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Paediatric cardiac adhesion barrier approved

The US FDA announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery

On March 6 the US Food and Drug Administration (FDA) announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery. In July 2008 the product received Health Canada approval and prior to this SyntheMed was granted CE Mark approval to market Repel-CV in most international markets. The US approval follows completion of field inspections.

Repel-CV, which is manufactured by biomaterials company SyntheMed in New Jersey, 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.

In the US, 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.

In the UK there are approximately 4,600 babies born with congenital heart disease each year (one in every 145 births).

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 per cent of the surgical site. Patients who did not receive Repel-CV were found to have severe adhesions occupying 47 per cent 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."

9th March 2009

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