edwards sapien xt final, nova flex and ascendra 2
DESCRIPTION
TRANSCRIPT
![Page 1: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/1.jpg)
Edwards SAPIEN XT™ THV
![Page 2: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/2.jpg)
Edwards SAPIEN XT Transcatheter Heart Valve
![Page 3: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/3.jpg)
Edwards’ Transcatheter Valve History
* Edwards SAPIEN XT is pending CE Mark;
2002 2006 2010
![Page 4: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/4.jpg)
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;
![Page 5: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/5.jpg)
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;
![Page 6: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/6.jpg)
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;
![Page 7: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/7.jpg)
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
![Page 8: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/8.jpg)
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
![Page 9: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/9.jpg)
• 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;
![Page 10: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/10.jpg)
• 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
![Page 11: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/11.jpg)
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;
![Page 12: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/12.jpg)
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
![Page 13: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/13.jpg)
• 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
![Page 14: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/14.jpg)
NovaFlex™ Transfemoral Delivery System
![Page 15: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/15.jpg)
• 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;.
![Page 16: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/16.jpg)
• 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;
![Page 17: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/17.jpg)
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.
![Page 18: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/18.jpg)
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;
![Page 19: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/19.jpg)
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;
![Page 20: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/20.jpg)
Ascendra 2™ Transapical Delivery System
Under clinical evaluation in Europe within the Prevail TA study
![Page 21: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/21.jpg)
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
![Page 22: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/22.jpg)
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
![Page 23: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/23.jpg)
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
![Page 24: Edwards sapien xt final, nova flex and ascendra 2](https://reader033.vdocuments.us/reader033/viewer/2022061203/547cdbceb4af9fcf098b45c4/html5/thumbnails/24.jpg)
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