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Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
Edwards sapien xt final, nova flex and ascendra 2
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Edwards sapien xt final, nova flex and ascendra 2

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  • 1. Edwards SAPIEN XT™ THV
  • 2. Edwards SAPIEN XTTranscatheter Heart Valve
  • 3. Edwards’ Transcatheter Valve History 2002 2006 2010 * Edwards SAPIEN XT is pending CE Mark;
  • 4. Edwards SAPIEN XT Transcatheter Heart ValveThe advanced design of the Edwards SAPIEN XTtranscatheter valve restores proper hemodynamics,maintains valve performance, and respects theanatomical 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 valvesOptimized 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 UtilizesBovine 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 shapeis 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 yearsexperience 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 properplacement 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 thecircularity 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
  • 14. NovaFlex™ TransfemoralDelivery System
  • 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 profileimproves 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 inchallenging 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 tipenhances 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 SystemEdwards 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 Valvewith the Ascendra 2™ Transapical Delivery System Ascendra 2™ Delivery System Under clinical evaluation in Europe within the Prevail TA studyCombining enhanced procedural control and improved outcomes for thetransapical approach, the Ascendra 2™ system delivers the most advancedtranscatheter 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 Systemoptimizes procedure management Ascendra 2 Transapical Delivery System Under clinical evaluation in Europe within the Prevail TA study 30% Reduction in Cross-sectional areaNEW FEATURES22F 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 designedto optimize procedure managementNew 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 operationLoader: 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

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