Genzyme to file premarket approval (PMA) for Seprafilm use in surgery
This article was originally published in Clinica
Executive Summary
Genzyme (US) is ready to file a PMA application with the US FDA for use of its Seprafilm bioresorbable membrane in abdominal and pelvic surgery. This follows release of the results of an 18-centre clinical study which found that of 127 women undergoing myomectomy, those treated with Seprafilm (formerly HAL-F) developed "significantly fewer post-operative uterine adhesions" than untreated patients, the company claims.