FDA OK’s Trial for Inspire Medical’s Implantable Nerve Stimulator for Sleep Apnea

Obstructive Sleep Apnea (OSA) is a growing problem as our nation’s BMI steadily increases. The sequelae (hypertension, daytime sleepiness, etc.) put a burden on patients, employers, and the health care system as a whole. The traditional treatment, a CPAP device, is effective, but somewhere around half of patients are unable to tolerate sleeping with a mask on their face.
Inspire Medical developed a technique they call Upper Airway Stimulation (UAS), which consists of a pulmonary pressure sensor implanted in the chest, a pulse generator that looks very similar to a pacemaker, and a lead that is implanted close to the hypoglossal nerve. The idea is that when the pulmonary pressures indicate the patient’s intent to breathe, the hypoglossal nerve will be stimulated, thus causing the involved muscles to maintain an open airway during inspiration and hopefully avoid apneic periods and nighttime desaturations.
We reported on this device back in February, 2009 when Inspire implanted it in their first patient, but now the company is cleared to start a multi-center investigation called the STAR trial (Stimulation Therapy for Apnea Reduction) in the U.S. and Europe. Patient enrollment is expected to start in January 2011.
Press release: Inspire Medical Systems Announces FDA approval for Pivotal Clinical Trial…
Link: Inspire Medical…