VelaShape III Platform from Syneron Receives FDA Clearance for Abdominal Circumferential Reduction
The VelaShape III, Syneron's new non-invasive body shaping platform, recently received FDA clearance and CE mark approval for temporary reduction in circumference of the abdomen. The VelaShape III can also be used in a wide range of other body shaping applications such as cellulite treatments.
"In a VelaShape III clinical study 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, MD, Global Vice President of Clinical Affairs, in a company release. "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."
As the third generation, VelaShape III builds on the success of the original VelaShape technology. According to the company, based on the proven energy combination technology of elōs and with the extensive scientific and clinical experience accumulated from all the Vela brands, the new VelaShape III system also comes equipped with a many 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 state-of-the-art design with a highly optimized and user-friendly interface, according to Syneron.
"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, MD in a press release. "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." Dr. Brightman, a board certified dermatologist at the Laser & Skin Surgery Center of New York, was one of the lead investigators for the original and the new VelaShape III system.