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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
March 6, 2009

Media Inquiries:
Siobhan DeLancey, 301-796-4668
Consumer Inquiries:
888-INFO-FDA


FDA Approves Cardiac Adhesion Barrier for Pediatric Use
Device Reduces Severity of Surgical Adhesions after Open-Heart Surgery

The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.

Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.

Adhesions are bands of scar tissue that develop after surgery, infection, or other trauma. The bands can develop in any part of the body but are most commonly found in the abdomen, pelvis, or chest. Cardiac adhesions bind the outer membrane of the heart to surrounding tissue, which may restrict heart activity and complicate any additional surgical treatment. While scar tissue is part of the body's natural healing response, adhesions can become densely fibrous and difficult to surgically navigate, which can pose problems for patients who require repeat surgeries.

In the United States, there are 350,000 to 400,000 children with congenital cardiac abnormalities. Many neonatal and infant patients must undergo multiple surgeries before their defect is corrected while other children require additional operations as they grow. This product gives physicians another tool to help decrease this type of complication that may occur.

Repel-CV is intended for children who are likely to require additional heart surgery. In a clinical study, patients who received Repel-CV were found to have less area of severe adhesions — 21 percent of the surgical site. Patients who did not receive Repel-CV were found to have severe adhesions occupying 47 percent of the surgical site.

"Designing and testing medical devices for children is challenging because they are still growing," said Daniel G. Schultz, director of FDA's Center for Devices and Radiological Health. "Approval of Repel-CV is an example of FDA's commitment to work with regulated industry to make more safe and effective pediatric medical devices available."

Repel-CV is manufactured by SyntheMed Inc. in Iselin, N.J.

 

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