FDAnews Device Daily Bulletin

SyntheMed received Health Canada approval for the use of Repel-CV to reduce adhesions in pediatric patients who undergo open-heart surgery.

Adhesions occur after most open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and surrounding tissue surfaces. They are considered a serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure, according to SyntheMed.

The product is a bioresorbable adhesion barrier film that is placed over the surface of the heart after surgery to reduce the extent and severity of adhesions. It later degrades and is cleared from the body.