The Relaxis™ Device For RLS Patients
The Relaxis™ device is expected to be released in September 2014. For the latest updates on Relaxis™ connect with us on Facebook and Twitter
Improve Sleep with the Relaxis™ Device
For patients with RLS, getting a good night’s sleep is a challenge. Between interruption of sleep and having to get out of bed to make your RLS symptoms go away, restful sleep can seem like it’s only a dream. While drugs have been developed and provide some relief from RLS symptoms, not all patients are comfortable with, or able to take, additional medications. For some patients, the side effects of RLS drugs and the cost of monthly prescriptions can be prohibitive.
Sensory Medical’s Relaxis™ is an FDA-cleared device that uses specific vibrations to disrupt RLS symptoms in the comfort of your own bed, when needed. There’s no need to get out of bed once, or worse, several times a night, to make the symptoms go away. With Relaxis™ you can lay in bed with the pad under the affected area and experience relief of RLS symptoms.
“First In Class”
The original use of vibration for the relief of pain and discomfort was first proven in 1964. Now, that technique coupled with years of medical device research and development to relieve RLS symptoms have come together for a prescription-based treatment for your RLS symptoms. In fact, the Relaxis™ device is the first prescription device cleared by the FDA to treat RLS symptoms. The Relaxis™ device is a “First In Class” device, which means it’s the very first non-drug treatment for the symptoms of RLS. The Relaxis™ device has been clinically studied and reviewed by the FDA to improve the quality of sleep in patients with primary RLS. The Relaxis™ device requires a prescription, and only your doctor can determine if the Relaxis™ device is appropriate for your RLS symptoms.
Although patients can relieve some of their symptoms through movement, “movement” requires that patients get up from bed and move about. By the time patients relieve their pain and return to bed, they often feel “awake.” Falling back to sleep can be difficult, especially if a patient experiences another RLS episode while trying a second or even third time to go back to sleep. The Relaxis™ device is designed so that patients can easily address their RLS symptoms while remaining in bed, lying down. It is intended to eliminate the need to get up and move about so that patients can return quickly and easily to a restful sleep.
Please contact Sensory Medical, Inc. for additional information.
How to Use the Relaxis™ Device
During a nighttime RLS attack, patients can place and activate the Relaxis™ pad under their legs in the location where they experience the greatest degree of discomfort, usually under the calf or thigh. Part of the smart design of the the Relaxis™ device engineering is its automatic shut off and ramp down feature. The vibration from the pad (a form of counterstimulation) runs for approximately 30 minutes, and then gradually decreases in intensity so you won’t be awakened when it stops. In addition, it’s easy to use. Simply plug it in and turn it on!
What are the potential benefits of using the Relaxis™ device?
The Relaxis™ device may help to improve the overall quality of sleep for individuals with primary RLS. It is not intended to treat RLS or improve any other symptoms of RLS. It may take up to 4 weeks for you to experience an improvement.
The Relaxis™ device was evaluated on men and women diagnosed with primary RLS. During the test, some people received the Relaxis™ device and some people received another device that did not vibrate. The test participants were asked to answers questions about the quality of their sleep at the beginning of the test and after using their device for 4 weeks. The results showed that participants who used the Relaxis™ device were more likely to report less sleep disturbances and better quality sleep than the participants who used the non-vibrating device. The results did not show differences between the two devices for any other RLS symptoms, the patients’ quality of life, or for the patients’ RLS, in general.
What are the potential risks with using the Relaxis™ device?
The Relaxis™ device may cause your RLS symptoms to worsen. It may also cause leg cramping, tingling, soreness, pain, or motion sickness.
The most common problem reported during testing was that RLS symptoms worsened when using the Relaxis™ device. However, this worsening resolved within 3 weeks of stopping use of the device, and the symptoms returned to the same level reported before using the device. There were no long term effects observed. Leg cramping, tingling, soreness, pain, and motion sickness were also reported, but much less frequently. All of these problems resolved on their own without any other treatment.
If your RLS symptoms worsen, stop using the device and contact your doctor.
What are the alternatives to using the Relaxis™ device?
There are other alternatives to treat the symptoms of RLS. The standard way of treating RLS is with drugs. Ask your doctor what treatment may be best for you.
The Relaxis™ device is only intended for use on patients with primary Restless Legs Syndrome (RLS). It is not intended to be used by people who: have leg skin disorders such as eczema, psoriasis, cellulitis, non-healing wounds; or have secondary RLS.
Patients should discontinue use if RLS symptoms worsen.
Apply stimulation only to normal, intact, clean, healthy skin.
Apply stimulation only as necessary and avoid excessive activation of consecutive cycles. Over-stimulation may lead to discomfort at the applied site.
This device in not intended for use in oxygen rich environments. It is intended for use in environments with normal air.
The pad materials include a cotton outer cover, an inner Lycra cover, and an internal polyurethane foam. People with known allergic reactions to these materials should not use this device. If a skin reaction occurs after using the device, please contact your physician.
The user should not initiate more than two back-to-back 35-minute usage cycles since device testing has not been performed to support more than two consecutive usage cycles.
Do not use the system in a moist or wet environment.
Do not spill fluids on the device as it may result in device failure.
Never operate the product if the device or cables are damaged.
Only plug the power supply into a 120VAC outlet.
Do not bend the controller or power cord excessively. This may cause damage.
Never carry the pad by the cord. Never use the power cord to pull the power plug from the wall socket.
Use caution when stepping over or around cables.
Unplug the device before removing the outer cover for cleaning. Remove and wash outer cotton cover as needed per instructions in cleaning section.
Do not remove the inner cover from the pad.
If packaging has been damaged, check to ensure that the Relaxis™ device functions properly.
The Relaxis™ device is available by prescription only. Consult your doctor for a prescription before using the Relaxis™ device as it is intended only for individuals with primary RLS. Consult your doctor if you have secondary RLS caused by iron deficiency anemia, back pain, kidney failure, diabetes, peripheral neuropathy (numbness or tingling in hands or feet), or pregnancy, because the Relaxis™ device has not been tested on people with secondary RLS. The device has not been tested on people who are taking drugs that may cause RLS or RLS symptoms. Safety and effectiveness have not been established in these people.