Approval by the Food and Drug Administration (FDA) of the LipoSonix device (Medicis) sits on hold. In July 2010, the FDA told the manufacturer that its original 510(k) application included insufficient data to support a finding of substantial equivalence to an existing device. Kara Stancell, Medicis vice president, investor and public relations and corporate communications, tells Cosmetic Surgery Times that because the LipoSonix system is not cleared for sale in the United States, it is inappropriate for the company to comment about its status. However, published accounts say, the additional data the FDA requested did not pertain to safety issues. The LipoSonix system uses focused ultrasound to treat persistent fat pockets that do not respond well to diet or exercise, according to Medicis. Joel Schlessinger, M.D., says that in European trials, the device has been shown to cause approximately 1 inch of circumferential decrease in the anterior abdomen. He is a board-certified dermatologist and cosmetic surgeon based in Omaha, Neb. "In the United States, we await publication of the manufacturer's final data and study results," he says. Disclosures: Dr. Schlessinger is an investigator for Kythera and Medicis and founder of the Cosmetic Surgery Forum, at which the LipoSonix material was presented. |
