From the Wires
Zeltiq(TM) Aesthetics Announces European CE Mark Approval for Non-Invasive Fat Layer Reduction Using Cryolipolysis(TM)
- Impressive Clinical Results Presented at Major Scientific Meeting of Dermatologists and Plastic Surgeons from Five Continents
By: PR Newswire
Sep. 21, 2009 02:30 AM
The CE Mark approval gives the company the ability to market the Zeltiq
device to countries of the European Union and coincided with the company's
launch to select centers of excellence in major markets. The important
milestone was announced at the 5 Continent Congress of Lasers and Aesthetic
Medicine which was held here on
"Early clinical data on the Zeltiq approach using a prototype device to
reduce the thickness of the fat layer with precisely controlled cooling is
very promising, provided there is careful patient selection and direct
physician involvement in treatment planning," said
Cryolipolysis(TM), the science behind the Zeltiq Procedure, was
discovered by dermatologists
Speaking on the podium, Dr. Manstein explained: "Our basic research
demonstrated the natural biologic vulnerability of fat cells to controlled
cold exposure." He said that his
According to Dr. Henry HL Chan, who was the first physician to
commercially introduce the procedure in his dermatology practice in
Addressing Congress attendees, Dr. Chan noted: "Our patients report 100% satisfaction and significant fat reduction in two to four months following a single Zeltiq Procedure. In fact, we have had satisfied patients come back for a second procedure to achieve more fat reduction. I attribute this to the fact that the Zeltiq Procedure is comfortable, there is no downtime, and patients can see and feel a noticeable contour change in stubborn fat bulges such that they remark how much better their clothes fit." Dr. Chan also pointed out that his patients have experienced no complications.
Clinical Study Results
Zeltiq conducted the first human study to test the safety and efficacy of its device for fat layer reduction of love handles and back fat pads in men and women. The unique bilateral control study design showed unequivocal results at relatively low energy settings with an early clinical prototype device. Based on ultrasound assessment, an average fat layer reduction of 22.4% was demonstrated after only one procedure.
Continued technology advancements in the device, combined with use of higher rates of tissue cooling and repeat procedures were shown to improve results with no increase in adverse events or patient discomfort. Further, the initial procedure followed by a second procedure two to three months later appears to provide incremental fat reduction with apparent safety.
About Zeltiq Aesthetics
Zeltiq Aesthetics, founded in 2005, is a science-based medical device
company dedicated to the development of non-invasive procedures for the
reduction of unwanted fat tissue. The initial Cryolipolysis research and
patents were originated at The Wellman Center by Dr.
The Zeltiq Procedure is cleared by Health Canada and the European Union
for non-invasive fat layer reduction through cold-assisted lipolysis and is
available for sale to physicians on a limited basis in the European
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