Relief for "Thigh Shy" Consumers: CoolSculpting(R) Receives FDA Clearance for Non-Surgical Reduction of Thigh Fat
April 14 2014 - 8:30AM
Marketwired
Relief for "Thigh Shy" Consumers: CoolSculpting(R) Receives FDA
Clearance for Non-Surgical Reduction of Thigh Fat
PLEASANTON, CA--(Marketwired - Apr 14, 2014) - ZELTIQ®
Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company
focused on developing and commercializing products utilizing its
proprietary controlled-cooling technology, today announced that the
CoolSculpting procedure has received U.S. Food and Drug
Administration (FDA) clearance to treat the thighs with its entire
suite of applicators. The CoolSculpting procedure is
clinically proven to non-surgically reduce unwanted fat, and is
already FDA cleared to treat the abdomen and flanks.
With its newest applicator, the CoolSculpting procedure is the
first and only clinically proven non-surgical solution using
cooling for fat reduction of the thighs. The newest applicator
utilizes non-vacuum based cooling, easily and specifically treats
the outer thighs and other non-pinchable fat bulges, and features a
comfortable design that adjusts to fit each individual
patient. In combination with an applicator launched last year
and designed to treat longer fat bulges and hard-to-reach areas
such as the inner thigh, the CoolSculpting procedure can now treat
the complete thigh area.
"In my practice, I have seen a growing number of patients who,
despite leading a healthy lifestyle through diet and exercise,
cannot eliminate stubborn fat on certain parts of their bodies, and
the thigh ranks high on the list of target spots they wish to
treat," said Grant Stevens, MD, medical director of Marina Plastic
Surgery in Marina del Rey, Calif. "Being able to perform this
procedure on three of the most challenging parts of the body -- the
abdomen, flank and now thighs -- presents additional opportunities
for my patients who want to improve the contour of their bodies
without surgery."
With this new indication, thighs join the abdomen and flank as
parts of the body successfully treated by the CoolSculpting
procedure. A recent market research study in the United States
revealed that 7.2 million people expressed an interest in the
CoolSculpting procedure as a solution for inner or outer thigh
fat1. This is in addition to the 13.2 million and 7.4 million
interested in undergoing the procedure for the abdomen and flank1,
respectively.
Through the use of different applicators, the CoolSculpting
procedure can be customized to treat different body types and
several areas of the body. In clinical studies, 86% percent of
patients reported a visible reduction in outer thigh fat 16 weeks
following treatment and were satisfied with results. Of note, 89%
of patients would recommend the CoolSculpting procedure to a
friend1.
The unique CoolSculpting procedure was developed by Harvard
scientists and is based on the science of Cryolipolysis®, a process
demonstrating that when fat cells are exposed to extreme cold, they
die and are eliminated naturally from the body. Only the
CoolSculpting procedure selectively targets (freezes) the fat cells
which, once crystallized, die and are naturally eliminated from the
body. Fat cells treated and eliminated by the procedure are
gone for good, and patients can expect long-lasting results.
In the United States, the CoolSculpting procedure is cleared for
non-invasive fat reduction in the abdomen, flank and
thighs. In other international markets, it is cleared for
general non-invasive fat reduction. The CoolSculpting
procedure results in a noticeable and measurable reduction of fat
in the treated areas, and the treated fat is gone for
good. Most patients can start to see results as soon as three
weeks following treatment, with the most dramatic results occurring
over a period of one to three months. Every patient is unique,
so patients are encouraged to talk to their physicians about a
customized treatment plan as part of the initial
consultation. Additional treatments in the same or multiple
areas may enhance the desired aesthetic effect.
The CoolSculpting procedure is available through an elite
network of CoolSculpting Centers worldwide. Dermatologists, plastic
surgeons and leading aesthetic specialists that offer CoolSculpting
can be found at www.coolsculpting.com.
About the CoolSculpting® Procedure The CoolSculpting procedure
is a non-surgical, clinically proven procedure that selectively
reduces fat bulges in problem areas using a patented cooling
technology. Cleared by the FDA for noninvasive fat reduction in the
abdomen, flank and thighs, it gently cools unwanted fat cells in
the body to induce a natural, controlled elimination of fat cells
without harming surrounding tissue, and the treated fat cells are
gone for good. Over 1,000,000 CoolSculpting cycles and 2,200
systems have been shipped to more than 60 countries. The
CoolSculpting procedure is available through an elite network of
CoolSculpting Centers worldwide. Dermatologists, plastic surgeons
and leading aesthetic specialists that offer CoolSculpting can be
found at www.coolsculpting.com.
Be sure to follow CoolSculpting on Facebook, Twitter, Pinterest
and YouTube.
About ZELTIQ® Aesthetics, Inc. ZELTIQ Aesthetics, Inc. is a
medical technology company focused on developing and
commercializing products utilizing its proprietary
controlled-cooling technology platform. ZELTIQ's first commercial
product, the CoolSculpting system, is designed to selectively
reduce stubborn fat that may not respond to diet or
exercise. The CoolSculpting procedure is based on the
scientific principle that fat cells are more sensitive to cold than
the overlying skin and surrounding tissues. It utilizes
patented technology of precisely controlled cooling to reduce the
temperature of fat cells in the treated area, which is intended to
cause fat cell elimination through a natural biological process
known as apoptosis. ZELTIQ developed the CoolSculpting
procedure to safely, noticeably, and measurably reduce the fat
layer.
1 Data on file
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