Edwards earns FDA approval for first-of-its-kind size-adjustable pediatric heart valve

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  "detected_at": "2026-10-01T21:42:18+00:00",
  "company": {
    "name": "Edwards Lifesciences",
    "domain": "edwards.com"
  },
  "data": {
    "url": "https://www.massdevice.com/edwards-earns-fda-approval-for-first-of-its-kind-autus-size-adjustable-pediatric-heart-valve/",
    "title": "Edwards earns FDA approval for first-of-its-kind size-adjustable pediatric heart valve - MassDevice",
    "excerpt": "The first-of-its-kind valve is designed to expand as the child grows, reducing the need for repeat open-heart surgeries. It’s also the first artificial heart valve approved in the United States with polymeric material leaflets rather than animal-derived tissue leaflets. “For decades, Edwards has worked to address the needs of structural heart patients with complex conditions, Edwards Lifesciences CEO Bernard Zovighian said in the announcement. “The Autus valve represents a meaningful advancement for children who have historically had limited treatment options. Our commitment extends beyond innovation to generating clinical evidence and collaborating with physicians, medical societies and patient groups to help address the evolving needs of patients with congenital heart disease.” Related: This Edwards innovation may have solved the leading cause of tissue valve failure The Autus valve can be initially implanted as small as 13 mm in diameter, the appropriate-sized valve for a toddler or preschool-age patient, FDA said. Over time, valve expansion is performed through a minimally invasive transcatheter procedure that widens the valve using a balloon catheter. The Autus valve can reach a maximum size of 22 mm, comparable to an adult-sized pulmonary valve. Traditional animal-derived tissue leaflets harden and break down faster in children, FDA said, often causing earlier repeat...",
    "product": "Autus valve",
    "summary": "Edwards Lifesciences has received FDA approval for its Autus valve, a first-of-its-kind size-adjustable pediatric heart valve designed to expand as a child grows.",
    "location": "United States",
    "planning": false,
    "image_url": "https://wtwh-marketing.s3.amazonaws.com/wp-content/uploads/massdevice/2026/10/01173356/Edwards-Autus-valve.jpg",
    "confidence": 1,
    "product_data": {
      "name": "Autus valve",
      "full_text": "first-of-its-kind size-adjustable pediatric heart valve",
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      "medical"
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    "published_at": "2026-10-01T21:42:18Z",
    "location_data": [
      {
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "article_sentence": "The first-of-its-kind valve is designed to expand as the child grows, reducing the need for repeat open-heart surgeries."
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