FDA Approves the First Heart Valve Designed to Grow With a Child

The Food and Drug Administration has approved the first heart valve that doctors can enlarge as a child grows, a device that could reduce the number of open-heart surgeries faced by children born with defects of the pulmonary valve.

The Autus Size-Adjustable Valve, developed by Autus Valve Technologies, was approved on Thursday through the agency’s most rigorous review pathway, premarket approval, which is reserved for devices that pose the greatest potential risk, according to the FDA and HealthDay. Edwards Lifesciences received the approval, the FDA said. The device had earlier been granted breakthrough designation.

The engineering problem it addresses is simple to describe and hard to solve. Replacement valves come in fixed sizes, so a child who receives one young will eventually outgrow it. Valves made from animal tissue also tend to stiffen and break down faster in children. Both problems have meant repeated operations.

The new valve is implanted at about 13 millimeters. As the child grows, doctors can widen it to about 22 millimeters, close to adult size, using a balloon threaded through a blood vessel rather than opening the chest. Its leaflets, the flaps that open and close with each heartbeat, are made of a polymer instead of animal tissue. The FDA said it is the first valve approved in the United States with polymeric leaflets, and the first approval of that leaflet material for any use. One-year follow-up suggests the synthetic leaflets hold up well.

The approval rests on a study of 62 children at 12 hospitals in the United States. All implant procedures succeeded, with no deaths, no strokes and no clot-related complications requiring treatment, both the FDA and HealthDay reported. Two children whose valves began to falter as they outgrew them had the devices widened successfully without surgery. The FDA also noted that three patients had a fracture in the valve frame and two had reduced leaflet movement, none with symptoms.

Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said the valve gives doctors the option of far fewer trips to the operating room. Dr. Emile Bacha, a surgeon at NewYork-Presbyterian and Columbia University Irving Medical Center who took part in the trial, told HealthDay that children with the condition have long needed valves that can account for growth.

The need is substantial. About 1 in 100 babies in the United States is born with a congenital heart defect, and narrowing or absence of the pulmonary valve affects about 4,200 babies a year, according to the Centers for Disease Control and Prevention.

Caution is still warranted. The FDA said experience with expanding the valve remains limited, and longer-term studies are under way to confirm that it keeps working as it is widened and that it truly reduces the number of surgeries over a childhood.