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ISELIN, N.J., March 9 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA) application for REPEL-CV(R) Adhesion Barrier for use in pediatric cardiac surgery patients. 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 (scar tissue).
"The FDA approval of REPEL-CV as the first anti-adhesion product for use in cardiac surgery marks a major milestone for our company," stated Robert P. Hickey, President and Chief Executive Officer, SyntheMed, Inc. "We now look forward to providing US-based cardiac surgeons with a means of reducing the risks to which their pediatric patients are routinely exposed during secondary open-heart surgical procedures. We are engaged in discussions with FDA personnel to define the clinical data required to expand the use of REPEL-CV to include adult cardiac surgery patients."
REPEL-CV will be marketed in the United States 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 European Union and in several Southeast Asian countries.
About Cardiac Adhesions
Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surrounding tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure.
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| SOURCE SyntheMed, Inc. Copyright©2009 PR Newswire. All rights reserved |
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