Evolut™ FX TAVR system

Setting new expectations

We made the new Evolut FX TAVR system easier to use so you can deliver with confidence and deploy with accuracy.

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Alert Indications, Safety, and Warnings
Evolut FX transcatheter aortic valve and delivery catheter

Design goals — Precision. Control. Predictability.

Optimized stability layer for more predictable deployment.
 

Redesigned tip and increased capsule flexibility for more dilator-like access and to better accommodate the most challenging anatomies.

 

Single-spine shaft for greater flexibility and improved deliverability.

 

Enhanced visualization. Radiopaque markers provide a reference for deployment depth and commissure location.

Performance as compared to Evolut™ PRO+ system in bench testing. Bench testing may not be indicative of clinical performance.

Performance in bench testing

Deployment stability

The Evolut FX stability layer increases catheter support during deployment and provides 50% less ventricular movement.*

Evolut FX conforms to the native anatomy more easily for a 36% improvement in deployment coaxiality.*

Deliverability

The Evolut FX system has a 33% reduction in insertion force (smoother) into simulated vasculature with a more flexible capsule.*

Evolut FX nosecone

Illustration of the Evolut FX nosecone flexible capsule

Evolut PRO+ nosecone

Illustration of the Evolut PRO+ nosecone flexible capsule

The Evolut FX system has a 38% reduction in tracking force in challenging anatomies.*

The Evolut FX system increases flexibility for 360° range of motion for greater control.*

Illustration showing the range of motion of the Evolut PRO+ TAV system
Illustration showing the range of motion of the Evolut FX TAV system

*Performance as compared to Evolut PRO+ system in bench testing. Bench testing may not be indicative of clinical performance.

Commissure alignment

Commissural alignment facilitates future coronary access.1

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.2

Procedural vision expanded

Using the valve features of the Evolut FX system, and following Evolut procedural technique, commissure alignment can be achieved.

95%

commissure alignment

In early first-in-human experience, commissure alignment was achieved 95% of the time with the Evolut FX system.3

Learn more about commissure alignment

Resources

Manuals and technical guides

Access instructions for use and other technical manuals in the Medtronic manual library. Search by the product name (e.g., Evolut) or model number. You may also call 800-961-9055 for a copy of a manual.

pdf Evolut FX system barcode and ordering information (.pdf)

701KB

Barcode and ordering
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pdf Evolut FX system product specifications (.pdf)

352KB

Product specifications
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References

1

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. February 2022;15(2):e011045.

2

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.

3

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.