The FDA approved a child’s heart valve a balloon can widen from 13 to 22 millimeters

Thirteen millimeters is the diameter at which the Autus Size-Adjustable Valve goes into a young child’s heart, and 22 millimeters is where a balloon catheter can eventually take it. The FDA approved the device on October 1, 2026, for Edwards Lifesciences, as a pulmonary valve for children born with a narrowed or missing valve between the heart and the lungs.

FDA’s announcement says the valve is “initially implanted as small as approximately 13 millimeters in diameter,” the right size for a toddler or preschool-aged child, and can later be widened as the child grows, “eventually reaching up to 22 millimeters.” The span between those two figures is 9 millimeters of diameter, about a 70 percent increase over the starting size, which is the range a single implanted frame is meant to cover from toddlerhood toward adolescence.

A Pulmonary Valve for Pulmonary Valve Stenosis and Atresia

The device targets two defects, pulmonary valve stenosis and pulmonary valve atresia, which together affect around 4,200 babies in the United States each year, per the FDA’s approval announcement. Valve replacement has been the standard repair, and it carries a built-in problem: a fixed-diameter prosthesis does not grow. As the child does, the valve becomes too small for the heart that surrounds it and has to be swapped for a larger one, each time through a new operation. HospiMedica reported that children with fixed-diameter prosthetic valves typically need replacement every few years.

The approval came through premarket approval, the FDA’s most stringent route for Class III devices, the category of devices that pose the greatest risk. A valve inside a child’s heart falls in that group, so the agency reviewed clinical data from a study in children before allowing it onto the market.

Polymer Leaflets and a Catheter Balloon

The Autus valve departs from the animal-tissue valves common in this surgery. Its leaflets are polymeric, which the FDA says makes it the first valve approved in the United States with leaflets of that material. After surgery, a cardiac catheterization specialist can thread a balloon catheter to the valve and inflate it, stretching the frame to a larger diameter without reopening the chest. Sophie-Charlotte Hofferberth, the inventor of the device, who developed it at Boston Children’s Hospital, told HospiMedica that a child would be expected to recover from an expansion within a few hours.

The idea predates the approval by years. Medical Design & Outsourcing described the design as a two-leaflet valve modeled on the way veins keep blood moving, a departure from the three-leaflet layout of standard prosthetic valves, first implanted in late 2021 and then tested in FDA-approved early studies in children ages 2 to 11 beginning in February 2023. Hofferberth said at the time that a pulmonary valve adjustable for size “could give young patients a bridge through childhood.”

Its developer, Autus Valve Technologies, was acquired by Edwards, which paid $128.9 million for the technology, Cardiovascular Business reported. The same outlet described the first U.S. implant of the valve by Jennifer Romano at C.S. Mott Children’s Hospital in Michigan, a six-year-old patient treated during the FDA review period under a continued-access arrangement. The valve is designed for children from about 18 months to 16 years, according to Michigan Medicine, where Romano called it “a game changer” and said a child may now receive a valve that “could potentially last them a lifetime.”

The 62-Patient Study and What It Found

The FDA’s evidence came from a study of 62 children at 12 U.S. sites. At six months, the first 60 patients showed acceptable blood flow through the valve, with no more than mild leakage. No deaths, blood clots or strokes occurred. Three patients had fractures in the valve frame and two had reduced leaflet movement, none of which caused symptoms, and two patients needed the valve widened, both successfully and without invasive surgery.

The FDA headlined the approval as the first heart valve designed to grow with children, and it attached two further “firsts” in the text: it is the first heart valve designed to expand after surgery to match a child’s growth, and the first pediatric approval under the agency’s Total Product Life Cycle Advisory Program. Acting FDA Commissioner Kyle Diamantas called the approval “a historic turning point,” and Michelle Tarver, director of the agency’s Center for Devices and Radiological Health, is also named in the announcement. The study enrolled 62 children, so each reported event, including the three frame fractures, represents a few percent of the whole group.

The six-month follow-up is short for a device meant to serve a child for years. In the agency’s words, longer-term studies are under way to measure the risks and to confirm that expansion keeps the valve functioning, with the stated goal of cutting down on future surgeries, and the three frame fractures are the number those studies will have to track.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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