Evolut™ FX System for transcatheter aortic valve implantation (TAVI)
The Evolut™ FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVI procedures.
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Overview
Predictable performance
The Evolut™ FX system enhancements make TAVI procedures easier to visualize and more predictable.
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.*
Deliverability
The Evolut™ FX system has a 33% reduction in insertion force (smoother) into simulated vasculature with a more flexible capsule.*
Evolut™ FX nosecone
Evolut™ PRO+ nosecone
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.*
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 |
Resources
Clinical evidence
Similar products
Confida™ Brecker guidewire
The Confida™ Brecker guidewire is specifically designed for transcatheter aortic valve replacement (TAVI) procedures.
Evolut™ FX+ system
The Evolut™ FX+ transcatheter aortic valve system is designed with specific features intended to enable lifetime management solutions such as coronary access.
Evolut™ PRO+ system
The Evolut™ PRO+ TAVI system features the lowest delivery profile for 23–29 mm valves and advanced sealing with an external tissue wrap on all valve sizes.
*
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.