FDA Clears First Device-Based Product to Treat Restless Leg Syndrome

The U.S. Food and Drug Administration (FDA) has cleared the first non-pharmacological approach for the condition known as restless leg syndrome (RLS).

The agency OKd the Relaxis system from San Clemente, Calif.-based Sensory Medical Inc.

According to the National Institute of Neurological Disorders and Stroke (NINDS), an estimated 12 million Americans may suffer from RLS, a life-long neurological condition that causes discomfort, pain and sleep deprivation. RLS symptoms occur primarily while a person is resting, and may increase in severity during the night. Many patients find their only relief comes from physical movement, which causes sleep interruption and subsequently leads to physical fatigue, impaired mental functioning, and emotional stress.

“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,” said Fred Burbank, M.D., Sensory Medical’s CEO and an RLS sufferer.

Adults and children may be affected by RLS, according to company data, and the condition is twice as prevalent in women. Among the most impacted are people middle-aged or older, as symptoms tend to increase in frequency and duration with age.

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, the company claims.

“Relaxis represents the first prescription, noninvasive, non-medication alternative for improving quality of sleep in patients with primary Restless Leg Syndrome, a significant health problem that affects millions of people each year. Until now, patients’ only options were to suffer unaided through their condition, or face the potential side effects of long-term medication therapy,” said Burbank.

He added that the total RLS patient population may be considerably underestimated, as NINDS reports some individuals avoid seeking medical attention because they do not believe their condition is treatable, and the condition may be misdiagnosed as insomnia, stress, arthritis, muscle cramps, or attributed to the “normal effects” of aging.

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 counter-stimulation, gradually ramping down and shutting off without waking the patient.

Results 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 RLS, according to Sensory Medical.