FDA clears device for restless legs syndrome

Relaxis device for RLS--Courtesy Sensory Medical

The FDA gave 510(k) clearance to the first nonpharmacological approach to helping restless legs syndrome patients get better sleep, Sensory Medical said in a May 29 statement.

"Relaxis represents the first prescription, noninvasive, non-medication alternative for improving quality of sleep in patients with primary restless legs syndrome, a significant health problem that affects millions of people each year," CEO--and RLS sufferer--Dr. Fred Burbank said in a statement.

When faced with an episode of RLS, the patient puts her leg on the Relaxis pad and chooses the appropriate setting. The vibration lasts for 30 minutes. Sensory Medical says the device is preferable to medications for RLS, which lose effectiveness with time, can be addictive and should not be given to pregnant women and dialysis patients.

Sensory Medical says the federal National Institute of Neurological Disorders and Stroke estimates that 12 million Americans may have RLS. It occurs twice as often in women. Symptoms include discomfort, pain and sleep deprivation. Burbank believes that the actual number of RLS patients may be higher because some patients don't seek treatment and others may be misdiagnosed.

"Until now, patients' only options were to suffer unaided through their condition, or face the potential side effects of long-term medication therapy," said Dr. Burbank in the statement.

- read the release

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