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Evolut TAVI Implant Procedure

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Transcatheter aortic valve implantation (TAVI)

Evolut™ TAVI implant procedure

with the cusp overlap technique

Delivering on ease of use through a more predictable and streamlined procedural experience.

Alert Indications, Safety, and Warnings
Evolut FX transcatheter aortic valve being deployed using the Evolut TAVR/TAVI implant procedure

Precision

Facilitate implant depth accuracy
The cusp overlap view isolates the noncoronary cusp and elongates the left ventricular outflow tract, providing a greater visual separation between the basal annular plane and the conduction system, and an accurate, patient-specific anatomical view to assess and achieve target implant depth.1

Control

Predictable valve deployment
Slow deployment starting from a supra-annular position allows the valve to descend to its target position, providing users with control over valve deployment and requiring minimal catheter manipulation, which minimizes the risk of interaction with the conduction system.

Optimize PRO second interim analysis1

The cusp overlap technique with an optimized care pathway continues to show dependable clinical outcomes.*

Accuracy when it matters most

  • Reproducible single-digit pacemaker rate: 9.8% PPI rate at 30 days
  • No ≥ moderate PVL at discharge
  • 1 day median discharge
  • No PPM in 91% of patients at discharge

Devices used: 91.5% Evolut™ PRO+/8.0% Evolut™ PRO.
* This is an interim analysis of 400 main cohort patients. At the conclusion of the study, more than 650 patients will have been evaluated.

Real-world accuracy

Accurate depth assessment at the NCC, facilitated with the cusp overlap technique, has resulted in single-digit pacemaker rates in several single-center and multicenter clinical studies.

Single-digit new 30-day permanent pacemaker implantation rates

Bar chart highlighting 30-day pacemaker implant rates for multiple studies following TAVR or TAVI, depending on region or country

Excludes patients with baseline implantable cardioverter defibrillator or pacemaker.
†Discharge rates.

Watch the Cusp Overlap technique.

Watch the technique

Related pages

Explore our other procedural guidance and outcomes you can expect from the Evolut platform.
Evolut transcatheter aortic valve with catheter accessing the coronary

Post-TAVI coronary access

Review the guidance
Evolut 29 mm transcatheter aortic valve within a circular outline

Durability starts with design

Explore our design
Top-down view of the Evolut transcatheter aortic valve within a circular outline

Comprehensive clinical evidence

Explore the data

References

1

Grubb JK, Gada H, Mittal S, et al. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights from the Optimize PRO Study. JACC Cardiovasc Interv. March 13, 2023;16(5):558–570.

2

Gada H. TAVR in Low Risk Patients. Presented at TVT 2019.

3

Gada H, et al. Reduction of Rates of Permanent Pacemaker Implantation With 34-MM Evolut™ R Using Cusp Overlap Technique. Presented at TCT Connect 2020.

4

Gada H, et al. Reproducibility of Cusp Overlap Technique to Reduce Permanent Pacemaker Implantation With Evolut™: The Latin American Experience. Presented at TCT Connect 2020.

5

Pisaniello AD, Makki HBE, Jahangeer S, Daniels MJ, Hasan R, Fraser DGW. Low Rates of Permanent Pacing Are Observed Following Self-Expanding Transcatheter Aortic Valve Replacement Using an Annular Plane Projection for Deployment. Circ Cardiovascular Interv. January 2021;14(1):e009258.

6

Mendiz OA, Noč M, Fava CM, et al. Impact of Cusp-Overlap View for TAVR with Self-Expandable Valves on 30 Day Conduction Disturbances. J Interv Cardiol. April 28, 2021;2021:9991528.

DISCLAIMER

The material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).

Please note that the intended use of a product may vary depending on geographical approvals. See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.

For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.

If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.

Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser. Medtronic products placed on European markets bear the CE mark.

For any further information, contact your local Medtronic representative.

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