Bioresorbable Polymer Prevents Cardiac Scarring After Surgery

Formal approval has been given in the United States for marketing of a type of bioresorbable polymer that reduces or eliminates scarring during healing from cardiac surgery.

The [U.S.] Food and Drugs Administration (FDA) recently granted premarket approval for the first product of this type, REPEL-CV(r) Adhesion Barrier, for use in pediatric patients (21 and younger) who are likely to need secondary open-heart surgery. REPEL-CV is the fruit of collaboration between SyntheMed Inc. (Iselin, NJ, USA) and the Hebrew University of Jerusalem (Israel).

SyntheMed's research and development projects have encompassed a broad range of bioresorbable polymeric compositions. Bioresorbable polymers perform a therapeutic task in the body and then degrade safely into fragments that are either metabolized or eliminated via normal excretory routes.

In a randomized, controlled, clinical trial conducted at 15 pediatric cardiothoracic surgery centers, REPEL-CV Bioresorbable Adhesion Barrier was placed over the surface of the heart at the conclusion of an open-heart surgery procedure to minimize the formation of postoperative adhesions. Once in place, it acted as a temporary barrier to physically separate opposing surfaces to reduce the risk of their becoming connected through the formation of fibrin bands during the early phase of wound healing. By placing REPEL-CV Adhesion Barrier between the traumatized tissue surfaces, the formation of the interconnecting fibrinous bands between adjacent surfaces was blocked, and the development of fibrinous adhesions was reduced. It was then absorbed at the implant site in approximately one month.

"This biomedical product harnessed the unique properties of a family of custom-made, biodegradable polymers aimed at treating a large, incredibly widespread clinical problem, which pertains to all surgeries: post-operative adhesions. Each and every surgery conducted inevitably results in post-surgical adhesions, and the polymeric film developed at the Hebrew University allows us to minimize those adhesions," said Dr. Daniel Cohn, professor of biomaterial science at the Hebrew University of Jerusalem.

Related Links:
SyntheMed Inc.
Hebrew University of Jerusalem