Anti-Scarring Heart Film Tested

SyntheMed said Wednesday the U.S. Food and Drug Administration accepted its pre-market approval application for REPEL-CV for heart surgery.

REPEL-CV is a bioresorbable film intended to reduce post-operative scar tissue, or adhesions, after open heart surgery.

The FDA acceptance of our PMA filing marks another important step toward our goal of making REPEL-CV available to patients in the United States who may require secondary open heart surgery, said Robert Hickey, SyntheMed’s president and CEO.

Adhesions pose serious health risks to patients who have cardiac reoperations as well as result in higher costs for the hospitals where these procedures are performed, Hickey added. Our clinical trial results have demonstrated that REPEL-CV has the potential to reduce OR time, patient exposure to anesthesia and other complications associated with cardiac adhesions.

REPEL-CV is approved and on the market in the European Union and several Asian countries.