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Anteris Launches Global Trial After FDA Nod for DurAVR Heart Valve

9:16am on Monday 3rd of November, 2025 AEDT Healthcare
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Anteris Launches Global Trial After FDA Nod for DurAVR Heart Valve

9:16am on Monday 3rd of November, 2025 AEDT
Key Points
  • FDA approval granted to start PARADIGM global pivotal trial
  • Trial to enroll ~1000 patients across US, Europe, and Canada
  • DurAVR THV compared head-to-head with commercial TAVR devices
  • Primary endpoint includes mortality, stroke, and cardiovascular hospitalization
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