Relaxis™ For RLS Patients
Relaxis is expected to be released in October 2014. For the latest updates on Relaxis connect with us on Facebook and Twitter
Improve Sleep with Relaxis
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 Relaxis
During a nighttime RLS attack, patients can place and activate the Relaxis 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!
To learn more about the counterstimulation provided by Relaxis, click on the link here.
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.
INDICATIONS FOR USE:
The purpose of the Relaxis™ device is to improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS) through the use of vibratory counterstimulation.
This device should not be used by patients who have been diagnosed with deep venous thrombosis (DVT) in either leg during the last 6 months because of the known potential to dislodge or break up the clot.
For prescription use only.
WARNINGS & CAUTIONS:
- Relaxis is only intended for use by patients with primary Restless Legs Syndrome (RLS). It is not intended for use by people who have:
- Leg skin disorders such as eczema, psoriasis, cellulitis, non-healing wounds; or
- Secondary RLS.
- Contact 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.
- Relaxis has not been tested on people who take drugs that may cause RLS or RLS symptoms. Safety and effectiveness have not been established in these people.
- Only apply Relaxis to normal, intact, clean, healthy skin.
- The Relaxis pad and controller will become warmer during use. Stop use of Relaxis if the heat causes discomfort or pain.
- Relaxis consists of cotton (outer pad cover), polyvinyl chloride (inner pad cover), polyurethane foam (internal pad), acrylonitrile butadiene styrene and polyester plastic (controller). People with known allergic reactions to these materials should not use Relaxis. If a skin reaction occurs after you use Relaxis, contact your doctor.
- Stop using Relaxis and contact your doctor if your RLS symptoms worsen.
- Do not initiate more than two back-to-back 35-minute therapy cycles.
- Only apply Relaxis as needed. Too much stimulation may lead to discomfort.
- Do not use Relaxis in moist, wet, or dusty areas. This may increase the risk of electrical shock and failure.
- Do not use your Relaxis in oxygen rich areas.