In Brief: Genzyme Seprafilm gynecological trial

Genzyme Seprafilm gynecological trial: Cambridge, Massachusetts-based Genzyme reports results from a multicenter trial evaluating its Seprafilm bioresorbable membrane for preventing surgical adhesions in gynecological surgery. Approximately half of 127 women receiving myomectomies at 18 centers were treated using Seprafilm, Genzyme says. After a blinded follow-up examination of the women, it was determined that the Seprafilm group had: "fewer adhesions to the uterus"; "less surface area of the uterus affected by adhesions"; "uterine adhesions that were less extensive"; and "uterine adhesions that were less severe," the company says. Genzyme, which announced results in January from a trial using Seprafilm (formerly called Hal-F ) in abdominal procedures, says it plans to submit a premarket approval application with FDA next month for both abdominal and pelvic applications. The company recently received notice from FDA that its PMA for Seprafilm will receive expedited review status ("The Gray Sheet" Aug. 14, In Brief)...