Med Device Monday: Restless Leg Relaxer

In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 

Restless Leg Syndrome (RLS) is a neurological sensorimotor condition that affects around 1 in 10 Americans. Also known as Willis-Ekbom Disease, symptoms largely include an uncontrollable urge to move the legs, which can disrupt sleep for sufferers. 

According to the National Sleep Foundation, the disorder is "characterized by an overwhelming urge to move the legs when they are at rest. The urge to move the legs is usually, but not always, accompanied by unpleasant sensations. It is less common but possible to have RLS symptoms in the arms, face, torso, and genital region. RLS symptoms occur during inactivity and they are temporarily relieved by movement or pressure. Symptoms of RLS are most severe in the evening and nighttime hours and can profoundly disrupt a patient's sleep and daily life."

There is no cure for RLS, but thanks to Relaxis, there is now a non-medical treatment that eases discomfort and helps patients sleep. According to the Relaxis website (formerly Symphony, as you will see in the FDA clearance docs), their founder suffers from RLS: "He found relief from his RLS symptoms by getting out of bed, standing and walking. Although his symptoms were gone, the physical act of standing or walking left him wide awake. Dr. Burbank postulated that a device providing counterstimulation, while in bed, would relieve his symptoms and allow him to quickly return to sleep. As a result, our team developed a series of test devices and found that these devices allowed him to remain in bed while relieving his symptoms." They go on to explain that Relaxis is a "Vibratory counter-stimulation device. A vibratory counter-stimulation device is a prescription device that provides electrically powered mechanical vibration to improve the quality of sleep in patients with primary Restless Legs Syndrome." 

Sleep deprivation isn't just tiring: it can be life-threatening. Chronic sleep deprivation can lead to accidents & injury, obesity, heart disease, depression, suicide, kidney disease, diabetes, stroke, and more. (Also discussed this in a previous post about an insomnia device.) Any device that provides relief to patients and leads to more and improved sleep is certainly a win.

This video is a bit dry, but it explains how Relaxis works. It's set up to cycle through a 30-minute operating schedule, then 5 minutes of tapering down, but you can re-run it as often as needed. Intensity and length of session can easily be monitored with a hand-held controller. The idea is to place the pad under the area that you have the biggest RLS flare-up, and it provides stimulation to the area which quells the urge to get up and alleviate the discomfort, allowing the patient to get back to sleep.

Further reading:

1. Relaxis/Symphony Classification Order

2. Relaxis/Symphony Decision Summary