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Story summary
- The U.S. Food and Drug Administration approved the Autus Size-Adjustable Valve for children with congenital pulmonary valve disease.
- The valve implants at 13 mm and can be balloon-expanded to 22 mm using synthetic leaflets.
- In a trial of 62 children at 12 U.S. hospitals, all procedures succeeded with no deaths, strokes or clots.
- Two participants later had their valves widened without additional surgery, demonstrating non-surgical expansion works.
