The US Food and Drug Administration (FDA) has granted commercial clearance for Relaxis, a non-pharmacological approach to help improve the quality of sleep in patients with primary restless leg syndrome (RLS). The device was created by Sensory Medical Inc, headquartered in San Clemente, Calif.

“Our company was founded solely to find new alternatives for treating RLS, and we are pleased to be the first and only company to have a non-pharmacological approach, clinically proven and FDA cleared, to improve sleep by addressing symptoms of this devastating condition,” says Fred Burbank, MD, Sensory Medical’s CEO and an RLS sufferer himself, in a release.

To alleviate RLS symptoms, medication therapy is often prescribed, including dopaminergic agents used to treat Parkinson’s disease, anti-convulsants, narcotic opioids, and muscle relaxants and sleep medications such as benzodiazepines. Unfortunately, some of these medications present the risk of dependence or addiction, and are considered inappropriate for certain RLS sufferers, including pregnant women and dialysis patients. NINDS reports that some drugs also have been found to actually worsen patients’ RLS symptoms over time, despite initially providing relief.

How Relaxis Works

The Relaxis device was designed to provide physical relief of RLS while enabling the patient to remain in bed. During an RLS episode, the patient places the low-profile Relaxis pad at the site of their discomfort and chooses a vibration intensity. The device provides 30 minutes of vibratory counterstimulation, gradually ramping down and shutting off without waking the patient.

Results from two randomized, multicenter, controlled, double-blinded, prospective clinical research studies published in a peer-reviewed journal article indicated that the Relaxis device was found superior to placebo pads for improving sleep quality in patients with primary RLS.

Sensory Medical Inc will be exhibiting the new Relaxis system in booth #1018 at SLEEP 2014 beginning June 2 at the Minneapolis Convention Center. It will be available on a prescription-only basis in the United States starting in the third quarter of 2014.