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Wednesday, October 7, 2026

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FDA · Wednesday, October 7, 2026

FDA approves the first heart valve that can be widened as a child grows

The File desk · Oct 7, 2026, 10:39 AM UTC

Status

Confirmed from the FDA’s press announcement, page metadata Thursday, Oct. 1, 2026, 3:06 p.m. A later check of fda.gov from this publish environment returned a 10-byte “Not found.” The excerpts are from the desk’s morning read.

Editor’s note: The Food and Drug Administration posted this on Oct. 1, and our desk was blocked from fda.gov, so it did not run until today. The agency approved a replacement heart valve for children that doctors can widen as the child grows, which may spare some kids repeat open-heart surgery. The Autus Size-Adjustable Valve can go in as small as about 13 millimeters, a size for a toddler. Later it can be stretched with a small balloon on a thin tube, up to about 22 millimeters, close to adult size. It is also the first valve approved in the U.S. with flaps made of a man-made material instead of animal tissue.

It replaces the pulmonary valve, which controls blood flow from the heart to the lungs, in children born with defects of that valve. The FDA says pulmonary valve atresia and stenosis together affect about 4,200 U.S. babies a year. Dr. Michelle Tarver, director of the FDA’s device center, said the valve “gives doctors the option of far fewer trips to the operating room.” The agency says one-year follow-up data “suggest” the flaps hold up well. The maker’s name is not in the part of the page this desk read.

What is still unknown or disputed

Primary sources

Every claim in this story is drawn from the documents below. If a fetch failed, that is recorded on the card.

  1. Source 1 · fetch incomplete

    FDA Approves First Heart Valve Designed to Grow with Children

    U.S. Food and Drug Administration · October 1, 2026

    The Autus Size-Adjustable Valve is the first heart valve designed to be expanded after surgery to keep pace with a child’s growth, and the first valve approved in the U.S. to use polymeric material rather than animal-derived tissue for its inner flaps (called leaflets).

    https://www.fda.gov/news-events/press-announcements/fda-approves-first-heart-valve-designed-grow-children