Edwards SAPIEN XT™ THV

Edwards SAPIEN XT Transcatheter Heart Valve

Edwards’ Transcatheter Valve History

* Edwards SAPIEN XT is pending CE Mark;

2002 2006 2010

The advanced design of the Edwards SAPIEN XT transcatheter valve restores proper hemodynamics, maintains valve performance, and respects the anatomical structure of the heart.

Edwards SAPIEN XT Transcatheter Heart Valve

* Edwards SAPIEN XT is pending CE Mark;

Edwards SAPIEN XT™ Transcatheter Heart Valve

Technologically advanced leaflet design and manufacturing based on Edwards’ clinically

proven aortic tissue valves

Optimized frame height for proper placement and non-interference with the surrounding anatomy

High radial strength provides the circularity necessary for proper hemodynamics and valve

durability

* Edwards SAPIEN XT is pending CE Mark;

Edwards SAPIEN XT™ Valve UtilizesBovine Pericardial Tissue

• The Edwards SAPIEN™ transcatheter heart valve incorporates the same manufacturing processes used on premier Carpentier-Edwards PERIMOUNT Magna™ pericardial valves

• Bovine pericardial tissue is the standard of care in surgical heart valves

64%36%

1%

1. Bovine Pericardial

2. Native Porcine

3. Biological

Aortic ValvesSplit by Tissue Type

* Edwards SAPIEN XT is pending CE Mark;

Bovine Pericardial Tissue has clinically proven long term durability

Bovine pericardial tissue contains a uniquely dense, layered collagen structure*

Bovine pericardial has more than 20 years of proven clinical performance

200 mm200 mm

Bovine Pericardial Porcine Pericardial

Pericardial Tissue Yield Strength [Newtons]

*Source: Internal R&D Data

Bovine Pericardial is a strong and resistant tissue *

0

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30

35

Porcine (0.15 - 0.3 mm) Equine (0.3 - 0.4 mm) Bovine (0.3 - 0.4 mm)

0

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Porcine (0.15 - 0.3 mm) Equine (0.3 - 0.4 mm) Bovine (0.3 - 0.4 mm)BovinePorcine

Edwards SAPIEN XT™ Valve’s proprietary surgical leaflet shape is designed for even stress distribution, to support valve durability

• New leaflet design is similar to Carpentier-Edwards PERIMOUNT Magna™ valve leaflet

• Design of Edwards SAPIEN XT™ leaflet builds upon Edwards Lifesciences’ 50 years experience in heart valve technology

Edwards SAPIEN XT leafletEdwards surgical heart valve leaflet

* Edwards SAPIEN XT is pending CE Mark

• The individual valve leaflets on the Edwards SAPIEN XT THV are matched for thickness and elasticity

• Edwards proprietary leaflet matching process promotes consistent leaflet function and coaptation

Edwards SAPIEN XT Valve Incorporates Edwards’ Proprietary Leaflet Matching Technology

* Edwards SAPIEN XT is pending CE Mark;

• Calcification is the number one cause of SVD in implanted valves• There are two major Calcium binding sites that lead to calcification

1. Glutaraldehyde molecules / 2. Phospholipid molecules

2. Patented chemical treatment removes 98% of

phospholipids

1. Heat treatment removes unstable glutaraldehyde

molecules

Carpentier-Edwards ThermaFixTM process

81% less 75% less

State-of-the-art Carpentier Edwards ThermaFix™

process helps prevent calcification

ThermaFix™ is the only anti-calcification treatment that removes

both Ca+ binding sites

In vivo tests show an 75%+ reduction of Ca+ uptake in tissue vs. a process that would only

remove one binding site

10.96

3.862.53

0.64

28-day Rabbit, Intramuscular 20-week Sheep, Aortic implant

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Edwards SAPIEN XT™ frame height is optimized for proper placement and non-interference with the surrounding anatomy

• Fits within the annulus, minimizing the risk of Atrio Ventricular block and disruption with mitral leaflet function

• Lies below the coronary arteries allowing clear access for future Percutaneous Coronary Interventions

* Edwards SAPIEN XT is pending CE Mark;

