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Transcatheter systems

Evolut™ FX system

<p>The Evolut™ FX transcatheter aortic valve implantation (TAVI) system sets expectations for precision, control, and predictability in TAVI procedures.</p>

Features

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.

50%

less ventricular
movement

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

This is an illustration of the Evolut™ FX nosecone flexible capsule.

Evolut™ PRO+ nosecone

This is an illustration of the Evolut™ PRO+ nosecone flexible capsule.


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

33%

reduction in
insertion force

38%

reduced
tracking force


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

This is an illustration showing the range of motion of the Evolut™ PRO+ transcatheter aortic valve system.
This is an illustration showing the range of motion of the Evolut™ FX transcatheter aortic valve system.


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


Ordering information

Bioprosthesis — Evolut™ FX valve

Item number Valve size (mm) Aortic annulus diameter (mm)
EVOLUTFX-23 23 17/18–20
EVOLUTFX-26 26 20–23
EVOLUTFX-29 29 23–26
EVOLUTFX-34 34 26–30


Loading system — Evolut™ FX loading system

Item number Description
L-EVOLUTFX-2329 Loading system for use with 23, 26, and 29 mm TAV
L-EVOLUTFX-34 Loading system for use with 34 mm TAV


Delivery catheter system — Evolut™ FX delivery catheter system with InLine™ sheath

Item number Description Delivery system size Delivery system working length (cm)
D-EVOLUTFX-2329 Delivery system for use with 23, 26, 29 mm TAV 14 Fr equivalent (6 mm capsule outer diameter) 108
D-EVOLUTFX-34 Delivery system for use with 34 mm TAV 18 Fr equivalent (7.33 mm capsule outer diameter) 108

 

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

‡ Measurement for TAV-in-SAV only.

This product is licenced with Health Canada as EVOLUT FX TRANSCATHETER AORTIC VALVE on Health Canada licence number MDL #: 107535.
EVOLUT FX DELIVERY CATHETER SYSTEM on Health Canada licence number MDL #: 97836.