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Medtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

  • On March 30, 2025, Medtronic plc announced late-breaking five-year data from the Evolut Low Risk Trial, presented at the American College of Cardiology's Annual Scientific Session & Expo and published in JACC, demonstrating the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients with a predicted 30-day mortality risk of less than 3%.
  • The Evolut Low Risk Trial was a randomized study involving 1,414 patients, with 730 receiving TAVR using a Medtronic Evolut R, PRO, or CoreValve and 684 undergoing surgery.
  • At five years, the Evolut TAVR system demonstrated lasting clinical outcomes comparable to surgery, with a numerically lower rate of all-cause mortality or disabling stroke, and showed strong valve performance with significantly larger effective orifice areas and lower mean gradients compared to surgery.
  • According to Kendra J. Grubb, vice president and chief medical officer of Structural Heart at Medtronic, "At five years, Evolut has demonstrated lasting clinical outcomes comparable to surgery and a trend toward reduced cardiovascular mortality,", while Michael J. Reardon, M.D., principal investigator of the trial, stated that the lower mortality risk and strong valve performance is meaningful for clinicians.
  • The Evolut Low Risk Trial data and SMART trial results, according to Medtronic, support Evolut TAVR as a safe and durable alternative to surgery for patients with severe aortic stenosis, regardless of surgical risk, reinforcing the importance of personalized treatment decisions, although an editorial by Tsuyoshi Kaneko, MD, highlights the need for 10-year data to fully understand long-term safety and effectiveness.
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Medtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

GALWAY, Ireland and CHICAGO, March 30, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic…

·Georgia, United States
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The Health Standard broke the news in Missouri, United States on Sunday, March 30, 2025.
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