FDA Clears Freezing Fat for Reduction
Dr. Sydney Coleman of New York City reports that ZELTIQ RECEIVED FDA CLEARANCE FOR PATENTED NON-INVASIVE COOLING TREATMENT FOR FAT REDUCTION
Great news for men and women with exercise and diet-resistant problem areas such as “love handles.” CoolSculpting, a type of cryolipolysis, is now cleared by the U.S. Food and Drug Administration (FDA) for the non-invasive reduction of fat. The procedure delivers a safe, and clinically proven method for the selective reduction of small volumes of excess fat in the body. CoolSculpting had already been cleared for use in the European Union and other international markets. Worldwide, more than 7,000 patients have already been treated.
Cryolipolysis is a non-invasive procedure for persons who are not overweight, but have localized fat deposits despite diet and exercise. While traditional liposuction and laser liposuction are invasive surgical procedures, CoolSculpting is an exciting new approach that is non-invasive. The CoolSculpting device gently cools unwanted fat cells beneath the surface of the skin to induce a natural, controlled elimination of fat cells. Clinical studies have shown significant, durable, and reliable results with the device without the potential risks and downtime of invasive procedures.
Dr. Sydney Reese Coleman has been using the ZELTIQ CoolSculpting device in his office in TriBeCa for over two years now and was involved in the original FDA clinical trials. Dr. Coleman is also the lead author of the clinical study that examined the efficacy and safety of this exciting new technology. The fat reductions initially observed and reported in the published paper appear to be stable. A preview of the article authored by Dr. Coleman can be viewed as a pdf from the journal of Aesthetic Plastic Surgery. The article can be seen in its entirely by accessing the Journal of Aesthetic Plastic Surgery. For a review of the paper, check out Aesthetic Device Review.
On average, the CoolSculpting procedure results in more than a 20% reduction of fat in the treated area, and patients can start to see results as soon as three weeks following treatment, with the more dramatic results occurring over a period of two to four months in most cases.
Unlike most other methods of fat reduction, CoolSculpting involves no needles, surgery or downtime. During the procedure, Dr. Coleman or one of his staff applies a non-invasive applicator to the skin surface of the area to be treated. The applicator delivers precisely controlled cooling to specifically target underlying fat, leaving surface skin tissue unaffected. Treatments last from one to two hours, depending on the size of the area to be treated, and whether there are two “sides” involved. Most patients say they feel a little tugging and a cold sensation for about 5 minutes, but are usually discomfort-free for the remaining 55 minutes of the hour long treatment. Treatments can be done on multiple areas during one session, but each specific area is treated individually. Patients can resume normal activities immediately following treatment. Follow up is usually scheduled for about 8 weeks after treatment to assess the results. If a patient desires further treatment in the same area, he or she can have it done at that time.
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 susceptible to cold applied through your skin. The targeted fat cells are selectively, painlessly, and permanently destroyed. This process is known as Cryolipolysis (cold fat cell destruction). Starting several weeks after the procedure, cooled fat cells begin a process called apoptosis (natural cell death) and begin to shrink and disappear. Data submitted to the FDA from comprehensive multi-center clinical studies validated that CoolSculpting kills fat cells in the area treated based on histological (microscopic) 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 persons near their ideal body weight who eat well and exercise regularly but have pockets of fat that persist. They are seeking long-lasting spot reduction, but are not interested in a surgical procedure with its inherent expense, downtime, and risks.
Dr. Coleman was recently interviewed by CBS News concerning Cryolipolysis. Please go to the CBS website link to watch the video of the news piece and to read the script. Please note, you will need to click on the video located in the upper right hand corner of the page.
Written by the office staff at TriBeCa Plastic Surgery
For background on Zeltiq and Cryolipolysis, please refer to previous postings entitled the following:
- CBS interviewed New York City Surgeon Sydney Coleman for Zeltiq Cryolipolysis
- Freezing Fat for Natural Body Sculpting
- Zeltiq device approved by FDA for Several Uses
- Noninvasive Liposuction Alternative,
- Zeltiq Device Now Available in the Office of Sydney Coleman in New York City, NY.
For a more scientific description, please refer to the following: RESHAPING FAT BY CRYOLIPOLYSIS,
Further Media Coverage:
- Cosmetic Surgery Times: “Results for cryolipolysis impressive”
- American Health & Beauty: Cryolipolysis: Zeltiq Freezes Your Fat Away
Please call TriBeCa Plastic Surgery at 212 571 5200 for more information.
© Coleman 2010