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Edwards SAPIEN XT™ THV
Edwards SAPIEN XT
Transcatheter Heart Valve
Edwards’ Transcatheter Valve History


      2002        2006           2010




                                 * Edwards SAPIEN XT is pending CE Mark;
Edwards SAPIEN XT Transcatheter Heart Valve


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 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 Utilizes
Bovine Pericardial Tissue

• The Edwards SAPIEN™ transcatheter
  heart valve incorporates the same
  manufacturing processes used on
  premier Carpentier-Edwards
  PERIMOUNT Magna™ pericardial
  valves
                                                     Aortic Valves
                                                  Split by Tissue Type
• Bovine pericardial tissue is the           1%
                                                                  1. Bovine Pericardial
  standard of care in surgical heart
  valves                               36%

                                                   64%            2. Native Porcine


                                                                  3. Biological


                                                   * Edwards SAPIEN XT is pending CE Mark;
Bovine Pericardial Tissue
    has clinically proven long term durability
    Bovine pericardial tissue contains a uniquely                                                            Bovine Pericardial
         dense, layered collagen structure*                                                          is a strong and resistant tissue *
                                                                                          35                  35
                                                                                                 Mean +/- Pericardial Tissue Yield
                                                                                                          SEM       Mean +/- SEM                                          Strength [Newtons]
                                                                                          30                  30




                                                                                                                Tissue Yield Strength (N)
                                                              Tissue Yield Strength (N)
                                                                                          25                                                25

                                                                                          20                                                20

                                                                                          15                                                15

                                                                                          10                                                10
                             200 m                    200 m
                                                                                          5                                                 5

            Bovine Pericardial       Porcine Pericardial                                  0                                                 0
                                                                                               Porcine (0.15 - 0.3 mm)                              Porcine
                                                                                                                                                 Porcine (0.3 - 0.4 mm)
                                                                                                                                                 Equine (0.15 - 0.3 mm)     Bovine
                                                                                                                                                                          Bovine (0.3 --0.4 mm)
                                                                                                                                                                           Equine (0.3 0.4 mm)    Bovine (0.3 - 0.4 mm)
                                                                                                                                                 Pericardium Species      Pericardium Species
    Bovine pericardial has more than 20 years of proven clinical performance




*Source: Internal R&D Data
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 surgical                   Edwards SAPIEN XT leaflet
            heart valve leaflet




                                                           * Edwards SAPIEN XT is pending CE Mark
Edwards SAPIEN XT Valve Incorporates Edwards’
Proprietary Leaflet Matching Technology




• 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 is pending CE Mark;
State-of-the-art Carpentier Edwards ThermaFix™
    process helps prevent calcification
•       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


         ThermaFix™ is the only anti-                                                    In vivo tests show an 75%+ reduction of Ca+
     calcification treatment that removes                                               uptake in tissue vs. a process that would only
             both Ca+ binding sites                                                                 remove one binding site


             Carpentier-Edwards ThermaFixTM process                                    28-day Rabbit, Intramuscular   20-week Sheep, Aortic implant


                                                                                         10.96




                                                                %Ca uptake in tissue
                                                                                                      81% less                         75% less

                                                                                                       3.86
    1. Heat treatment removes          2. Patented chemical                                                                2.53
      unstable glutaraldehyde        treatment removes 98% of
                                                                                                                                        0.64
              molecules                    phospholipids
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


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




                                                    * Edwards SAPIEN XT is pending CE Mark;
Larger EOA than leading Edwards surgical valve
 and Low PPM incidence
• 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

    Indexed EOA*
           (cm2/m2)                                     Edwards           Edwards
                                                      SAPIENTM THV   PERIMOUNTTM Magna




                            For annulus
                              < 20 mm
                                                             0.87          0.74

                            For annulus
                              > 20 mm
                                                             0.92          0.78



 *SOURCE: Clavel et al.; JACC Vol.53 ; No 20: 2009:1883-91
NovaFlex™ Transfemoral
Delivery System
Edwards NovaFlex 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 is pending CE Mark;.
Edwards NovaFlex’s 18F profile
improves ease of access

