FDA Approves NEW Non-Invasive, Long-Lasting Treatment for Underarm Sweating
The U.S. Food and Drug Administration recently announced approval of a completely new type of treatment for axillary hyperhidrosis (underarm excessive sweating) � the first novel treatment option approved by the governing body in nearly 7 years!
Called miraDry, the new treatment uses a non-invasive handheld device to deliver electromagnetic energy to the area beneath the underarm skin where the sweat glands reside, resulting in thermolysis (decomposition by heat) of the sweat glands. The effect can be seen almost immediately and results have been shown to be long-lasting after just two physician visits. In fact, in a clinical study following 120 patients, 70% of miraDry recipients said their sweating no longer bothered them after 1.5 years. miraDry has been developed by Miramar Labs of Sunnyvale, California, and is expected to be available to patients (through trained physicians) by the end of 2011.
While miraDry is the first use of electromagnetic energy to combat excessive sweating, the technology has been safely used in other areas of medicine for years including cardiology, cosmetics, general surgery, urology, and oncology. Outpatient physician visits typically take one hour during which a physician will administer local anesthesia (usually lidocaine injections) and then use the miraDry handheld device to deliver electromagnetic energy to the underarms. The miraDry device cools the outer layer of the skin (dermis) and patients usually experience no discomfort during the procedure. Physician visits are typically scheduled three months apart.
Common side effects include mild to moderate swelling in the armpits that may last a week or two but does not interfere with daily life and, rarely, minor skin irritation (bumps) lasting, at most, a month. While sweating is an essential body function for temperature-control, the underarms house less than 2% of the body�s sweat glands. The elimination of these sweat glands has no effect on body thermoregulation and compensatory sweating (sweating on other body parts, common after ETS surgery) has not shown itself to be a concern with miraDry.
�Prior to the miraDry procedure, there were limited options available for treating axillary hyperhidrosis, none of which offered a lasting, non-invasive solution. While temporary, non-invasive solutions and local surgery have been available, miraDry provides my patients with the opportunity for a truly lasting solution in a non-invasive office procedure,� said Dr. William P. Coleman III in a Miramar press release. Coleman is Clinical Professor of Dermatology and Adjunct Professor of Surgery at Tulane University Health Sciences Center, Founder of Coleman Cosmetic Dermatologic Surgery Center in Metairie, Louisiana, and Past-President of the American Society for Dermatologic Surgery.
As mentioned above, miraDry was recently approved by the FDA. Physician training and commercialization is in process and select physicians across the country will be the first to get the chance to try miraDry in their practices in the next few months. Stay tuned to this newsletter for more information about when miraDry will become available and how you can be among the first to receive treatment with miraDry.
Physicians may learn more about this promising new technology at the International Hyperhidrosis Society�s continuing medical education (CME) events in Denver, Colorado on April 30, 2011 and St. Louis, Missouri on September 24, 2011. Interested physicians should register today.