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Archive for the ‘UltraShape’ Category

UltraShape Expected to Receive FDA Clearance for Contour I System

Posted by Cosmetic Surgery Review on July 1, 2010

UltraShape Ltd., the makers of the UltraShape body contouring and fat reduction system, has announced that it has applied for a request for clearance of its Contour I system with the United States Food and Drug Administration. The company is seeking approval under the 510(k) regulation rather than as  Pre-Market Approval (PMA).  This means that the company may receive approval more quickly, because the submission and clearance process with the FDA will be shortened.

According to Assaf Eyal, UltraShape CEO, “The United States is the largest and most important market in the world and represents a huge opportunity for our products. Submission for FDA market clearance under the 510(k) regulation is a major milestone for UltraShape. The recent launch of our new third generation product, together with our efforts to gain regulatory approval in the Untied States and China, provide us with a major growth opportunity.”

The Contour I System is currently begin marketed in more than 50 countries in Europe, Asia, South America, North America, Canada and Mexico. The company has introduced several products to U.S. markets since 2005, and medical spas and cosmetic surgery centers around the world have treated over 175,000 patients.

The Contour I device works using focused ultrasound energy waves to disrupt the fat cells and assist with fat cell tissue breakdown, without affecting the surrounding structures. Contour I is a trademark of UltraShape Ltd., and has not been approved for sale in the United States.

UltraShape is a non-invasive fat reduction system that promises to deliver results in as little as two weeks after treatment. There is no bruising or swelling involved with this procedure, and no downtime. Some practitioners believe that this is the “gold standard” in fat reduction and body contouring, and can safely reduce fat deposits in both men and women.

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UltraShape Trials Published in Plastic Surgery Journal

Posted by Cosmetic Surgery Review on February 7, 2009

UltraShape has become one of the most-talked about nonsurgical liposuction treatments on the market in Europe and Canada, but it has yet to make its debut in the United States.  The ultrasound-based procedure that promises to melt away fat and contour the body has helped hundreds of overseas patients trim down their figures, but is still undergoing clinical trials in the United States.

UltraShape has recently published extensive scientific and pre-clinical research data on ultrasound technology in the Plastic and Reconstructive Surgery journal, an internationally-recognized publication that features the latest results and statistics about many controversial procedures.

According to a recent press release that quotes Spencer Brown, PhD, Director of Research, Department at the University of Texas Southwestern Medical Center of Plastic Surgery and the UltraShape Medical Advisory Board,

“This extensive research confirms that the UltraShape(R) Contour I(TM) system is the first non-invasive technology to produce a non-thermal focused acoustic field at a controlled subcutaneous target resulting in stable cavitation,”
Histopathologist reviewed specimens of dermal and sub-dermal tissue, including subcutaneous fat, demonstrated selective fat cell destruction with preservation of surrounding critical structures such as skin, blood vessels, nerves and connective tissue. No epidermal or dermal changes were observed clinically or histologically.”

This statement is the first formal declaration about the effectiveness of the UltraShape system for fat reduction, and points out that skin tissues and blood vessels around the treatment area may be protected from damage throughout the procedure.

UltraShape may soon be a convenient, affordable and effective alternative to liposuction, especially for patients who are interested in losing a few ‘vanity pounds’ or stubborn deposits of fat that have become resistant to diet and exercise.  Liposuction is currently the only permanent way to get rid of fat cells, but there are a number of risks and involved, including extensive tissue damage, swelling, bruising and dimpling.

So far, UltraShape has shown promising results for treating areas such as the abdomen, thighs, buttocks and lower waist. The claims made by the makers of UltraShape are now backed by some solid scientific evidence, but trials will continue on through 2009 for additional confirmation.

A short video about how UltraShape works and its potential benefits can be viewed here:

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UltraShape Questions Answered By ‘Good Morning America’ Contributor

Posted by Cosmetic Surgery Review on January 13, 2009

UltraShape Fat LossUltraShape has been making waves overseas, a fat reduction procedure that is proving to be an effective way to lose extra pounds and inches – and all without a single incision.

Good Morning America contributor Dr. Marie Savard recently answered some questions about this increasingly popular procedure, highlighting several benefits of this non-invasive treatment.

