The US Food and Drug Administration has approved the first heart valve designed to grow with a child patient, offering hope to children born with valve defects.

The approval is based on a study of 62 children at 12 US hospitals. All procedures succeeded, with no deaths, strokes or blood clots needing treatment.

Two children who began outgrowing their valves had them widened without surgery. Longer-term studies are still underway, the FDA noted.

“Children with congenital pulmonary valve disease have long needed prosthetic valves that can account for growth over time,” said Dr Emile Bacha, surgeon-in-chief at NewYork-Presbyterian/Columbia, who worked on the trial.

The valve went through the FDA’s toughest review process, called premarket approval. It had earlier received Breakthrough Device status, which speeds review of promising devices.

Children with faulty pulmonary valves often need repeat open-heart surgeries as they grow. A valve that can be expanded later could cut the number of operations.

The device maker will continue tracking patients to confirm the long-term safety of the expandable design.