31 Oct 2017

Edwards Lifesciences: SAPIEN XT™ Valve and SAPIEN 3™ Valve

Transcatheter aortic valve devices

The Edwards SAPIEN XT™ Valve and SAPIEN 3™ Valves are built upon the proven benefits of the SAPIEN valve family. Designed to minimize paravalvular leak while achieving an ultra-low delivery profile.

Edwards, Edwards Lifesciences, Edwards SAPIEN, Edwards SAPIEN XT, Edwards SAPIEN 3, SAPIEN, SAPIEN XT and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation.

Images courtesy of Edwards Lifesciences LLC, Irvine, CA

Table of content

Edwards SAPIEN XT™ Valve
Edwards SAPIEN 3™ Valve

SAPIEN XT™ Valve introduction

The Edwards SAPIEN XT transcatheter heart valve is approved for delivery with the NovaFlex+ system and Ascendra+ system in 23 mm, 26 mm and 29 mm valve sizes.

Balloon-expandable valve design for predictable deployment
Low profile 16F access^*

^*For the 23 mm Edwards SAPIEN XT valve via the transfemoral procedure.

Approved for valve-in-valve procedures

In failed surgical aortic bioprostheses for patients at high or greater surgical risk

1 - CIRCULARITY
- Promotes uniform leaflet coaptation for valve durability and optimal haemodynamic performance
- Circular valve design with high radial strength promotes uniform leaflet coaptation
- Predictable circular valve deployment through balloon-expandable inflation

2 - PROVEN VALVE TISSUE
- Edwards bovine pericardial tissue valves are the gold standard in surgical valve replacement
- Leaflet design and matching enhance stress distribution
- The Carpentier-Edwards ThermaFix process minimises the risk of calcification

3 - FRAME HEIGHT
- Designed to respect the cardiac anatomy and minimise the risk of conduction system interference

Edwards SAPIEN XT	Native annulus diameter*
20 mm	16-19 mm
23 mm	18-22 mm
26 mm	21-25 mm
29 mm	24-27 mm

*as assessed by TEE

Edwards SAPIEN XT™ Valve animation

Edwards SAPIEN XT™ Transcatheter Heart Valve with the Nofaflex+ Transfemoral system

Movie 18. NovaFlex+ TF procedural animation

Edwards SAPIEN XT™ Transcatheter Heart Valve with the Ascendra+ Delivery system (Transaortic)

Movie 19. Ascendra+ TAo procedural animation

Edwards SAPIEN XT™ Transcatheter Heart Valve with the Ascendra+ Delivery system (Transapical)

Movie 20. Ascendra+ TA procedural animation

General characteristics:

Design	Balloon-expandable
Frame	Cobalt chromium
Leaflets	Bovine pericardial tissue leaflets
Valve size (mm)	20 mm, 23 mm, 26 mm, 29 mm
Delivery system diameter	- Transfemoral (Figure 80): 16 Fr (for valve size 20 mm, 23 mm), 18 Fr (for valve size 26 mm), 20 Fr (for valve size 29 mm) - Transapical and Transaortic (Figure 81): 24 Fr (for valve size 23 mm, 26 mm), 26 Fr (for valve size 29 mm)
Implantation access	Transfemoral, Transapical, Transaortic
Repositionable	No
Retrievable after being fully deployed	No
Additional cuff to reduce AR	No
Anchoring mechanism	-
Tactile feedback during deployment	-
Large stent cell design	Yes
Markers to facilitate deployment	Radiopaque frame
Motorised delivery system	-
Anticalcification technology	Yes

CE mark status: Yes - 02/03/2010

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SAPIEN 3™ Valve introduction

The Edwards SAPIEN 3™ Valve is built upon the proven benefits of the SAPIEN valve family. Designed to minimize paravalvular leak while achieving an ultra-low delivery profile, while maintaining radial strength for circularity. The expanded annulus size coverage and reduced minimum access vessel diameters.

1 - FRAME DESIGN
Enhanced frame geometry for ultra-low delivery profile High radial strength for circularity and optimal haemodynamics

2 - BOVINE PERICARDIAL TISSUE
Optimised leaflet shape Carpentier-Edwards ThermaFix process for anticalcification

3 - OUTER SKIRT
Designed to reduce paravalvular leak

4 - LOW FRAME HEIGHT
Respects the cardiac anatomy

Edwards SAPIEN 3	Native annulus diameter*
20 mm	16-19 mm
23 mm	18-22 mm
26 mm	21-25 mm
29 mm	24-28 mm

Edwards SAPIEN 3	Native annulus area	Area-derived diameter
20 mm	273-345 mm²	10.6-21.0 mm
23 mm	338-430 mm²	20.7-23.4 mm
26 mm	430-546 mm²	23.4-26.4 mm
29 mm	540-680 mm²	26.2-29.5 mm

General characteristics:

Design	Balloon-expandable (Figure 75)
Frame	Cobalt chromium
Leaflets	Bovine pericardial tissue leaflets
Valve size (mm)	20*mm, 23 mm, 26 mm, 29 mm
Delivery system diameter	- Transfemoral (Figure 74): 14 Fr (for valve size 20 mm, 23 mm, 26 mm), 16 Fr (for valve size 29 mm) - Transapical and Transaortic (Figure 76): 18 Fr (for valve size 20 mm, 23 mm, 26 mm), 21 Fr (for valve size 29 mm
Implantation access	Transfemoral, Transapical, Transaortic
Repositionable	No
Retrievable after being fully deployed	No
Additional cuff to reduce AR	Yes - outer skirt
Anchoring mechanism	-
Tactile feedback during deployment	-
Large stent cell design	Yes
Markers to facilitate deployment	Yes
Motorised delivery system	No
Anticalcification technology	Yes

CE mark status: Yes - 27/01/2014

Special features:

*20mm SAPIEN 3 valve is currently under clinical investigation and not available for commercial use

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