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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.

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