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CLINICAL EVIDENCE — HEMODYNAMICS TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)

   Indications, Safety, and Warnings

Clinical Evidence Demonstrates Industry-Leading Hemodynamics

The Medtronic transcatheter aortic valve with a self-expanding, supra-annular design delivers industry-leading hemodynamics. See the recently released clinical evidence on our newest generation TAVI device as well as longer-term hemodynamic performance out to 5 years on this proven platform:

Evolut Pro 29mm

Newest Generation Evolut PRO Study1

The Evolut PRO Study is a prospective, multicenter, non-randomized single-arm study. Primary safety endpoints were all-cause mortality and disabling stroke at 30 days. Primary efficacy endpoint was percentage of patients with none or trace aortic regurgitation at 30 days.

  • Study Status/Duration: 1 year outcomes reported/5-year follow-up
  • Sample Size: N = 60
  • Device: Evolut PRO TAV
Download Study Results

Evolut Pro Valve Performance
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SURTAVI (Intermediate Risk) Trial2

The SURTAVI Clinical Trial is a prospective, multinational, randomized clinical trial evaluating the CoreValve and Evolut R systems versus surgery in patients with symptomatic severe aortic stenosis at intermediate surgical risk.

  • Study Status/Duration: 1-year full Kaplan-Meier and 2-year Bayesian outcomes reported/10-year follow-up
  • Sample Size: N = 864 TAVI, 796 SAVR
  • Devices: CoreValve 84% / Evolut R 16% TAVs
SEE DATA

Surtavi Hemodynamics Graph
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ADVANCE Post-Market Study3

The CoreValve ADVANCE Study is a multicenter, prospective, single-arm observational study to evaluate safety and performance of the CoreValve system in a routine hospital setting.

  • Study Status/Duration: 5-year outcomes reported/5-year follow-up
  • Sample Size: N = 1,015
  • Devices: CoreValve, TAV
SEE STUDY DATA

CoreValve Advance 5-years

CoreValve Hemodynamics Graph

CoreValve Hemodynamics Graph
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1

Williams, as presented at 2018 ACC

2

Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. April 6, 2017;376(14):1321-1331.

3

Gerckens U, Tamburino C, Bleiziffer S, et al. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J. September 21, 2017;38(36):2729-2738.