SyntheMed awarded CE Mark for its adhesion barrier film used in cardiac surgery

By Lisa Kerner

Charlotte, N.C., Aug. 23 - SyntheMed, Inc. said it received CE Mark approval for Repel-CV, its bioresorbable adhesion barrier film placed over the heart after surgery to reduce adhesions (scar tissue).

Adhesions occur in almost all open-heart surgical procedures and can result in the heart becoming attached to the sternum.

CE Mark approval means Repel-CV meets the requirements of the E.U. Medical Devices Directive and that the company can now begin marketing the product for use in all cardiothoracic surgical procedures.

"Surgical adhesions represent a significant concern for patients who undergo secondary open-heart surgery, resulting in heightened risk of mortality and other complications, longer surgical procedures and additional medical costs," president and chief executive officer Robert P. Hickey said in a company news release.

"We have established a network of independent distributors to rapidly commercialize Repel-CV in the EU and look forward to bringing the demonstrated benefits of this product to both patients and physicians."

SyntheMed said in an open-label clinical study conducted at several European cardiac surgery centers, 13 of the 15 patients treated with Repel-CV were completely free of severe adhesions by the second surgical procedure.

A pivotal clinical trial in support of Food and Drug Administration approval is underway at 15 pediatric cardiac surgery centers.

SyntheMed is an Iselin, N.J., biomaterials company specializing in anti-adhesion and drug delivery products.

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