Photo Credit: syneron.com
Body shaping has come a long way, baby! Syneron Candela, one of the worldâ€™s leaders in aesthetic devices (think laser and radiofrequency) has just received FDA clearance for its UltraShape System, which targets fat cells and makes them go awayâ€”forever.
Technically, it is the first and only non-invasive body shaping treatment that uses pulsed focused ultrasound energy to precisely target subcutaneous fat. The surrounding tissue, blood vessels, and muscles are not affected at all. Unlike other body shaping technologies, UltraShape uses a pure mechanical effect to destroy fat cells without using heat. This unique feature of the UltraShape technology results in a safe and comfortable treatment experience.
UltraShape joins Syneron’s other body shaping device, VelaShape III, which works with elÅs based thermal technology. These two FDA cleared technologies offer a wide range of body shaping options including circumferential reduction in various body areas and reduction in cellulite appearance.
Prior to the FDA approval, UltraShape had been used in Europe, Asia, and Canada since 2005, and US physicians were clamoring to see the technology arrive stateside.
â€œUltraShape uses non thermal ultrasound providing efficacy and the non-heat dependent energy is tolerated well by the patients,” said Jeffrey M Kenkel, MD, FACS, Professor and Vice Chairman of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center at Dallas, one of the primary investigators in the FDA-required study of the device.
A clinical study of UltraShape with 150 subjects was performed at three clinical sites in the U.S. and one site outside of the U.S. Study results showed that the treatment had an average reduction of 2.5 cm (thatâ€™s basically 1 inch) in circumference of the treated areas*.
According to William Coleman M.D., Clinical Professor of Dermatology, Adjunct Professor of Surgery (Plastic Surgery), Tulane University Health Sciences Center and a principal investigator in the FDA study, “In our practice, patients were very satisfied with the results of the UltraShape treatment.”
Since receiving the CE mark (the European Unionâ€™s certification of approval), the device has been used in over 300,000 procedures worldwide.
UltraShape will be available in the US in mid May 2014. Visit ultrashape.comÂ
*Study on file with Syneron.