SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Relaxis, the innovative, FDA-cleared, non-drug approach to treating Restless Legs Syndrome (RLS), has been used to help a majority of RLS patients avoid general anesthesia during cataract surgery, according to a new article published in the September 2016 issue of Outpatient Surgery Magazine.
The article, published by Dr. Anthony Mannarino of Langhorne, PA., reports that a growing number of RLS patients had been requiring general rather than the preferred local anesthesia during their surgical procedures. However, once the Relaxis pad was placed under RLS patients’ calves and the therapeutic vibrations were adjusted to counteract their RLS symptoms, Dr. Mannarino was able to safely perform cataract surgery under local anesthesia 93% of the time, with only one case out of 15 total requiring conversion to general anesthesia.
In his article, Dr. Mannarino concludes that “the results from our recent Relaxis trial were impressive.” Relaxis is the only FDA-cleared medical treatment evaluated under prospective clinical trials, which has been found to help relieve symptoms and improve sleep in patients with primary RLS.
Cataract Surgery, RLS Both Progressive, Age-Related Conditions
“We find the results of Dr. Mannarino’s work encouraging, because both RLS and the cataracts are progressive, age-related medical conditions,” said Fred Burbank, M.D., president of Sensory NeuroStimulation Inc., which makes Relaxis.
Each year, about 3.6 million of the 24.5 Americans with cataracts undergo surgery to replace their affected intraocular lens (IOL). According to the American Academy of Ophthalmology, the risk of developing cataracts increases with age; an estimated half of all Americans are projected to develop cataracts by the age of 75. In addition, more than 50 million people are expected to have the condition by the year 2050. Worldwide, the World Health Organization estimates that 32 million cataract surgeries will be performed by 2020, placing the global IOL market value at more than US$4.7 billion.
The National Institute of Neurological Disorders and Stroke (NINDS) estimates that as many as 12 million Americans may be suffering from RLS, a life-long neurological condition in which a person may regularly experience uncomfortable, uncontrollable tingling, aching, and pain in their legs. RLS is a progressive disease and often worsens as patients age. The symptoms typically begin while at rest; in severe cases, attacks may occur repeatedly and with increased severity during the night. Repeated sleep interruptions from RLS can reduce a patient’s quality of life, leading to physical fatigue, reduced mental functioning, and emotional stress.
“The U.S. FDA has already validated the importance of Relaxis as a therapeutic option for RLS patients, and Dr. Mannarino’s experience, while a relatively small sample and not part of an official clinical trial or current device indication, is promising based on its potential as a solution for the millions of people who have RLS and also may require cataract surgery,” Dr. Burbank said.
Relaxis: A New, Drug-Free Solution for Millions of RLS Sufferers
Dr. Burbank, a physician and former RLS patient himself, invented Relaxis after finding no other acceptable alternatives to the expense and potential side effects associated with the medications typically prescribed to treat RLS. Medications typically prescribed for RLS include psychotropic drugs and potentially-addictive opioid pain-killers, but many patients report having to regularly increase their dosages, the number of medications, and the frequency at which they take them, while failing to achieve sustained relief from their RLS symptoms.
In randomized, prospective clinical studies, Relaxis was proven to improve the quality of sleep in people with primary RLS. Subsequent articles in published medical journal articles indicate that Relaxis provides RLS patients with the same sleep improvement as medications, but without the drugs’ risk of potentially severe side effects.
Relaxis is available by prescription only, so patients must first talk with their doctor and request a prescription before receiving the device. Sensory NeuroStimulation Inc., which makes Relaxis, offers patients a no-risk, 30-day trial so patients can determine how well Relaxis works for them. Additional information is available by visiting www.myrelaxis.com or calling toll-free at (888) 475-7435.
About Sensory NeuroStimulation Inc.
Based in San Clemente, Calif., the privately held Sensory NeuroStimulation Inc. was formed in 2009 after the company’s CEO, Fred Burbank, M.D., began experiencing RLS and sought a non-medication solution to relieving the condition’s symptoms. Sensory NeuroStimulation assembles RelaxisTM, the first FDA-approved non-drug medical device evaluated under clinical trial, which can improve the quality of sleep in patients with primary Restless Legs Syndrome (RLS). Additional information about the company and its technologies is available at www.MyRelaxis.com.