March 9, 2009
FDA OKs kids’ cardiac adhesion barrier
The U.S. Food and Drug Administration says it's approved a device that reduces the severity of adhesions in children undergoing open-chest surgery.
The FDA said Repel-CV is a synthetic film barrier that is inserted over the heart just before a surgeon closes the chest following the procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.
Designing and testing medical devices for children is challenging because they are still growing, said Daniel Schultz, director of the 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. of Iselin, N.J.