A device that helps reduce the severity of adhesions in children who have open heart surgery has been approved by the U.S. Food and Drug Administration.
The Repel-CV device is a manufactured film barrier that's inserted over the heart just before the surgeon closes the chest, the agency said in a news release. It helps minimize adhesions, which are bands of scar tissue that develop after surgery.
After open heart surgery, cardiac adhesions may bind the heart's outer membrane to surrounding tissue. This can hamper the heart's activity and lead to other complications, especially for children who require additional operations, the FDA said.
Up to 400,000 children in the United States have been born with heart abnormalities, many of whom needed multiple surgeries to correct their conditions. Repel-CV is meant for children who are likely to require additional heart surgery.
The device is made by SyntheMed Inc. of Iselin, N.J.