FDA Approves Transcatheter Tricuspid Valve Repair System

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  "signal_type": "news",
  "signal_subtype": "launches",
  "detected_at": "2026-10-23T16:59:31+00:00",
  "company": {
    "name": "Edwards Lifesciences",
    "domain": "edwards.com"
  },
  "data": {
    "url": "https://www.dicardiology.com/content/fda-approves-transcatheter-tricuspid-valve-repair-system",
    "title": "FDA Approves Transcatheter Tricuspid Valve Repair System - www.dicardiology.com",
    "excerpt": "Oct. 21, 2026 - Edwards Lifesciences Corp. recently 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. “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. “With the addition of the PASCAL tricuspid valve repair system to our portfolio of tricuspid transcatheter therapies, Edwards is able to support the treatment of a broader group of tricuspid patients, empowering clinicians to select the most appropriate therapy to treat more patients and support optimal...",
    "product": "PASCAL Ace with Capture Clarity",
    "summary": "Edwards Lifesciences received FDA approval for the PASCAL Ace with Capture Clarity system for use in degenerative mitral TEER procedures.",
    "location": "United States",
    "planning": false,
    "image_url": "http://www.dicardiology.com/sites/default/files/Edwards%20Lifesciences%20PASCAL_Tricuspid.jpg",
    "confidence": 0.95,
    "product_data": {
      "name": "PASCAL Ace with Capture Clarity",
      "full_text": "PASCAL Ace with Capture Clarity system for use in degenerative mitral TEER procedures",
      "fuzzy_match": false
    },
    "product_tags": [
      "general_technology",
      "medical"
    ],
    "published_at": "2026-10-23T16:59:31Z",
    "location_data": [
      {
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "article_sentence": "The company also shared that the FDA has approved the PASCAL Ace with Capture Clarity system for use in degenerative mitral TEER procedures (M-TEER)."
  }
}

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