    37% Reduction in            Advanced introducer sheath
   Cross-sectional area




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




                                                   * Edwards NovaFlex is pending CE Mark;
Edwards NovaFlex’s steerable catheter enables controlled navigation in
challenging anatomies, including horizontal aortas
            Steerable catheter                Short distal segment for
         facilitates navigation and             tight aortic arches
                   delivery                             81mm
                                                         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




                                             NovaFlexTM Delivery System

Edwards SAPIEN XTTM Valve
                                                                                          NovaFlex Balloon Catheter




                        NovaFlexTM Introducer Sheath




                                                                                                      Atrion QL
                                                                                                  Inflation Device
                                                               NovaFlex Dilator Kit
    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




                                                                          Under clinical evaluation in Europe within the Prevail TA study
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
Ascendra 2™ Transapical Delivery System
optimizes procedure management
                            Ascendra 2
                     Transapical Delivery System




                                                                              Under clinical evaluation in Europe within the Prevail TA study
                                                        30% Reduction
                                                    in Cross-sectional area

NEW FEATURES
22F sheath profile
    Optimizes apical access and closure            22               26
                                                    Fr               Fr
    Reduces sheath space in ventricle

                                                    Introducer sheath
                                                        comparison
                                                   Ascendra Ascendra 2
Ascendra 2™ transapical delivery system designed
to optimize procedure management

New pusher and loader to ease single-handed operation




                                                                                                     Under clinical evaluation in Europe within the Prevail TA study
                Ascendra 1                                       Ascendra 2




 Pusher:
 Rotate to lock/unlock pusher, pin/pull mechanism

                                                         Pusher: Single-handed operation




Loader: Rotate pusher cap for hemostatic control

                                                    Loader: Depress buttons for hemostatic control
Edwards THV complete kit:
SAPIEN XTTM THV with Ascendra 2TM Delivery System




                                                                                           Under clinical evaluation in Europe within the Prevail TA study
                                          Ascendra 2TM Delivery System




                                               Ascendra 2TM Introducer Sheath Set
    Edwards SAPIEN XTTM THV




                              Ascendra 2TM Balloon
                               Aortic Valvuloplasty                      Atrion QL
                                     Catheter                        Inflation Device 24

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Edwards sapien xt final, nova flex and ascendra 2

