FDA approves PMA for SyntheMed pediatric cardiac surgery device

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SyntheMed has gained pre-market approval (PMA) from the FDA for its Repel-CV Adhesion Barrier for use in pediatric cardiac surgery patients.

Biomaterials company SyntheMed said its Repel-CV is a bioresorbable film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the formation of post-operative adhesions.

Repel-CV will be marketed in the U.S. through a direct sales force of both company and independent sales representatives, according to the Iselin, N.J.-based SyntheMed. Repel-CV has CE Mark approval for use in cardiac surgical patients, and is currently marketed through a network of independent distributors in the European Union and in several Southeast Asian countries.