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congenital-heart-disease

Every record this desk has filed under congenital-heart-disease, newest first, each with the number of sources it can still show you.

1 recordOctober 1, 2026All topics
  1. News1 receipt3 min

    FDA approved the first heart valve designed to grow with children, a surgically implanted pulmonary valve for pediatric patients with congenital pulmonary valve disease.

    The FDA approved the Autus Size-Adjustable Valve on October 1 for children with congenital pulmonary valve disease. It is the first heart valve designed to be widened by balloon catheter as a child grows, from about 13 up to 22 millimeters, and the first valve approved in the U.S. with synthetic leaflets instead of animal tissue. The approval rests on a 62-patient study at 12 U.S. sites; the FDA says it may reduce, not eliminate, repeat open-heart surgeries, and the announcement does not say when the valve becomes available.

    Also filed underhealthpediatricsmedical-devicesfda-approval

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