The United States Patent and Trademark Office has issued U.S. Patent 9,017,273 to Sensory NeuroStimulation Inc covering the technologies used in Relaxis, a vibratory medical device that helps improve the quality of sleep in patients with primary restless legs syndrome (RLS).
The patent, entitled “Devices and Methods for Treating Restless Leg Syndrome,” claims an exemplary system for generating a counter-stimulation in a patient suffering from RLS and includes a device configured and arranged to generate a counter-stimulation of an amplitude, intensity, and time duration sufficient to relieve RLS. These patent rights are assigned to and wholly owned by Sensory NeuroStimulation Inc. The patent will expire in 2035.
Relaxis is the first and only medical device cleared by the FDA for improving the quality of sleep for patients with primary RLS. It is available by prescription only.
“The proprietary Relaxis pad provides vibratory counterstimulation through unique vibratory frequencies and is the only technology that was specifically designed to address the symptoms of restless legs syndrome,” says Fred Burbank, MD, CEO of Sensory NeuroStimulation, Relaxis’ inventor and former RLS sufferer, in a release.
The results of two prospective, double-blinded, randomized, controlled, multi-center clinical trials validated the ability of this technology to improve the quality of sleep in patients with primary RLS. During an RLS episode, the patient places the low-profile Relaxis pad at the site of their discomfort and chooses a vibration intensity that is pleasant and strong enough to displace the unpleasant sensations of RLS. The device provides 30 minutes of vibratory counterstimulation, gradually ramping down and shutting off without waking the patient. The soothing vibratory counterstimulation provides relief that is similar to what patients get from massaging their legs.