SyntheMed, Inc. is a biomaterials company engaged in the development and commercialization of anti-adhesion products. SyntheMed reached a major milestone when the company announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-Market Approval application for REPEL-CVÂ® Adhesion Barrier for use in pediatric cardiac surgery patients.
One of the unique aspects of REPEL-CV is that it 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).
Robert P. Hickey, who serves as the President and CEO of the company, stated, “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.”
As far as distribution goes, 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.
With a state-of-the-art product that will be marketed across the globe, SyntheMed Inc. may have hit a homerun with the production of REPEL-CV.