US-based medical device company Sensory Medical has received approval from the US Food and Drug Administration (FDA) for its Relaxis device, designed to provide physical relief for Restless Leg Syndrome while enabling the patient to remain in bed.
Sensory Medical claims that the low-profile Relaxis is the first non-pharmacological approach to help improve the quality of sleep in patients with primary Restless Leg Syndrome.
Sensory Medical CEO Fred Burbank said that Relaxis represents the first prescription, noninvasive, non-medication alternative for improving quality of sleep in patients with primary Restless Leg Syndrome.
The Relaxis pad, which is placed at the site of patient’s discomfort during Restless Leg Syndrome episode, provides 30 minutes of vibratory counterstimulation, gradually ramping down and shutting off without waking the patient.
Data from two randomized, multi-center, 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 Restless Leg Syndrome.
Sensory Medical’s Relaxis system will be available on a prescription-only basis in the US starting in the third quarter of 2014.