Evolut™ FX delivery catheter system for TAVR/TAVI

Transcatheter systems

Evolut™ FX system

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

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Indications, Safety, and WarningsThe 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 comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.

Features

Design goals

Precision. Control. Predictability.

View this animation showing the optimized stability layer of the Evolut™ FX TAV system.

Optimized stability layer for more predictable deployment

View this animation showing the redesigned tip and increased capsule flexibility of the Evolut™ FX TAV system.

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

View this animation showing the changes to the spine of the Evolut™ FX TAV system.

Single-spine shaft for greater flexibility and improved deliverability

View this animation showing the enhanced visualization of the Evolut™ FX TAV system.

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

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.^†

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.

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.

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