Edwards SAPIEN XT™ has high radial strength providing the circularity necessary for proper hemodynamics and valve durability

* Edwards SAPIEN XT is pending CE Mark;

• Circularity and proper coaptation are related• Proper coaptation is a requisite for durability and proper hemodynamics• Balloon expandabledeployement ensures reaching the nominal diameter

• In-vivo testing comparison demonstrates the Edwards SAPIENTM THV has a larger EOA than stented or stentless valves, and generates less patient prosthesis mismatch

• The Edwards SAPIEN XTTM THV has similar EOA than the SAPIENTM THV

Larger EOA than leading Edwards surgical valve and Low PPM incidence

Edwards SAPIENTM THV

For annulus < 20 mm

Indexed EOA*

(cm2/m2)

0.87 0.74

*SOURCE: Clavel et al.; JACC Vol.53 ; No 20: 2009:1883-91

0.780.92

Edwards PERIMOUNTTM Magna

For annulus > 20 mm

NovaFlex™ Transfemoral Delivery System

• 18 French profile improves ease-of-access

• Innovative catheter tip enhances ability to smoothly cross the native valve

• Steerable catheter enables controlled navigation in challenging anatomies, including horizontal aortas

• Delivery balloon catheter engineered for predictably accurate valve placement

Edwards NovaFlex Delivery System

* Edwards NovaFlex is pending CE Mark;.

• Hydrophilic coating designed for easy insertion • Tri-seal valve technology designed for

hemostasis

Edwards NovaFlex’s 18F profile improves ease of access

37% Reduction in Cross-sectional area

Advanced introducer sheath

* Edwards NovaFlex is pending CE Mark;

Short distal segment fortight aortic arches

Edwards NovaFlex’s steerable catheter enables controlled navigation in challenging anatomies, including horizontal aortas

Steerable catheter facilitates navigation and

delivery81mm avg.

* Edwards NovaFlex is pending CE Mark; not available in the USA.

Edwards NovaFlex™ ’s innovative catheter tip enhances ability to smoothly cross the native valve

Delivery balloon catheter engineered for predictably accurate valve placement

* Edwards NovaFlex is pending CE Mark;

Edwards SAPIEN XT Transfemoral Kit

Edwards SAPIEN XTTM Valve

NovaFlexTM Delivery System

NovaFlex Balloon Catheter

Atrion QLInflation Device

NovaFlex Dilator Kit

NovaFlexTM Introducer Sheath

Edwards SAPIEN XTTM Crimper

* Edwards NovaFlex is pending CE Mark;

Ascendra 2™ Transapical Delivery System

Under clinical evaluation in Europe within the Prevail TA study

Edwards SAPIEN XT™ Transcatheter Heart Valve with the Ascendra 2™ Transapical Delivery System

Ascendra 2™ Delivery System

Combining enhanced procedural control and improved outcomes for the transapical approach, the Ascendra 2™ system delivers the most advanced transcatheter heart valve from the leader in heart valve therapy.

• Short access to native valve allows fast delivery with low contrast usage

• Reduced diameter for optimized access and closure

• New pusher/loader for single-handed operation

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Ascendra 2™ Transapical Delivery System optimizes procedure management

Ascendra 2 Transapical Delivery System

NEW FEATURES

22F sheath profile Optimizes apical access and closure Reduces sheath space in ventricle

Ascendra Ascendra 2

Introducer sheath comparison

22 Fr

26Fr

30% Reduction in Cross-sectional area

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Pusher:

Rotate to lock/unlock pusher, pin/pull mechanism

Pusher: Single-handed operation

Loader: Depress buttons for hemostatic control

Loader: Rotate pusher cap for hemostatic control

Ascendra 1 Ascendra 2

Ascendra 2™ transapical delivery system designed to optimize procedure management

New pusher and loader to ease single-handed operation

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24

Edwards SAPIEN XTTM THV

Ascendra 2TM Delivery System

Ascendra 2TM Balloon Aortic Valvuloplasty

Catheter Atrion QL

Inflation Device

Ascendra 2TM Introducer Sheath Set

Edwards THV complete kit:SAPIEN XTTM THV with Ascendra 2TM Delivery System

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