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.

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 coaxial deployment.*

Deliverability

The Evolut FX system has a 33% improvement in insertion (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

Alignment of the THV commissure to the native valve commissure

Illustration showing the commissure alignment of an Evolut TAV system

Native valve

Illustration showing the commissure misalignment of an Evolut TAV system

Commissure alignment

Procedural vision expanded

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

TAV marker alignment in cusp overlap view

Evolut valve with illustration of markers for visual reference for TAV commissure location and alignment during deployment

Radiopaque markers are a visual reference for TAV commissure location and alignment during deployment.

Illustration of existing cusp overlap implant views of TAV with arrows to show marker alignment

Existing cusp overlap implant views provide standard anatomical reference point to identify native commissure.

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.

Stay connected

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Get support

Reach out to LifeLine CardioVascular Tech Support with questions: 877-526-7890

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.