Boston Scientific backs pivotal US clinical trial for new TAVR System.

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  "detected_at": "2026-05-19T10:14:18.587+00:00",
  "company": {
    "name": "Boston Scientific",
    "domain": "bostonscientific.com"
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    "detail": "The investment supports the STAR randomized control clinical trial, which requires FDA approval. This creates a significant need for robust data collection, management, and analytics platforms to ensure a successful Premarket Approval Application.",
    "metrics": {
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    "summary": "Boston Scientific backs pivotal US clinical trial for new TAVR System.",
    "excerpts": "...the Siegel transcatheter aortic valve replacement system (the “TAVR System”), for which it has received investigation device exemption approval from the U.S. Federal Food and Drug Administration (“FDA”) to conduct the STAR (Siegel Transcatheter Aortic Valve Replacement Trial) randomized control clinical trial in the United States designed to achieve a Premarket Approval Application for the TAVR System.",
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    "source_url": "https://www.sec.gov/Archives/edgar/data/885725/000088572526000041/bsx-20260518.htm",
    "filing_date": "2026-05-18",
    "filing_year": 2026,
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    "regions_mentioned": [
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    "vendors_mentioned": [
      "MiRus LLC"
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