SyntheMed has received approval from the Ministry of Health of the Russian Federation for use of REPEL-CV in all patients who undergo open heart surgery.
Reportedly, REPEL-CV is a bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery.
The company said that REPEL-CV will be marketed throughout Russia by Cardiomedics, a distributor of cardiac surgery products.
According to the company, REPEL-CV is FDA approved for use in pediatric cardiac surgery patients and is marketed in the US 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.
Marc Sportsman, vice president of sales at SyntheMed, said: 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.