FDA approves first expandable pediatric pulmonary heart valve

The FDA has cleared a new surgically implanted pulmonary valve designed for children with congenital pulmonary valve disease.

The device, called the Autus Size-Adjustable Valve, was developed by Edwards Lifesciences after acquiring Autus Valve Technologies. It can be expanded after implantation to accommodate a child's growth, potentially reducing the need for multiple open-heart surgeries.

It is also the first U.S. approved heart valve that uses a polymer material for its leaflets instead of animal tissue. The FDA highlighted the limited options previously available for pediatric patients.

Congenital pulmonary valve disease affects roughly 11.3 per 10,000 live births in the United States, making it one of the more common birth defects. The new valve aims to improve long-term outcomes for these children.