1. Design & Product Development Larry L Wood
Corporate Vice President & THV General Manager

2. Disclosure Statement of Financial Interest
I, Larry L Wood, do have a financial interest/ arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. 2 2

3. What Clinical Problem Were We Trying to Solve?
Patients aged > 70 yrs (median 78)
(Bouma. Heart 1999;82:143-8) 3

4. 1st Successful Transcatheter Aortic Valve
What Drove Us?
The patients treated were desperately ill and had no alternative; many were at imminent risk of death
1st Successful Transcatheter Aortic Valve
April 16, 2002 4

5. Edwards SAPIEN Clinician Inputs
Cribier-Edwards THV
Edwards SAPIEN THV
Clinical Learnings
23 mm Valve
Untreated Equine Tissue
Additional valve sizes needed to treat more patients.
Surgical community would require valve to leverage surgical learnings/durability.
23 and 26 mm Valves
Bovine Pericardial Tissue
Carpentier-Edwards ThermaFix Process**
Leaflet Matching Technology
Antegrade Approach
Approach too difficult in frail patients
Retrograde Approach
Retrograde Prototype
Delivery System
Commercial Delivery System
Crossability improvements required – valves were massively calcified and EOAs shockingly low.
** *No clinical data are available which evaluate the long-term
impact of the Edwards Lifesciences tissue treatment in patients. 5

6. Current State of the Art
Procedural Key Learnings To Date Have Lead to Improved Clinical Results
State of the Art 2002
Current State of the Art
‘Right’ Sizing
23 mm valves used in 23mm annuluses
BAV
Required to be able to cross the native valve with the implant
Verified annulus sizing
Inflation
Quick inflation & deflation
‘Expansion’ Sizing
2 - 3mm larger than annulus for optimal sizing
BAV
Used to create flow during implantation
Provides warning for potential for coronary occlusion
Inflation
Hold for a few seconds to optimize THV EOA

7. Key Learnings – Valve Design The Challenge Is In Trade-off Choices
What We Liked
What We Wanted To Improve
Clinical Results
Balloon expandable positioning/Delivery simplicity
High redial strength
Discrete valve design
Proven tissue platform
Valve versatility
Articulating delivery system
Delivery system profile
Precision of placement
Retrieve
Reposition
Valve crossing
Accessories
Transapical delivery system ease of use

8. Edwards SAPIEN Clinical Results
Average TF EuroSCORE 29.3% (+/- 14.4%) (range 6.1 – 83) 8

9. Edwards SAPIEN Patients Show a Significant Improvement in Quality of Life9

10. Edwards SAPIEN Patients Show a Significant Improvement in Functionality10 10

11. 2009 THV Global Impact 4,000+ patients treated worldwide in 2009.
Procedural Success Rate continues to improve (>95%) 11

12. Edwards Development Priorities
What We Prioritized
What We Traded Off
Durability
Maintain radial strength
Maintain proven valve tissue
Simple to use
Improve placement precision
No rotational orientation required
Profile
Needed to be percutaneous
Single valve platform for multiple patient groups
TA/TF/Pulmonic
Repositionability
Simplicity suffered with increased delivery system complexity
Removable
Could not achieve radial strength goals with our self-expanding prototypes
Absolute Profile
Unwilling to compromise valve durability by changing tissue/radically changing design

13. Edwards SAPIEN XT Clinician Inputs
Edwards SAPIEN THV
Edwards SAPIEN XT THV
Clinical Learnings
23 and 26 mm Valves
Bovine Pericardial Tissue
Carpentier-Edwards ThermaFix Process**
Leaflet Matching Technology
Additional valve sizes needed to treat more patients.
True surgical valve construction preferred with indication expansion.
20, 23, 26 & 29 mm Valves
New Frame Design
Lower Crimp Profile Geometry
Cobalt-chromium Material
New Valve and Leaflet Design
Surgical Leaflet Design
** *No clinical data are available which evaluate the long-term
impact of the Edwards Lifesciences tissue treatment in patients.
* Edwards SAPIEN XT is pending CE Mark; not available in the USA. 13

14. Unique NovaFlex Design Solution
Stainless Steel Frame
Tissue Leaflets
Guidewire Lumen
Balloon Material
22F
Cobalt-Chromium Frame
Tissue Leaflets
Guidewire Lumen
18F
Edwards SAPIEN XT valve is
crimped proximal to the balloon to begin the procedure
Edwards SAPIEN XT valve is
then docked onto the balloon in the aorta
* Edwards SAPIEN XT & the NpvaFlex delivery system are pending CE Mark; not available in the USA.

15. The Environment

16. What to Watch For (TAVI)
Transcatheter heart valves will continue be a rapidly evolving field, with multiple approaches explored.
This is expensive and complex -- Edwards investment this year in THV will exceed $100M in an unstudied patient population and a changing clinical and regulatory environment.
With 95+% commercial procedural success rates, new entrants/designs will be challenged to produce equivalent patient results.
Edwards Lifesciences is passionately committed to leadership in transcatheter heart valves -- and to driving this new therapeutic option to high risk patients worldwide.

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