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

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

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

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

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

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

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

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

Edwards SAPIEN Patients Show a Significant Improvement in Quality of Life 9

Edwards SAPIEN Patients Show a Significant Improvement in Functionality 10 10

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

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

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

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.

The Environment

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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