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news.SyntheMed, a biomaterials company, has announced that the FDA has approved the pre-market approval application for Repel-CV adhesion barrier for use in pediatric cardiac surgery patients.
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According to SyntheMed, 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 US through a direct sales force comprised of both company and independent sales representatives. Repel-CV has CE Mark approval for use in all cardiac surgical patients and is currently marketed through a network of independent distributors in the EU and in several Southeast Asian countries.
Robert Hickey, president and CEO of SyntheMed, said: “The FDA approval of Repel-CV as the first anti-adhesion product for use in cardiac surgery marks a major milestone for our company. We are engaged in discussions with the FDA personnel to define the clinical data required to expand the use of Repel-CV to include adult cardiac surgery patients.”