Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: Genzyme Seprafilm gynecological trial

This article was originally published in The Gray Sheet

Executive Summary

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)...
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT004714

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel