FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease

{
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  "signal_type": "news",
  "signal_subtype": "launches",
  "detected_at": "2026-10-21T13:05:20+00:00",
  "company": {
    "name": "Edwards Lifesciences",
    "domain": "edwards.com"
  },
  "data": {
    "url": "https://www.bastillepost.com/global/article/6275909-fda-approval-of-edwards-lifesciences-pascal-precision-system-opens-new-treatment-pathway-for-patients-with-tricuspid-valve-disease",
    "title": "FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease - 巴士的報",
    "ticker": "NYSE:EW",
    "excerpt": "Business Business FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease 2026-10-21 21:05 Last Updated At：21:11 Facebook Weibo IRVINE, Calif.--(BUSINESS WIRE)--Oct 21, 2026-- Edwards Lifesciences Corporation (NYSE: EW) today announced that the U.S. Food and Drug Administration (FDA) has approved its PASCAL Precision system for tricuspid valve repair. The system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy who are deemed at intermediate or greater risk for surgery and deemed appropriate for transcatheter edge-to-edge tricuspid valve repair (T-TEER) by a multidisciplinary heart team. With this approval, Edwards is now the only company to provide a portfolio of repair and replacement transcatheter therapies for the mitral and tricuspid valves in the United States. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021489439/en/ “The PASCAL system has been a valuable option for treating patients suffering with debilitating symptoms from degenerative mitral regurgitation in the US for several years, and we’re pleased that this differentiated therapy is now available to tricuspid patients in the US,” said Daveen Chopra, Edwards’...",
    "product": "PASCAL Precision",
    "summary": "Edwards Lifesciences received FDA approval making its PASCAL Precision system available for tricuspid valve repair in the US.",
    "location": "Irvine, California, United States",
    "planning": false,
    "image_url": "https://image.bastillepost.com/640x/wp-content/uploads/global/2026/10/88407cc67fae4c93a00b3a6f3b1846bb_PASCAL_Tricuspid_FB.jpg",
    "confidence": 0.95,
    "product_data": {
      "name": "PASCAL Precision",
      "full_text": "PASCAL Precision system for tricuspid valve repair",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical",
      "general_technology"
    ],
    "published_at": "2026-10-21T13:05:20Z",
    "location_data": [
      {
        "city": "Irvine",
        "state": "California",
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "effective_date": "2026-10-21",
    "article_sentence": "“The PASCAL system has been a valuable option for treating patients suffering with debilitating symptoms from degenerative mitral regurgitation in the US for several years, and we’re pleased that this differentiated therapy is now available to tricuspid patients in the US,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies."
  }
}

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