The FDA last week greenlighted Sensory Medical’s vibrating Relaxis pad for the treatment of patients with primary restless leg syndrome — the first nonpharmacological approach for the painful neurological disorder, which affects about 12  million Americans.

To treat an RLS episode, patients place the low-profile Relaxis pad at the site of discomfort and select a vibration intensity. The device, which can be used in bed, provides 30 minutes of counterstimulation, gradually ramping down intensity and shutting off without waking the patient, the San Clemente, Calif., company says.

RLS symptoms occur primarily while a person is resting, and many patients find their only relief comes from physical movement, which causes sleep interruption and may lead to physical fatigue, impaired mental functioning and emotional stress, according to the National Institute for Neurological Disorders and Stroke.

Medication, including dopaminergic agents used to treat Parkinson’s disease, anticonvulsants, narcotic opioids, muscle relaxants and sleep medications, have been the standard care for RLS. But they pose risks of dependency and, in some cases, may worsen RLS symptoms over time, Sensory Medical says.

The market for RLS treatments is hard to quantify due to there being few RLS-specific drugs, but Sensory Medical spokeswoman Laura Min Jackson estimates it is at least $1 billion for on-label prescriptions.

With U.S. marketing clearance in hand, thecompany is pursuing a CE Mark this year, Jackson says. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.