Sensory Medical announced that the FDA has granted commercial clearance for Relaxis, the first nonpharmacological medical device to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS).

Relaxis is a prescription-only device that uses vibratory counterstimulation via the Relaxis pad. The device is placed at the site of patient leg discomfort and provides 30 minutes of vibratory counterstimulation that gradually decreases in intensity and turns off without waking the patient.

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The FDA clearance is based on results from two randomized, multi-center, controlled, double-blinded, prospective clinical research studies in which the Relaxis device was found superior to placebo pads for improving sleep quality in patients with primary RLS.

Relaxis will be available by prescription starting in the 3rd quarter of 2014.

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