Your browser is out of date
With an updated browser, you will have a better Medtronic website experience. Update my browser now.
Predictability affects accuracy. Procedural approaches like the cusp overlap technique improve commissure alignment and amplify the strengths of the Evolut™ platform design by enabling more predictable and reproducible outcomes.
Using the radiopaque markers of the Evolut FX system, and with the improved procedural technique, over 95% commissure alignment was achieved.
*Commissure alignment is defined as aligned/mild misalignment 0–30°.
Tang, et al., found the commissural alignment technique allows for more accurate placement and orienting the hat marker at the outer curve during deployment reduces incidence of severe coronary overlap.3
Alignment of the THV commissure to the native valve commissure
Cusp overlap technique with an optimized care pathway, as shown in the Optimize PRO study, provides excellent clinical outcomes.†4
Paravalvular leak (main cohort)
Optimize PRO study4
Devices used: 91.5% Evolut™ PRO+/8.0% Evolut™ PRO.
†This is an interim analysis of 504 patients (104 roll-in and 400 main cohort). At the conclusion of the study, more than 650 patients will have been evaluated.
‡One patient with mild-moderate PVL.
Data from the STS/ACC TVT Registry™* shows a consistent, downward trend of permanent pacemaker rates with the latest figure of 8.8% in Q2 of 2021.
% Evolut patients with in-hospital
permanent pacemaker implantation
(excluding baseline PPI/ICD)
These rates include TAV-in-SAV and TAV-in-TAV treated patients.
Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
Tang GHL. First-in-Human Multicentre Experience of TAVI with the Supra-annular Self-Expanding Evolut FX System. Presented at PCR London Valves 2022; November 28, 2022; London, England.
Tang GHL, Amat-Santos IJ, De Backer O, et al. Rationale, Definitions, Techniques, and Outcomes of Commissural Alignment in TAVR: From the ALIGN-TAVR Consortium. JACC Cardiovasc Interv. August 8, 2022;15(15):1497-1518.
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. February 2022;99(3):924-931.
Grubb K. Impact of a standardized TAVI technique and care pathway in the Optimize PRO study. Presented at EuroPCR 2022; May 17, 2022. Paris, France.
Harvey JE. Decreasing Permanent Pacemaker Implantation Rates in the STS/ACC TVT Registry with a Supra-annular Self-expanding Transcatheter Heart Valve. Presented at TVT 2022; June 9, 2022; Chicago, IL.