People who know, think Evolut First.

CoreValve™/Evolut™ is the first and only platform to outperform surgery in valve durability at five years.1

Alert Indications, Safety, and Warnings

The best TAVR vs. SAVR durability data yet.

The CoreValve™/Evolut™ TAVR system is the only TAVR platform to demonstrate a lower rate of SVD compared to SAVR at five years.

4.38% Surgery RCT (N = 971)
2.20% CoreValve™/Evolut™ RCT (N = 1,128)

Devices used:
88.5% CoreValve™ TAV
11.5% Evolut™ R

Explore durability data

CoreValve™ and Evolut™ pooled analysis:

5-year SVD adjusted for competing risk of mortality†1

Medtronic TAVR platforms demonstrated significantly lower rates of structural valve deterioration (SVD)‡ vs. SAVR at five years.

Click to enlarge graph

TAVR risks may include, but are not limited to: death, stroke, damage to the arteries, bleeding, and the need for a permanent pacemaker.

Supra-annular design benefits.

Valve durability for supra-annular, self-expandable TAV was found to be statistically better at five years vs. both SAVR and balloon-expandable TAV.

At five years, supra-annular, self-expandable (SE) valves demonstrated:

  • Lowest risk of structural valve deterioration (SVD) compared with balloon-expandable (BE) valves and SAVR
  • Significantly stronger hemodynamics with larger EOAs and lower mean gradients versus BE valves

Study design

  • Meta-analysis
  • 10 randomized controlled trials
  • 9,388 patients
  • Follow-up 1 to 6 years
  • Multiple devices§

5-year meta-analysis2

Structural valve deteriorationll

  

Only SE performs better than SAVR.
Comparison: others versus SAVR
(random effects model)

Chart showing structural valve deterioration with self-expandable TAV versus SAVR at five years

SE performs better than SAVR and BE.
Comparison: others versus self-expandable
(random effects model)

Chart showing structural valve deterioration with self-expandable TAV versus SAVR and balloon-expandable TAV at five years
Download full meta-analysis

Longevity data that may surprise you.

Data show longevity after SAVR based on stratification by age and surgical risk groups.

  • High risk/80 years at AVR: median survival < 6 years
  • Intermediate risk/75 years at AVR: median survival 7–8 years
  • Low risk/70 years at AVR: median survival 12–13 years
  • Low risk/75 years at AVR: median survival ~10 years
  • Low risk/80 years at AVR: median survival 8–10 years

Life expectancy of patients undergoing AVR3

Longevity chart after surgical aortic valve replacement (SAVR) based on stratification by age and surgical risk groups
Click to enlarge chart

Durability starts with design.

Evolut Pro transcatheter aortic valve implanted in the aorta

Built on a proven foundation. 

With its supra-annular, self-expanding valve frame, Evolut™ TAVR is built on the original CoreValve™ platform, which has consistently shown strong EOAs and low gradients over time.

How did we design for durability? 

More surface 
Taller leaflet mounting allows for a greater distance between the commissure and the edge of the leaflet, distributing stress over a greater distance.

More height 
By decoupling the native annular plane, where the sealing occurs, from the working portion of the prosthetic leaflets, you can facilitate circularity and maximize leaflet coaptation.

More room 
The tall valve keeps the working portion above and unconstrained by the native annulus, allowing for a large effective orifice area.

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*

™Third-party brands are trademarks of their respective owners.

†

In pooled analysis of intermediate- and high-risk patients. Devices used: CoreValve™ 88.5%/Evolut™ R 11.5%.

‡

Structural valve deterioration (SVD) was defined as an increase in mean gradient ≥ 10 mm Hg over five years with a mean gradient ≥ 20 mm Hg at last echo OR new onset/increase of central AR of ≥ moderate in severity.

§

CoreValve™, Evolut™ R, Evolut™ PRO, SAPIEN™*, SAPIEN 3, SAPIEN XT, and ACURATE neo™*.

||

Based on the longest available follow-up for each of the 10 studies used for this meta-analysis. SVD was defined by the respective authors of each paper.

References

1

Reardon MJ, et al. 5-Year Incidence, Timing and Predictors of Structural Valve Deterioration of Transcatheter and Surgical Aortic Bioprostheses: Insights from the CoreValve US Pivotal and SURTAVI Trials. Presented at ACC 2022.​ Updated data on file.

2

Ueyama H, Kuno T, Takagi H, et al. Meta-Analysis Comparing Valve Durability Among Different Transcatheter and Surgical Aortic Valve Bioprosthesis. Am J Cardiol. November 1, 2021;158:104-111.

3

Martinsson A, Nielsen SJ, Milojevic M, et al. Life Expectancy After Surgical Aortic Valve Replacement. J Am Coll Cardiol. November 30, 2021;78(22):2147-2157.