ZELTIQ RECEIVES FDA CLEARANCE FOR PATENTED, NON-INVASIVE COOLING TREATMENT FOR FAT REDUCTION “CoolSculpting”
Great news for men and women dealing with one of the most exercise and diet-resistant problem areas: “love handles.” CoolSculpting also known as Cryolipolysis has been cleared by the U.S. Food and Drug Administration (FDA) for the non-invasive reduction of fat. The procedure delivers a non-invasive, safe, and clinically proven method for the selective reduction of bulges from small amounts of excess fat in the body.
TriBeCa Plastic Surgery has been using CoolSculpting in their office for over two years now and Dr. Coleman was involved in the original FDA study. Dr. Coleman is the lead author of the clinical study that examined the efficacy and safety of the exciting new technology for non-invasive reduction of fat. The fat reduction initially observed in the published paper appears to be maintained. A preview of the article authored by Dr. Coleman can be viewed as a pdf from the journal of Aesthetic Plastic Surgery. Or the article can be seen in full by accessing the Journal of Aesthetic Plastic Surgery. For a review of the paper check out Aesthetic Device Review.
Cryolipolysis is a non-invasive procedure for people who are not overweight, but despite diet and exercise, have bulges of fat that bother them. While traditional liposuction and laser liposuction are invasive surgical procedures that are designed for fat reduction, CoolSculpting is an exciting new approach that is non-invasive and has shown significant, durable, and reliable results in clinical studies for removing fat without the potential risks and downtime of invasive procedures.
CoolSculpting fills a previously unmet need in the medical aesthetic marketplace with a safe procedure cleared by the FDA that gently cools unwanted fat cells in the body to induce a natural, controlled elimination of fat cells. This reduces bulges in the treated area of the body. On average, each CoolSculpting procedure results in a 20% or more reduction of fat in the treated area. Patients can start to see results as soon as three weeks following treatment, with the most dramatic results occurring over a period of two to four months in most patients.
Unlike most other methods of fat reduction, CoolSculpting involves no needles, surgery or downtime. During the procedure, Dr. Coleman’s staff applies a non-invasive applicator that delivers precisely controlled cooling to the treatment area to specifically target underlying fat, leaving surface skin tissue unaffected. Procedures last about one to two hours, but some patients opt for more treatments lasting up to four to six hours the same day. Patients can have additional procedures for more pronounced effects if they desire.
Developed at Massachusetts General Hospital in Boston, the CoolSculpting breakthrough is based on extensive scientific research that demonstrates that your body’s fat cells are more susceptible to cold applied through your skin. The targeted fat cells are selectively, painlessly, and permanently destroyed. This process is known as Cryolipolysis (cold lipolysis). Starting several weeks after the procedure, cooled fat cells begin a process called apoptosis (natural cell death) and begin to shrink and disappear. Comprehensive multi-center clinical studies submitted to the FDA validated that CoolSculpting kills fat cells in the area treated based on histological and ultrasound assessment.
CoolSculpting by Zeltiq is not intended as a weight-reduction program for overweight individuals. The best candidates for the CoolSculpting procedure are people near their ideal body weight who eat well and exercise regularly and have pockets of fat that have not responded to a healthy lifestyle. They are seeking long-lasting spot reduction for this specific area of fat, but they are not considering a surgical procedure with its inherent expense, downtime, and safety risks.
CoolSculpting™ is now cleared in the United States, Canada, the European Union, and other international markets for non-invasive fat layer reduction.
The CoolSculpting procedure by Zeltiq has been available at TriBeCa Plastic Surgery since early 2008 when the FDA study began.
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