17 September 2010-Zeltiq Coolsculpting Cryolipolysis received clearance from the US Food and Drug Administration (FDA) for the non-invasive reduction of fat. Clearance from FDA further validates the effectiveness of this revolutionary treatment, which has already been cleared in Canada and the European Union. Developed in the United States by Zeltiq, a global medical device company, Coolsculpting is a patented non-invasive cooling procedure that gently and effecitvely reduces fat bulges in targeted areas of the body without needles, incisions, pain medication or recovery time.
“We are very pleased the FDA has joined other countries around the world in validating our patented cooling technology for fat reduction that is safe, non-invasive and extremely effective,” said Gordie Nye, President and CEO of Zeltiq. “…we look forward to helping even more doctors and patients discover the benefits of Coolsculpting.”
Developed at a teaching affiliate of Harvard Medical School in the United States, the Coolsculpting breakthrough is based on extensive scientific research that demonstrates that fat cells are more susceptible to extreme cold and are selectively and permanently destroyed. This process is known as Cryolipolysis (cold lipolysis). After the procedure, cooled fat cells begin a process called apoptosis (natural cell death) and begin to shrink and disappear. Based on histological and ultrasound assessment, an average fat layer reduction of 20% was demonstrated at two months after only one procedure.
Founded in 2005, Zeltiq is a global medical device company that developed its patented, non-invasive, clinically proven procedure to selectively reduce fat. The initial Cryolipolysis research and patents originated at the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, a teaching affiliate of Harvard Medical School by Dr Dieter Manstein and Dr R Rox Anderson. Zeltiq has exclusive rights to this innovative, “cool” approach to permanently removing fat. Coolsculpting is cleared in the United States, Health Canada and the European Union, and other international markets, for non-invasive fat layer reduction. Patients are encouraged to visit www.coolsculpting.com to receive additional information and announcements about Coolsculpting by Zeltiq.