The Autus Size-Adjustable Valve, approved by the U.S. Food and Drug Administration on October 1, 2026, is implanted in a child at about 13 millimeters and can later be widened to up to 22 millimeters with a balloon catheter. That range runs from a valve sized for a toddler or preschooler to roughly the size of an adult pulmonary valve.
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Until now, a child born with a defective pulmonary valve has often outgrown a replacement and returned to the operating room for another. The new valve is built to be stretched inside the chest instead.
From 13 millimeters to 22 inside a growing heart
The FDA’s approval announcement says the valve is the first heart valve designed to be expanded after implantation to keep pace with a child’s growth. It is surgically placed in the pulmonary position, where it controls blood flow from the right side of the heart to the lungs. As the child grows, a small inflatable balloon catheter can widen it from about 13 millimeters to as much as about 22 millimeters, so a repeat open-heart operation is not the only way to enlarge it.
Edwards Lifesciences, the approval holder, describes the same design as a surgical pulmonary valve that can be expanded through a minimally invasive transcatheter procedure. Autus Valve Technologies Inc. is listed as the developer. In Edwards’ announcement of the approval, Dr. Emile Bacha, surgeon-in-chief at NewYork-Presbyterian/Columbia University Irving Medical Center and an investigator in the pivotal study, said the valve gives heart teams “a new way to think about long-term care planning.”
Polymer leaflets instead of animal tissue
The leaflets, the flaps that open and close with each heartbeat, are made of a polymeric material rather than animal-derived tissue. The FDA says it is the first approved valve to use polymeric leaflets for any indication. Animal tissue tends to harden and break down faster in children, often forcing earlier repeat surgery, and early one-year follow-up suggests the synthetic leaflets hold up well.
The agency’s leadership framed the approval as a turning point. Acting FDA Commissioner Kyle Diamantas called it “a historic turning point” for children who have faced limited surgical options. Michelle Tarver, director of the agency’s Center for Devices and Radiological Health, said the valve gives doctors “the option of far fewer trips to the operating room,” which may improve quality of life for children and their families.
About 4,200 babies a year and the trial behind the approval
The conditions involved are pulmonary valve stenosis, a narrowed valve, and pulmonary valve atresia, a valve that fails to form normally. According to the CDC, as the FDA cites it, those two conditions together affect around 4,200 U.S. babies each year, and the FDA page links the agency’s birth defects data brief for 2018 to 2022. Congenital heart defects as a group affect about 1 in 100 U.S. births. That is the number of births with the conditions, not the number who will receive this valve.
Some children are left with pulmonary regurgitation, blood leaking backward through the valve, which over time can weaken or enlarge the right ventricle and eventually require valve replacement. That cycle of replacement is the burden the adjustable design is meant to reduce.
The approval rests on a trial of 62 pediatric patients at 12 U.S. sites. In the first 60 patients, six-month results showed blood flow on the right side of the heart within acceptable limits and leakage no worse than mild. All procedures succeeded, with no deaths, no clot-related events needing treatment and no strokes. Three patients had a fracture in the valve frame and two had reduced movement of one leaflet, though none of those findings caused symptoms.
The growth feature has the thinnest evidence. Valve performance began declining in two patients who were outgrowing their valves, and both were expanded successfully without an invasive surgical procedure. The FDA notes that this experience is limited, and longer-term studies are under way to show that expansion can maintain a functioning valve and reduce the number of surgeries. Edwards says patients will be followed for 10 years.
Several practical questions are not answered in the sources. Neither the FDA announcement nor Edwards’ release says when the valve will reach hospitals, how many centers will offer it, or what it will cost, and Edwards does not give the number of patients in its pivotal study. Families asking about eligibility would need to raise it with a pediatric cardiology team, since the approval covers children with congenital pulmonary valve disease and not every child with a heart defect.
Premarket approval and the FDA’s expedited programs
The valve was approved through premarket approval, the agency’s most stringent pathway, used for Class 3 devices that generally pose the highest risk. It had earlier received Breakthrough Device designation, described on the FDA’s Breakthrough Devices Program page, and it is the first pediatric approval to come out of the Total Product Life Cycle Advisory Program, a voluntary program meant to speed development of safe, effective devices.
This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.
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