For children born with a faulty pulmonary valve, growing up has often meant going back to the operating room: a replacement valve that fits a toddler is simply too small for a teenager. On 1 October 2026, the U.S. Food and Drug Administration approved the first heart valve designed to grow with its patient.
Key facts
The Autus Size-Adjustable Valve, approved for Edwards Lifesciences, can be implanted as small as about 13 millimeters and later widened to up to 22 millimeters.
Widening is done with a balloon catheter, a thin tube guided through a blood vessel, instead of open-heart surgery.
In the study behind the approval, 62 children were treated at 12 U.S. hospitals. Every procedure was successful, with no deaths, strokes or blood clots requiring treatment.
Two children whose valves needed to be enlarged were expanded without surgery.
Why it matters
About 4,200 babies are born in the United States each year with pulmonary valve atresia or stenosis, according to the FDA. A valve that keeps pace with a growing body could mean fewer major operations, less time in hospital and more of an ordinary childhood.
Worth noting
The results so far cover months, not decades. Three valve frames fractured and two valves showed reduced leaflet movement, none of which caused symptoms, and longer-term studies are under way.