  • 3. Edwards’ Transcatheter Valve History 2002 2006 2010 * Edwards SAPIEN XT is pending CE Mark;
  • 4. Edwards SAPIEN XT Transcatheter Heart Valve 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 is pending CE Mark;
  • 5. 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;
  • 6. Edwards SAPIEN XT™ Valve Utilizes Bovine Pericardial Tissue • The Edwards SAPIEN™ transcatheter heart valve incorporates the same manufacturing processes used on premier Carpentier-Edwards PERIMOUNT Magna™ pericardial valves Aortic Valves Split by Tissue Type • Bovine pericardial tissue is the 1% 1. Bovine Pericardial standard of care in surgical heart valves 36% 64% 2. Native Porcine 3. Biological * Edwards SAPIEN XT is pending CE Mark;
  • 7. Bovine Pericardial Tissue has clinically proven long term durability Bovine pericardial tissue contains a uniquely Bovine Pericardial dense, layered collagen structure* is a strong and resistant tissue * 35 35 Mean +/- Pericardial Tissue Yield SEM Mean +/- SEM Strength [Newtons] 30 30 Tissue Yield Strength (N) Tissue Yield Strength (N) 25 25 20 20 15 15 10 10 200 m 200 m 5 5 Bovine Pericardial Porcine Pericardial 0 0 Porcine (0.15 - 0.3 mm) Porcine Porcine (0.3 - 0.4 mm) Equine (0.15 - 0.3 mm) Bovine Bovine (0.3 --0.4 mm) Equine (0.3 0.4 mm) Bovine (0.3 - 0.4 mm) Pericardium Species Pericardium Species Bovine pericardial has more than 20 years of proven clinical performance *Source: Internal R&D Data
  • 8. 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 surgical Edwards SAPIEN XT leaflet heart valve leaflet * Edwards SAPIEN XT is pending CE Mark
  • 9. Edwards SAPIEN XT Valve Incorporates Edwards’ Proprietary Leaflet Matching Technology • 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 is pending CE Mark;
  • 10. State-of-the-art Carpentier Edwards ThermaFix™ process helps prevent calcification • 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 ThermaFix™ is the only anti- In vivo tests show an 75%+ reduction of Ca+ calcification treatment that removes uptake in tissue vs. a process that would only both Ca+ binding sites remove one binding site Carpentier-Edwards ThermaFixTM process 28-day Rabbit, Intramuscular 20-week Sheep, Aortic implant 10.96 %Ca uptake in tissue 81% less 75% less 3.86 1. Heat treatment removes 2. Patented chemical 2.53 unstable glutaraldehyde treatment removes 98% of 0.64 molecules phospholipids
  • 11. 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;
  • 12. Edwards SAPIEN XT™ has high radial strength providing the circularity necessary for proper hemodynamics and valve durability • Circularity and proper coaptation are related • Proper coaptation is a requisite for durability and proper hemodynamics • Balloon expandabledeployement ensures reaching the nominal diameter * Edwards SAPIEN XT is pending CE Mark;
  • 13. Larger EOA than leading Edwards surgical valve and Low PPM incidence • 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 Indexed EOA* (cm2/m2) Edwards Edwards SAPIENTM THV PERIMOUNTTM Magna For annulus < 20 mm 0.87 0.74 For annulus > 20 mm 0.92 0.78 *SOURCE: Clavel et al.; JACC Vol.53 ; No 20: 2009:1883-91
  • 15. Edwards NovaFlex 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 is pending CE Mark;.
  • 16. Edwards NovaFlex’s 18F profile improves ease of access 37% Reduction in Advanced introducer sheath Cross-sectional area • Hydrophilic coating designed for easy insertion • Tri-seal valve technology designed for hemostasis * Edwards NovaFlex is pending CE Mark;
  • 17. Edwards NovaFlex’s steerable catheter enables controlled navigation in challenging anatomies, including horizontal aortas Steerable catheter Short distal segment for facilitates navigation and tight aortic arches delivery 81mm avg. * Edwards NovaFlex is pending CE Mark; not available in the USA.
  • 18. 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;
  • 19. Edwards SAPIEN XT Transfemoral Kit NovaFlexTM Delivery System Edwards SAPIEN XTTM Valve NovaFlex Balloon Catheter NovaFlexTM Introducer Sheath Atrion QL Inflation Device NovaFlex Dilator Kit Edwards SAPIEN XTTM Crimper * Edwards NovaFlex is pending CE Mark;
  • 20. Ascendra 2™ Transapical Delivery System Under clinical evaluation in Europe within the Prevail TA study
  • 21. Edwards SAPIEN XT™ Transcatheter Heart Valve with the Ascendra 2™ Transapical Delivery System Ascendra 2™ Delivery System Under clinical evaluation in Europe within the Prevail TA study 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
  • 22. Ascendra 2™ Transapical Delivery System optimizes procedure management Ascendra 2 Transapical Delivery System Under clinical evaluation in Europe within the Prevail TA study 30% Reduction in Cross-sectional area NEW FEATURES 22F sheath profile  Optimizes apical access and closure 22 26 Fr Fr  Reduces sheath space in ventricle Introducer sheath comparison Ascendra Ascendra 2
  • 23. Ascendra 2™ transapical delivery system designed to optimize procedure management New pusher and loader to ease single-handed operation Under clinical evaluation in Europe within the Prevail TA study Ascendra 1 Ascendra 2 Pusher: Rotate to lock/unlock pusher, pin/pull mechanism Pusher: Single-handed operation Loader: Rotate pusher cap for hemostatic control Loader: Depress buttons for hemostatic control
  • 24. Edwards THV complete kit: SAPIEN XTTM THV with Ascendra 2TM Delivery System Under clinical evaluation in Europe within the Prevail TA study Ascendra 2TM Delivery System Ascendra 2TM Introducer Sheath Set Edwards SAPIEN XTTM THV Ascendra 2TM Balloon Aortic Valvuloplasty Atrion QL Catheter Inflation Device 24