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SMARTLIPO™ RECEIVES FDA APPROVAL First and only laser-assisted lipolysis device available in U.S. Westford, MA - November 9, 2006 - Cynosure, Inc., a leading developer and manufacturer of a broad array of light-based aesthetic treatment systems, today announced it has received clearance from the U.S. Food and Drug Administration for its Smartlipo™ system for laser assisted lipolysis, or LaserBodySculptingSM, a procedure that disrupts fat cells and causes coagulation of the tissue leading to skin tightening. The Smartlipo system provides aesthetic surgeons a new, less-invasive method for reducing fat cells. Cynosure believes the demand for liposuction and body sculpting procedures that remove or reduce fat cells is increasing. Nearly 500,000 liposuction procedures were performed in the U.S. in 2005, making it the number one surgical cosmetic procedure among both women and men according to the American Society for Aesthetic Plastic Surgery (ASAPS). According to Dr. Bruce Katz, Clinical Professor at Mt. Sinai School of Medicine in New York City, “I believe that the Smartlipo system is particularly useful for treating areas with localized fat deposits. In addition to disrupting fat, it coagulates and tightens tissue. We have seen excellent results with this new laser lipolysis procedure.” Performed under local anesthesia, the SmartLipo LaserBodySculpting system uses a small cannula, or tube, containing a laser fiber that is inserted into the skin and passed throughout the treatment area. The laser’s energy is applied directly to the fat cells, causing them to rupture and drain away. Treatments with the Smartlipo system generally result in less swelling and bleeding as compared to traditional liposuction methods and can usually be performed in one 45-minute session. “The Smartlipo laser lipolysis is a minimally invasive procedure that is well suited for the treatment of small areas,” said Karen Kim, MD, a board-certified dermatologist at the Laser Skin and Surgery Center of New York. “Our early clinical trials suggest that patients experience rapid healing with little tissue trauma. Post-operative results can be seen as soon as one week, with continued improvement over several months.”
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