Researchers at the University of California, Irvine have successfully performed preclinical laboratory testing of a replacement heart valve intended for toddlers and young children with congenital cardiac defects, a key step toward obtaining approval for human use. The results of their study were published recently in the Journal of the American Heart Association.

The management of patients with congenital heart disease who require surgical pulmonary valve replacement typically occurs between the ages of 2 and 10. To be eligible for a minimally invasive transcatheter pulmonary valve procedure, patients currently must weigh at least 45 pounds. For children to receive minimally invasive treatment, they must be large enough so that their veins can accommodate the size of a crimped replacement valve.

The Iris Valve, designed and developed by the UC Irvine team, can be implanted in children weighing as little as 17 to 22 pounds and gradually expanded to an adult diameter as they grow.