CLINICAL EVIDENCE — HEMODYNAMICS TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)

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:

• Newest Generation Evolut™ PRO Study
• SURTAVI (Intermediate Risk) Trial
• ADVANCE Post-Market Study

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
  

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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

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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

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