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News
The FDA approved the Autus Size-Adjustable Valve — the first surgically implanted pulmonary valve designed to expand as a child grows. Made by Edwards Lifesciences, the device could significantly reduce the number of open-heart surgeries kids with congenital pulmonary valve disease need over their lifetimes. It's also the first FDA-approved heart valve with synthetic (polymeric) leaflets instead of animal-derived tissue.
For children born with congenital pulmonary valve disease, the treatment dilemma has always been a tough one: intervene early and risk multiple repeat surgeries as the child grows, or wait and risk harm. The FDA just approved a device that could change that calculus entirely. The Autus Size-Adjustable Valve, made by Edwards Lifesciences, is the first surgically implanted pulmonary valve designed to be expanded after the initial procedure — keeping pace with a child's growth via transcatheter balloon dilation, without requiring a return to the operating room.
The valve can be implanted as small as ~13 mm in diameter and expanded up to 22 mm. It's also a first in another way: its inner leaflets are made from expanded polytetrafluoroethylene (ePTFE), a synthetic polymer — marking the first FDA-approved heart valve to use polymeric rather than animal-derived tissue.
By the Numbers:
Why it matters: Repeat open-heart surgeries carry serious risks and take a significant toll on children and families. A valve that grows with the patient could mean fewer surgeries, better quality of life, and a new standard of care for pediatric congenital heart disease. Longer-term follow-up studies are ongoing through 10 years.
