SyntheMed, Inc. (OTCBB: SYMD), a biomaterials company engaged in the development and commercialization of medical devices for therapeutic applications, recently announced that their bioresorbable adhesion barrier film for reduction of adhesions following cardiac surgery, REPEL-CV®, received approval from Health Canada to be used in pediatric patients who undergo open heart surgery. The Montreal based distributor of cardiac surgery products, Force3 Medicale, Inc., will be responsible for the marketing of REPEL-CV.
SyntheMed’s Vice President, Marc Sportsman, said, “We are pleased to receive the Health Canada approval which allows us to further expand the international distribution of REPEL-CV.”
The company offers products based on proprietary, bioresorbable polymer technology. Other products include REPEL-AFINB, which reduces the patient risk associated with a trial fibrillation; RESOLVE, which prevents or reduces post-operative surgical adhesions in gynecological and general abdominal surgery; and RELIEVE for preventing or reducing post-operative surgical adhesions in orthopedic and spinal surgery.
SyntheMed was granted CE Mark approval to market REPEL-CV within many international markets for use in all patients who undergo open heart surgery, and is being sold through a network of independent distributors. During November of 2007, the company 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. Currently, this process is still taking place as both the company and the FDA are engaging in conversations on the requirements for expansion of the indication for REPEL-CV from pediatric patients to all patients who undergo cardiac surgery.
Let us hear your thoughts below: