ISELIN, N.J., Aug. 18 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, announced today that REPEL-CV, the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received approval from the Ministry of Health of the Russian Federation for use in all patients who undergo open heart surgery. REPEL-CV will be marketed throughout Russia by Cardiomedics, Ltd., a distributor of cardiac surgery products. Marc Sportsman, SyntheMed's Vice President of Sales, stated, "We are pleased that this regulatory and clinical evaluation process has been successfully completed and we can proceed with the launch of REPEL-CV in this important market."
REPEL-CV is FDA approved for use in pediatric cardiac surgery patients and is marketed in the United States through a direct sales force. It also has CE Mark approval for use in all cardiac surgery patients and is marketed in the European Union and certain other international countries through a network of independent distributors.
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.
REPEL-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the extent and severity of adhesions (scar tissue) that form between the surface of the heart and opposing tissue surfaces following the surgical procedure. It is designed to perform the ther
|SOURCE SyntheMed, Inc.|
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