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;
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
