Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Create Health

A healthcare marketing agency that shares your passion for making things better. Our clients with solve real health problems every...

Latest intelligence

segmentation_pie_thumb.jpg
If you’re not thinking segmentation, you’re not thinking
Having a background in market research I’ve been lucky to work on a number of customer segmentations in my time but working in creative communications it is still too rare...
Improving Outcomes in the Treatment of Opioid Dependence Highlights Report
The 16th annual ‘Improving Outcomes in the Treatment of Opioid Dependence’ (IOTOD)conference took place at the Hilton Madrid Airport hotel on 15–16 May 2018....
Londonvelophobia (fear of cycling in London) – debunked
...

Infographics