Inspire Medical’s Pivotal Clinical Trial Gets FDA Approval For Treatment of Obstructive Sleep Apnea

Inspire Medical Systems, a developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea or OSA Tuesday said that the company has received approval from the U.S. Food and Drug Administration or FDA to begin its STAR pivotal clinical trial.

Inspire was formed in 2007 when the technology and a significant intellectual property portfolio was spun-out of Medtronic.

OSA is a common sleep disorder that occurs when the tongue and other soft tissues of the throat relax and obstruct the airway during sleep.

According to the company, the STAR trial is a multi-center study that will evaluate both the safety and effectiveness of Inspire Upper Airway Stimulation therapy in patients with moderate to severe OSA . The results of this study will be the basis for a Pre-market approval or PMA application to the FDA.

Inspire also said that it has received CE Mark for Inspire Upper Airway Stimulation therapy.

Tagged with: Airway • FDA Approval • Inspire Medical Systems • Sleep Apnea Disorder • sleep disorder • slep apnea • Treatment of Obstructive Sleep Apnea • Treatment of OSA • Upper Airway Stimulation therapy

Filed under: Obstructive Sleep Apnea • Sleep • Sleep Apnea Treatment • Sleep Disorders

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