Menu

  • Evolut™ built for a lifetime of care
  • Durability clinical data
  • Lifetime management options
  • Bicuspid valves
  • Get in touch

    • Medtronic’s latest innovation and CE marked indication offer a spectrum of options for patient lifetime management, such as coronary access and redo-TAV.

    Evolut™ FX+

    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

    1 Performance as compared to Evolut ™ PRO+ and FX systems 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. Benchtop computational model may not be indicative of clinical performance. Evolut ™ FX+ Test Report: DO1106198 Rev. A.

    Technique matters

    Cusp overlap technique with an optimized care pathway shows low permanent pacemaker implantation (PPI) rates and optimal alignment for lifetime management with the Evolut™ FX system.1

    Key steps from the Optimize Pro FX addendum

    1. Conduct initial deployment in the cusp overlap projection and conduct aortogram to obtain the estimated implant depth at the NCC
    2. Begin deployment with the marker band positioned at mid-pigtail or higher
    3. Assess depth in cusp overlap view at 80% deployment

    Excellent commissure and coronary alignment validated by post-TAVI CT1

    87% favorable commissure alignment

    > 92% no severe coronary misalignment

    Excellent clinical outcomes and hemodynamic performance1

    Through one year

    7.5% all-cause mortality or stroke
    99% ≤ mild (0.8% moderate) paravalvular leak (PVL)
    2.2 cm2 EOA 
    8.1 mmHg

    1 Gada H et al., Thirty Day and One Year Outcomes from the Optimize PRO TAVR Evolut FX Addendum Study, JACC: Cardiovascular Interventions, 2025, ISSN 1936-8798

    Longevity after surgical aortic valve replacement

    Stratification by age and surgical risk groups

    For most TAVI patients, one valve is all they will need

    Lifetime management of patients undergoing AVR1

    #

    1 Martinsson A, et al. J Am Coll Cardiol. 2021;78:2147-2157.

    Reintervention after index Evolut™

    CT Case planning algorithm1 and important concepts2,3

    #

    Acronym

    NSP: Neoskirt Plane

    CRP: Coronary Risk Plane†

    STJ: Sinotubular Junction Plane

     

    NSP: Neoskirt Plane

    CRP: Coronary Risk Plane†

    STJ: Sinotubular Junction Plane

    #

    †  Coronary risk plane (CRP): The inferior portion of each coronary ostia

    ‡ The relationship between implant depth of a seco26nd TAV and neoskirt height has not been fully established, particularly in the context of leaflet overhang. Clinical evaluation should be guided by the judgment of the implanting physician

    § Refer to the provided neoskirt width values in the tav-in-tav bifold to evaluate clearance around neoskirt for coronary perfusion and access

    1 Tarantini G, Delgado V, de Backer O, et al. Redo-Transcatheter Aortic Valve Implantation Using the SAPIEN 3™*/Ultra Transcatheter Heart  

    Valves-Expert Consensus on Procedural Planning and Techniques.  Am J Cardiol. April 1, 2023;192:228–244.

    2 Grubb KJ, Shekiladze N, Spencer J, et al. Feasibility of redo-TAVI in self-expanding Evolut™ valves: a CT analysis from the Evolut™ Low Risk Trial substudy. EuroIntervention. July 17, 2023;19(4):e330–e339.

    3 Tang GHL, Spencer J, Rogers T, et al. Feasibility of Coronary Access Following Redo-TAVR for Evolut™ F27ailure: A Computed Tomography Simulation Study. November 2023;16(11):e013238.

    Evolut™ design differentiation is at the root of the valve performance and durability that has been proven in randomized clinical trials.1, 2

    Explore Evolut™ durability clinical data

    1 Herrmann H. Two-Year Outcomes of the Five-Year SMART Trial; presented at CRT 2025.

    2 Forrest JK, et al. J Am Coll Cardiol. 2025:S0735-1097(25)05335-5.