9807 or visit InspireSleep.com.