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Syneron Medical Receives FDA Clearance For Abdominal Circumferential Reduction And CE Mark For The New VelaShape® III Platform

IRVINE, California, September 10, 2013 /PRNewswire/ --


In a clinical study of forty-two patients, an average abdominal circumference reduction of 2.6 cm was achieved following a single VelaShape  III treatment protocol

Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced Food and Drug Administration (FDA) clearance and CE mark approval for VelaShape® III [1], the Company's new non-invasive body shaping platform. This new platform is effective for temporary reduction in circumference of the abdomen and is also used in a wide range of other body shaping applications such as cellulite treatments.

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"In a VelaShape III clinical study [2] of forty-two patients an average abdominal circumference reduction of 2.6 cm was recorded post 10 weeks following a single treatment," said Ruthie Amir, M.D., Global Vice President of Clinical Affairs. "Within the same study, we uncovered that 100 percent of the patients responded to the single treatment protocol with an abdominal circumference reduction of at a least 1.5 cm, with results seen as early as two weeks."

Since its introduction in 2008, with more than 10,000 procedures performed daily and over 40 published clinical studies, VelaShape remains the most trusted brand for cellulite treatment and non-invasive body shaping by physicians, beauty experts and millions of patients worldwide. As the third generation, VelaShape III builds on the success of the original VelaShape technology, which pioneered the category in non-invasive body shaping and cellulite reduction industry for physicians and consumers.

Based on the proven energy combination technology of elōs® and with the extensive scientific and clinical experience accumulated from all the Vela [3] brands, the new VelaShape III system also comes equipped with a multitude of new features designed to significantly reduce the number of treatments while reducing the percentage of non-responders. Some of these new features include increased radio-frequency power of up to 150W, sophisticated real time feedback mechanisms for consistent RF delivery independent of tissue variations and a built-in, real time tissue surface temperature sensor. The system also offers a complete range of new tip configurations for various body locations. All these advanced features have been packaged into a sleek, state-of-the-art design with a highly optimized and user-friendly interface.

The VelaShape III platform is set to be a body shaping powerhouse. "In clinical trials we found that we can achieve a quicker temperature end point in a matter of minutes with VelaShape III as opposed to the prolonged time required by the previous device," said Lori Brightman, M.D., board certified Dermatologist at the Laser & Skin Surgery Center of New York and one of the lead investigators for both the original and the new VelaShape III system.  "By reaching temperature endpoint quicker, practitioners can use the valuable time to maintain the necessary temperature to effectively complete the treatment in a much shorter session."

Painless and fast-acting, VelaShape III is proven to be safe and effective in significant waist circumference reduction - a common problem area that can be resistant to exercise and dieting which add to its other well established indications including treatment of cellulite and thigh circumferential reduction.  

According to a survey of over 1,000 American women commissioned by Syneron Medical, seven in ten (70 percent) admit they are most concerned about developing a tummy bulge now and in the future (66 percent). [4] The launch of the new Velashape III platform meets the growing demand for affordable, practical and comfortable non-invasive body shaping techniques.

Dr. Shimon Eckhouse, Chief Executive Officer of Syneron, commented, "We designed a sophisticated body shaping platform that delivers visible outcomes in a single or small number of treatments, fits the doctor's business needs and leads the body shaping category to the next level. Together with our physician partners and engineers, our customers now have a clinically proven solution that addresses what consumers are telling us they want."

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