Edwards SAPIEN XT™ THV
Edwards SAPIEN XT Transcatheter Heart Valve
Edwards’ Transcatheter Valve History
* Edwards SAPIEN XT is pending CE Mark;
2002 2006 2010
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 Transcatheter Heart Valve
* 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 UtilizesBovine Pericardial Tissue
• The Edwards SAPIEN™ transcatheter heart valve incorporates the same manufacturing processes used on premier Carpentier-Edwards PERIMOUNT Magna™ pericardial valves
• Bovine pericardial tissue is the standard of care in surgical heart valves
64%36%
1%
1. Bovine Pericardial
2. Native Porcine
3. Biological
Aortic ValvesSplit by Tissue Type
* Edwards SAPIEN XT is pending CE Mark;
Bovine Pericardial Tissue has clinically proven long term durability
Bovine pericardial tissue contains a uniquely dense, layered collagen structure*
Bovine pericardial has more than 20 years of proven clinical performance
200 mm200 mm
Bovine Pericardial Porcine Pericardial
Pericardial Tissue Yield Strength [Newtons]
*Source: Internal R&D Data
Bovine Pericardial is a strong and resistant tissue *
0
5
10
15
20
25
30
35
Porcine (0.15 - 0.3 mm) Equine (0.3 - 0.4 mm) Bovine (0.3 - 0.4 mm)
0
5
10
15
20
25
30
35
Porcine (0.15 - 0.3 mm) Equine (0.3 - 0.4 mm) Bovine (0.3 - 0.4 mm)BovinePorcine
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 SAPIEN XT leafletEdwards surgical heart valve leaflet
* Edwards SAPIEN XT is pending CE Mark
• 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 Valve Incorporates Edwards’ Proprietary Leaflet Matching Technology
* Edwards SAPIEN XT is pending CE Mark;
• 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
2. Patented chemical treatment removes 98% of
phospholipids
1. Heat treatment removes unstable glutaraldehyde
molecules
Carpentier-Edwards ThermaFixTM process
81% less 75% less
State-of-the-art Carpentier Edwards ThermaFix™
process helps prevent calcification
ThermaFix™ is the only anti-calcification treatment that removes
both Ca+ binding sites
In vivo tests show an 75%+ reduction of Ca+ uptake in tissue vs. a process that would only
remove one binding site
10.96
3.862.53
0.64
28-day Rabbit, Intramuscular 20-week Sheep, Aortic implant
%C
a u
pta
ke
in t
issu
e
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
* Edwards SAPIEN XT is pending CE Mark;
• Circularity and proper coaptation are related• Proper coaptation is a requisite for durability and proper hemodynamics• Balloon expandabledeployement ensures reaching the nominal diameter
• 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
Larger EOA than leading Edwards surgical valve and Low PPM incidence
Edwards SAPIENTM THV
For annulus < 20 mm
Indexed EOA*
(cm2/m2)
0.87 0.74
*SOURCE: Clavel et al.; JACC Vol.53 ; No 20: 2009:1883-91
0.780.92
Edwards PERIMOUNTTM Magna
For annulus > 20 mm
NovaFlex™ Transfemoral 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 Delivery System
* Edwards NovaFlex is pending CE Mark;.
• Hydrophilic coating designed for easy insertion • Tri-seal valve technology designed for
hemostasis
Edwards NovaFlex’s 18F profile improves ease of access
37% Reduction in Cross-sectional area
Advanced introducer sheath
* Edwards NovaFlex is pending CE Mark;
Short distal segment fortight aortic arches
Edwards NovaFlex’s steerable catheter enables controlled navigation in challenging anatomies, including horizontal aortas
Steerable catheter facilitates navigation and
delivery81mm 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
Edwards SAPIEN XTTM Valve
NovaFlexTM Delivery System
NovaFlex Balloon Catheter
Atrion QLInflation Device
NovaFlex Dilator Kit
NovaFlexTM Introducer Sheath
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
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
Un
de
r cl
inic
al e
valu
atio
n in
Eu
rop
e w
ithin
th
e P
reva
il TA
stu
dy
Ascendra 2™ Transapical Delivery System optimizes procedure management
Ascendra 2 Transapical Delivery System
NEW FEATURES
22F sheath profile Optimizes apical access and closure Reduces sheath space in ventricle
Ascendra Ascendra 2
Introducer sheath comparison
22 Fr
26Fr
30% Reduction in Cross-sectional area
Un
de
r cl
inic
al e
valu
atio
n in
Eu
rop
e w
ithin
th
e P
reva
il TA
stu
dy
Pusher:
Rotate to lock/unlock pusher, pin/pull mechanism
Pusher: Single-handed operation
Loader: Depress buttons for hemostatic control
Loader: Rotate pusher cap for hemostatic control
Ascendra 1 Ascendra 2
Ascendra 2™ transapical delivery system designed to optimize procedure management
New pusher and loader to ease single-handed operation
Un
de
r cl
inic
al e
valu
atio
n in
Eu
rop
e w
ithin
th
e P
reva
il TA
stu
dy
24
Edwards SAPIEN XTTM THV
Ascendra 2TM Delivery System
Ascendra 2TM Balloon Aortic Valvuloplasty
Catheter Atrion QL
Inflation Device
Ascendra 2TM Introducer Sheath Set
Edwards THV complete kit:SAPIEN XTTM THV with Ascendra 2TM Delivery System
Un
de
r cl
inic
al e
valu
atio
n in
Eu
rop
e w
ithin
th
e P
reva
il TA
stu
dy