FDA regulators this week cleared the 1st non-drug therapy for restless leg syndrome, Sensory Medical’s Relaxis system.
The Relaxis device uses vibration to ease discomfort associated with RLS, a condition usually treated with drugs such as anti-convulsants, narcotic opioids and muscle relaxants. Sensory Medical CEO Dr. Fred Burbank, an "RLS sufferer" himself, touted the device’s non-pharmacological approach to treatment.
"Until now, patients’ only options were to suffer unaided through their condition, or face the potential side effects of long-term medication therapy," Burbank said in prepared remarks.
The technology resembles a bad and is designed for patients to use in bed, applying vibration to the affected area in order to disrupt symptoms of RLS. Relaxis provides 30 minutes of "vibratory counterstimulation" and gradually phases out to shut off without waking the patient.
Sensory Medical won FDA clearance based on positive results from randomized, multi-center, controlled, double-blinded, prospective trials encompassing nearly 160 patients with primary RLS, the company said.