Plate Nº 28 · recorded October 2, 2026
Health & Medicine ResearchReported finding
FDA Approves First Heart Valve That Grows With a Child
The FDA has approved the Autus valve, the first heart valve that doctors can widen as a child grows, potentially sparing young patients repeated open-heart surgeries.
By Nathan Brooks3 min read576 words
In brief
- The FDA approved the Autus Size-Adjustable Valve, the first heart valve designed to be expanded after implantation in a growing child.
- Doctors can widen the valve from about 13 millimeters to 22 millimeters using a balloon threaded through a blood vessel, without open-heart surgery.
- In a trial of 62 children at 12 U.S. hospitals, all procedures succeeded, with no deaths, strokes or treated blood clots; long-term studies are still underway.
Children born with certain heart defects may need fewer open-heart surgeries after a U.S. regulatory decision this week. On Thursday, the Food and Drug Administration (FDA) approved the Autus Size-Adjustable Valve — the first replacement heart valve designed to be expanded after implantation as a patient grows.
The valve is intended for children with congenital pulmonary valve disease, a condition affecting the valve that controls blood flow from the heart to the lungs. Congenital heart defects are among the most common birth defects in the United States, affecting roughly one in 100 babies. According to the Centers for Disease Control and Prevention (CDC), two pulmonary valve conditions — stenosis, in which the valve is narrowed, and atresia, in which the valve never formed properly — together occur in about 4,200 U.S. babies each year.
Surgical repairs can restore blood flow, but some children are left with a leaky valve. Over time, that leak can strain and enlarge the right side of the heart, and a replacement becomes necessary.
Here is the problem the new device addresses: conventional replacement valves come in fixed sizes, so children can simply outgrow them. Most are also made from animal tissue, which wears out. Both issues often send a child back to the operating room.
"For children born with congenital heart disease, valve replacement timing has always been a difficult decision—wait too long and you risk harm to the child, but intervene too early and they may need multiple open-heart surgeries as they grow," said Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, in a news release.
How the valve expands
The Autus valve starts small. Surgeons can implant it at about 13 millimeters wide — a size that fits a toddler or preschooler. As the child grows, doctors can widen the valve up to 22 millimeters, close to adult size, using a small balloon threaded through a blood vessel. No open-heart surgery is required for the widening procedure.
The valve's inner flaps, called leaflets, which open and close to regulate blood flow, are made of a synthetic material rather than animal tissue. This is the first FDA-approved valve of any kind to use the material.
What the trial showed
The approval rests on a study of 62 children treated at 12 U.S. hospitals. All of the procedures succeeded, and the study recorded no deaths, no strokes, and no blood clots requiring treatment. Two children who began outgrowing their valves had them widened without surgery.
The FDA cautioned that experience with the expansion procedure remains limited, and longer-term studies are underway. Those follow-up studies will be important for confirming how the valve performs over many years of growth.
"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 University Irving Medical Center in New York City, who served as an investigator in the trial.
A high bar for review
The device went through premarket approval, the FDA's most rigorous review pathway, which applies to the highest-risk medical devices. Before that, it had received Breakthrough Device designation, a program that speeds up review of promising technologies for serious conditions.
For families of children with pulmonary valve disease, the approval offers a practical hope: fewer repeat operations, and a valve that keeps pace with a growing body.
via Medical Xpress (Source)
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