Erchonia’s Body Contouring Clinical Trial Published in Lasers in Surgery and Medicine
Erchonia, the leading developer of non-invasive, low level laser healthcare applications, announces today the results of its body contouring clinical trial are being published in Lasers in Surgery and Medicine’s January issue.
Lasers in Surgery and Medicine, the most widely-circulated, peer-reviewed scientific journal dedicated to laser therapy and diagnosis, is publishing the complete results of Erchonia’s recent, double blind, randomized, multi-site and placebo-controlled study. The study revealed that in six treatments with Erchonia’s Zerona laser – without surgery, diet restrictions or any other adjuncts – patients lost an average of 3.65 inches from their waists, hips and thighs.
Results using the Erchonia laser also have been recently published in the Plastic and Reconstructive Surgery, The Aesthetic Surgery Journal, The American Academy of Cosmetic Surgery Journal, and Clinics in Plastic Surgery and Liposuction.
“With this study, Erchonia has set the standard for non-invasive body contouring devices,” comments Steve Shanks, president of Erchonia. “We have been researching the Erchonia laser’s effect on fat cells for about 12 years. This inclusion in the world’s most prestigious laser journal ads even more credibility to our proven science.”
In contrast to high-power, high-heat lasers that are used in various surgical procedures, Erchonia lasers produce a low-level, or cold, output that has no thermal effect on the body’s tissue. Instead, the non-invasive laser helps the body absorb fat by stimulating biological function. As fat congregates in interstitial spaces of cells for a certain amount of time, the Erchonia laser stimulates the body to rid itself of that excess fat using the body’s normal processes.
About the clinical trial: Placebo patients were treated with a 635nm L.E.D. The test group was treated with the Erchonia’s Zerona laser. All patients were treated six times over two weeks, for twenty minutes on each side of the body (forty minutes total). Patients were instructed not to restrict their diets. Patients did not feel pain during the non-invasive treatment, did not receive anesthesia, and assumed normal activities after each treatment.
Erchonia pre-submitted the study results to the FDA for comments and set the clinical significance as a reduction of a minimum of 3 inches cumulative of the waist, hips and thighs. The FDA wanted to distinguish between statistically significant and clinically meaningful results which it felt would help with consumer confidence. Erchonia also submitted a 20-patient study on lipid panel reductions during this treatment as a safety measurement. The results of this study will be published at a later date.
The article published in Lasers in Surgery and Medicine represents all of the data that Erchonia submitted to the FDA for market clearance or 510k which Erchonia expects is imminent.
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research & development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven to be safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, accelerate healing, and treat acne. For additional information, visit www.erchonia.com