• Cynosure (Westford, Massachusetts), maker of light-based aesthetic treatment systems, said it has received FDA clearance for its Smartlipo system for laser-assisted lipolysis, or LaserBodySculpting, a procedure that disrupts fat cells and causes coagulation of the tissue leading to skin tightening. The LaserBodySculpting uses a small cannula 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, Cynosure says. Cynosure develops and markets aesthetic treatment systems.

• EthiconWomen’s Health & Urology (Somerville, New Jersey) said results from a multicenter, prospective clinical trial showed that nine out of 10 women undergoing treatment with Gynecare Thermachoice III Uterine Balloon Therapy System to treat menorrhagia, heavy menstrual periods, returned to a normal bleeding rate or less. The data were presented last week at the annual meeting of the American Association of Gynecologic Laparoscopists (AAGL; Cypress, California) in Las Vegas. Women in the 250-patient trial were randomized to receive postablation curettage (PAC) or to no PAC following treatment with Gynecare Thermachoice III. The success rates in the groups were comparable. At the 12-month follow-up point, the intent-to-treat analysis showed that 37% of women experienced amenorrhea (no menstrual bleeding). The study also compared this amenorrhea rate to that of historic patient-matched controls. Among the intent-to-treat matched patients, the amenorrhea rate was 32.6%, which is significantly greater than the 13.7% reported in the matched patients from the Thermachoice I study.