UltraShape works by destroying the fat cells completely, which means the patient will not gain weight in the same areas if their weight increases at a later point in life.  This is similar to the results of liposuction, and Dr. Savard suggests that there “really is no reason to believe that destroying fat cells would cause any long-term or serious harm to people’s bodies.” (Source: ABCNews.com)

Dr. Savard also explains that the fat that is released is not significant enough to be reabsorbed by the body, a common concern for those considering UltraShape.  The liver and metabolism can efficiently shuttle away the excess fat in the urine or burn it up as energy immediately.  Patients still need to maintain a healthy diet and exercise regimen in order to maintain results, and UltraShape is not designed to be a quick fix solution for those who are overweight or obese.

UltraShape has been approved in Canada and many countries in Europe since its market launch in 2005.  It has recently made its way to Japan, and may soon be entering the U.S. market if it receives FDA approval.  People have been reporting outstanding results with no side effects, and the procedure may be particularly effective for people who are already at a relatively healthy weight but cannot lose those last few stubborn inches in ‘problem areas.’

Ultimately, UltraShape is another body contouring procedure that may help many people lose a few inches and improve their silhouette.  It is also significantly cheaper than liposuction, making it especially attractive to those who are on a tight budget.

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Contour Plus May Be New Alternative to Liposuction

Posted by Cosmetic Surgery Review on October 31, 2008

While liposuction continues to be one of the most popular fat removal and fat reduction methods for millions of men and women that want to get rid of stubborn body fat, many turn to non-surgical treatments such as VelaSmooth and mesotherapy to achieve their ideal figure.  The makers of UltraShape, an increasingly popular ultrasound device available in Europe and Canada that helps dissolve body fat, have recently launched a study using Contour Plus, a body contouring system designed to sculpt and tone the skin while tightening up the skin tissues.

The Contour Plus device is designed specifically for patients who have localized areas of fat that cannot be treated with liposuction alone; it works using ultrasound waves that penetrate deep into the skin and help break down fatty tissues immediately.

Millions of men and women pursue fat removal procedures such as SmartLipo and tumescent liposuction to get rid of love handles, streamline their silhouettes and create a more contoured appearance.  However, liposuction often results in a ‘bumpy’ appearance or leaves behind loose skin that must be managed with skin tightening treatments that sculpt and tone up the skin tissues after the procedure.

The Contour Plus treatment presents a less-invasive option for smoothing out the skin and creating a truly sculpted, natural-looking silhouette.

According to Dr. Sue Ellen Cox, Medical Director at Aesthetic Solutions in North Carolina, Other body contouring devices are notorious for over-promising and under-performing such as the VelaSmooth which is used more for temporary cellulite reduction. This is the first real non-invasive device that can achieve a reduction of fat. The Contour Plus can actually be shown to disrupt the fat cells, so there is actually an objective change going on and not only a subjective change.”

(Source: Cosmetic Surgery Times)

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LipoSonix May Be Future of Surgery-Free Liposuction

Posted by Cosmetic Surgery Review on July 19, 2008

While ultrasound technology for liposuction is already showing promising results overseas, the U.S. is still waiting for further testing before unveiling it at body contouring centers across the country.

UltraShape continues to enjoy ongoing success in the U.K. and Australia. It is an ultrasound-based lipo procedure that helps break down fat cells and reshape the body without surgery, needles or anesthesia. UltraShape works by emitting powerful ultrasound energy waves into the skin tissues and breaking down the fat cells – all without damaging the surrounding tissue and skin.

LipoSonix may be the U.S. version of UltraShape, and the makers of this system plan to launch it in the U.S. by 2011. LipoSonix is a 100% non-invasive procedure that reaches deep within the skin’s layers to break down trapped fat cells. Since there is no cannula involved to vacuum out the fat, patients can return to regular activities immediately after treatment. The fat cells are eliminated through the body’s lymphatic system, and most people will see results after a series of treatments.

Medicis recently announced its purchase of LipoSonix for $150 million, and is ready to pay another $150 million if LipoSonix receives FDA approval. LipoSonix may soon join several ultrasound liposuction treatments available around the globe, but Americans will need to wait a few years – or travel overseas – to enjoy the benefits of incision-free liposuction.

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