FDA approves first pediatric heart valve that expands as children grow
read at fda press ↗ApprovalPositive
The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease.
The device is designed to be expanded after surgery, allowing it to grow with the child and potentially reducing the need for multiple open‑heart surgeries.
It is also the first U.S. approved valve to use a polymeric material for its leaflets rather than animal‑derived tissue.
Acting FDA Commissioner Kyle Diamantas called the approval a historic turning point for treating pediatric heart defects.
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This writeup was produced by pharmadog from original reporting by fda press.
Original headline: “FDA Approves First Heart Valve Designed to Grow with Children”
read at fda press ↗960 words · retrieved 1h ago
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