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ISELIN, N.J., July 14 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion, drug delivery products and other surgical implants, announced today that REPEL-CV(R), the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received Health Canada approval for use in pediatric patients who undergo open heart surgery. REPEL-CV will be marketed throughout Canada by Force3 Medicale, Inc., a Montreal-based distributor of cardiac surgery products. Marc Sportsman, SyntheMed's Vice President of Sales, stated, "We are pleased to receive the Health Canada approval which allows us to further expand the international distribution of REPEL-CV."
SyntheMed was previously granted CE Mark approval to market REPEL-CV in most international markets for use in all patients who undergo open heart surgery and is being sold through a network of independent distributors. In November 2007, SyntheMed received an Approval Letter from the US FDA stating the REPEL-CV would be approved for use in pediatric patients pending satisfactory completion of field inspections. This process is ongoing as are discussions with the FDA on the requirements for expansion of the indication for REPEL-CV from pediatric patients to all patients who undergo cardiac surgery.
About 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.
About REPEL-CV
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
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