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CLINICAL EVIDENCE — PROVEN PLATFORM TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)

Indications, Safety, and Warnings   Indications, Safety, and Warnings 

The Evolut TAVI System Proven Platform

The EvolutTM TAVI System is built on a proven platform that provides industry-leading hemodynamics, advanced sealing and a low-profile delivery. The CoreValveTM TAVI platform is the only TAVI platform currently on the market that demonstrates significantly better outcomes in all-cause mortality or stroke over surgery in high-risk patient at 3 years.1

COREVALVE U.S. PIVOTAL HIGH RISK TRIAL2

The CoreValve U.S. Pivotal High Risk Trial is a prospective, randomized, multicenter, noninferiority trial to compare the safety and efficacy of the Medtronic CoreValve system to SAVR in patients with symptomatic severe aortic stenosis at increased surgical risk.

  • Study Status/Duration: 3-year outcomes reported/5-year follow-up
  • Sample Size: N = 795 (TAVI = 391, SAVR = 359)
  • Devices: CoreValve TAV
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Graph showing CoreValve all-cause mortality or stroke as compared to SAVR
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The Medtronic TAVI supra-annular valve design contributes to industry-leading hemodynamics.

SEE INDUSTRY-LEADING HEMODYNAMIC DATA

TAVI CLINICAL GUIDELINES

Find here the latest ESC/EACTS Valve Heart Disease Guidelines.

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1

Deeb, et al. (2015) presentation

2

Deeb GM, Reardon MJ, Chetcuti S, et al. 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. June 7, 2016;67(22):2565-2574.