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Evolut™ FX+ TAVI System

 

Built for durability
Designed for access

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Alert Indications, Safety, and Warnings

Overview

  • The durability data you’d expect.1
  • Now with windows for coronary access when you need it.2

Design goals

Built for durability

1. Outflow: The Evolut™ FX+ TAV is designed with the same structural strength at the outflow as the Evolut™ FX valve.1

2. Inflow: The Evolut™ FX+ TAV is designed with the same radial force at the inflow as the Evolut™ FX valve.1

Built on the original CoreValve™ platform, Evolut™ FX+ is engineered with specific design elements to promote sustained valve performance with consistently large effective orifice area (EOAs) and low gradients over time. Evolut™ FX+ also uses the same Evolut™ FX delivery system designed for precision, flexibility, and control.

Designed for access

3. Waist: The Evolut™ FX+ TAV is designed with three windows that are 4x larger to enable lifetime management solutions such as coronary access.2

Blue outline of Evolut™ FX+ TAV with green highlights and callouts encircled in blue

Commissure alignment 

Commissural alignment facilitates future coronary access.3

Tang, et al., found the commissural alignment technique allows for more accurate placement and orienting the hat marker at the outer core during deployment reduces incidence of severe coronary overlap.4

Procedural vision

Using the valve radiopaque markers sustained from the Evolut™ FX system features, and following Evolut™ procedural technique, commissure alignment can be achieved.5

The Evolut™ FX+ windows are predicted to be aligned to the coronary ostias when following commissure alignment techniques.2

Evolut™ FX+ transcatheter aortic valve and delivery catheter with green highlighted areas

Post-TAVI coronary access

Commissural alignment facilitates future coronary access.3

Tang, et al., found the commissural alignment technique allows for more accurate placement and orienting the hat marker at the outer core during deployment reduces incidence of severe coronary overlap.4

Procedural vision

Using the valve radiopaque markers sustained from the Evolut™ FX system features, and following Evolut™ procedural technique, commissure alignment can be achieved.5

The Evolut™ FX+ windows are predicted to be aligned to the coronary ostias when following commissure alignment techniques.2

Evolut™ FX+ transcatheter aortic valve and delivery catheter with green highlighted areas

Clinical data

Expand All

SMART Trial 1-year results

SMART Trial 1-year results6

Evolut™ TAVI delivers superior valve performance† versus SAPIEN™* platform in small annulus patients with excellent early patient outcomes at 1 year.6

4x less

bioprosthetic valve dysfunction (BVD)† at 1 year vs. SAPIEN™* platform.‡ p < 0.001

Evolut™ TAVI: 9.4%
SAPIEN™* TAVI: 41.6%

Sample size

N = 716 total
N = 355 Evolut™ TAVI
N= 361 SAPIEN™* TAVI

Devices

Evolut™ PRO+ 78.0%
Evolut™ PRO 17.1%
Evolut™ FX 4.3%
Evolut™ R 0.6%

SAPIEN™* 3 Ultra 80.8%
SAPIEN™* 3 19.2%

Clinical outcome composite
All-cause mortality, disabling stroke, or heart failure rehospitalization at 1 year

Difference, -1.2% (90% CI -4.9%, 2.5%), p < 0.001 for noninferiority Hazard ratio, 0.90 (95% CI 0.56–1.43)

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† Valve performance as defined as freedom from BVD at 12 months. BVD is a composite including any of the following: hemodynamic structural valve dysfunction (mean gradient ≥ 20 mmHg), non-structural valve dysfunction (severe PPM or ≥ moderate aortic regurgitation), thrombosis, endocarditis, and aortic valve reintervention.

‡ In patients with small annuli (area ≤ 430 mm2) in all-comers trial, consisting of majority low surgical risk participants (52.1%).

Evolut™ Low Risk Trial

The best TAVI vs. SAVR durability data yet

Contact Us to Learn More

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References

1

Performance as compared to Evolut™ PRO+ and FX system in bench testing. Bench testing may not be indicative of clinical performance. Medtronic data on file. Evolut™ FX+ Test Reports: D01073856, D01095344, D01084996.

2

Medtronic computational data model on file compared to the Evolut™ platform. Bench top computational model may not be indicative of clinical performance. Evolut™ FX+ Test Report: DO1106198 Rev. A.

3

Tarantini G, Fovino LN, Scotti A, et al. Coronary access after transcatheter aortic valve replacement with commissural alignment: The ALIGN-ACCESS Study. Circ Cardiovasc Interv. 2022;15(2):e011045. doi: 10.1161/CIRCINTERVENTIONS.121.011045.

4

Tang GHL, Sengupta A, Alexis SL, et al. Conventional versus modified delivery system technique in commissural alignment from the Evolut low-risk CT substudy. Catheter Cardiovasc Interv. 2022;99(3):924-931. doi: 10.1002/ccd.29973.

5

Attizzani G, Gabasha S, Filby S. TCT-248 Assessment of coronary cannulation, commissure and coronary alignment post-TAVR with the new supra-annular, self-expanding Evolut™ FX system. J Am Coll Cardiol. 2023;82(17):B97. doi:10.1016/j.jacc.2023.09.255

6

Herrmann HC, Mehran R, Blackman DJ, et al. Self-expanding or balloon-expandable TAVR in patients with a small aortic Annulus. N Engl J Med. Published online April 7, 2024. doi: 10.1056/NEJMoa2312573.

7

Reardon M, et al. Transcatheter versus surgical aortic valve replacement in aortic stenosis patients at low surgical risk: 4-year outcomes from the Evolut low risk trial. Presented at TCT; 2023.

8

Reardon 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.

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