FDA Approves SyntheMed’s REPEL-CV® Adhesion Barrier for Use in Pediatric Cardiac Surgery

SyntheMed, Inc., a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration has approved the Pre-market Approval application for REPEL-CV® Adhesion Barrier for use in pediatric cardiac surgery patients.

ISELIN, N.J., March 9 — 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® 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.

Source: Cardiac Adhesions

published: March 10, 2009 in: Cardio, Companies, Products, Regulatory, Specialty, USA

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