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Alert Indications, Safety, and Warnings

Predictability is your superpower.

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.

Hear your colleagues discuss the importance of predictability in their procedures.

View the cusp overlap technique in this short animation.

Accuracy when it matters most.

Using the radiopaque markers of the Evolut FX system, and with the improved procedural technique, over 95% commissure alignment was achieved.



commissure alignment*1

Retrospective multicenter experience using Evolut FX TAVR system1

Decorative element
  • 168 patients
  • Mean age 80 ± 8 years
  • 53.6% females
Decorative element
  • 85.7% right transfemoral approach
Decorative element
  • Commissure alignment was evaluated on fluoroscopy in cusp overlap per Tang et al. JACC Intv 2022 ALIGN-TAVR review2

*Commissure alignment is defined as aligned/mild misalignment 0–30°.

Predictability drives precision.

Visualize the accuracy.

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

Illustration showing the native valve of an Evolut TAV system

Native valve

Illustration showing the commissure alignment of an Evolut TAV system

Commissure alignment

Outcomes matter.

Cusp overlap technique with an optimized care pathway, as shown in the Optimize PRO study, provides excellent clinical outcomes.†4

  1. Single-digit pacemaker rate: 9.8% PPI rate at 30 days
  2. Low rates of PVL: 0% moderate/severe PVL at discharge
  3. One day median discharge from main cohort

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.

PPI rates continue downward trend.

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.

Real-world data5
% Evolut patients with in-hospital 
permanent pacemaker implantation
(excluding baseline PPI/ICD)

These rates include TAV-in-SAV and TAV-in-TAV treated patients.  


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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.