1. Medtronic CoreValve® | CoreValve® Evolut™ Transcatheter Aortic Valves

2. Clinical Challenges in TAVI
Clinical Need
Design Challenge
Access, even in patients with small or challenging vasculature
Low delivery profile
Alternative—non-femoral—access
Positioning, even in angulated or otherwise challenging anatomies
Step-wise deployment with ability adjust and refine valve position
Conformability to a wide range of patient anatomies—annulus size, shape, calcification
Full range of valve sizes
Conformability at the annulus with circularity at level of valve function
Durability long-term with hemodynamic and structural integrity
Optimal tissue selection for strength, pliability and thinness
Frame designed to reduce leaflet stress 1 2 3 4

3. System Components Valve Loading System Delivery System
Self-expanding Nitinol frame with porcine pericardial valve
Disposable cones and tubes used to compress the valve
True 18Fr catheter delivery system with AccuTrak® stability layer

4. CoreValve and CoreValve Evolut Valves
31mm
29mm
26mm
23mm
CoreValve
CoreValve Evolut

5. Anatomical Fit
Deliverability
Performance & Durability

6. CoreValve Design Legacy
Outflow
Supports valve commissures and enables controlled deployment
Low Radial Force
Waist
Promotes circularity, supports supra-annular valve
High Hoop Strength
Inflow
Conforms and seals to the annulus
High Radial Force 6 6 6

7. Supra-Annular Valve Design
Flexible frame conforms to native annulus shape while maintaining the bioprosthesis in a higher position
This decoupling of the valve from native annulus shape minimizes the impact of ellipticity at the valve level post deployment1
Patient 1
Patient 2
Patient 3
Data on file at Medtronic
Images courtesy of Drs. de Jaegere and Schultz, Erasmus MC, Rotterdam, The Netherlands

8. CoreValve Evolut Adds TruFit Technology
Customizes anatomical fit via a tailored height and shape
Optimizes coaptation in non-circular anatomy with supra-annular valve position
Leverages CoreValve Design Legacy
Outflow: Supports valve commissures and enables controlled deployment
Waist: Promotes circularity, supports supra-annular valve
Inflow: Conforms and seals to the annulus
TruFit technology = true anatomical fit
Conforms to the anatomy and promotes sealing with optimized interference and radial force

9. CoreValve Evolut Tailored Height and Shape
Reduced height
Reduce height of outflow for better fit, especially in angulated anatomies
45 mm
12 mm
Preserved coronary access
Maintains CoreValve cell geometry for coronary access
Preserved skirt length
Provides seal against paravalvular leak

10. CoreValve Evolut Optimized Interference and Radial Force
Optimized Performance
More consistent interference and radial force across annular size range while maintaining conformability

11. Full Range of Valve Sizes

12. Use in failed surgical bioprostheses Now CE Approved
Low post-procedural gradients 1
Large potential orifice area
Leaflets sit above the annulus where the frame is least constrained, opening up the valve for greater flow
Valve Inflow
Leaflets
Surgical Valve
CoreValve
Aortic Annulus
1. Dvir et al., TCT. Miami, Fl. Oct 2012

13. Anatomical Fit
Deliverability
Performance & Durability

14. AccuTrak® Delivery System
AccuTrak® Stability Layer
7cm
15Fr Fr Fr
Over-the-wire compatible
6 mm
Low-Profile Access
with true 18Fr profile across all valve sizes
Stable Deployment
with AccuTrak Stability Layer
Slow, Controlled Release
with partial repositionability

15. Clinical Experience with AccuTrak
Implants at a depth of mm minimize paravalvular leak
Example: 134 CoreValve patients treated at 2 experienced centers1
All implants performed using the AccuTrak delivery system
N=134
Patients (%)
Procedural Success
133 (99.2)
BAV
129 (98.5)
Balloon-Annulus Ratio
0.95  0.09
Depth of Implant
4.9  2
PVL > 2/4
0 (0)
Central leak
New LBBB
18 (13.4)
New Transient or Sustained AVB
17 (12.7)
New Pacemaker Implantation
12* (10.6)
Tchetche, et al., EuroIntervention 2012; e-publication
*12 of 113 patients without baseline pacemaker.

16. Approved Access Routes
Direct Aortic
Subclavian
Transfemoral

17. Anatomical Fit
Deliverability
Performance & Durability

18. Characteristics of Performance
Valve Design
Leaflet Geometry
Supra-annular
Tissue Selection Thickness Tensile Strength Pliability
Tissue Treatment Anti-calcification
Performance
Clinical Outcomes
Bench Testing

19. Frame Material Selection—Nitinol
Superelasticity
Shape Retention
Proven
Performance
Compact designs and small delivery systems
Self-anchoring
Controlled retraction for precise delivery and placement
Maintain valve shape
Resistant to corrosion
Low thrombogenicity
Conformable to patient anatomy
Fatigue performance 19

20. Porcine pericardium is the optimal tissue for valve performance and low-profile delivery
Porcine pericardium thickness is about half that of bovine. Thinner tissue prevents tissue damage during crimping, tracking, and deployment, allowing for low-profile delivery across all valve sizes.1,2 The ultimate tensile strength (UTS) and suture pull out stresses for porcine and bovine pericardium are not statistically different1,3 and peak physiologic stresses are significantly less than both UTS values4
Thin
Porcine Pericardium
Bovine Pericardium
Strong
Sacks MS. Uniaxial mechanical and structural properties of bovine versus porcine pericardial tissue. Medtronic Engineered Tissue Mechanics Laboratory. University of Pittsburgh, Pittsburgh, PA. January 17, Data on File.
Braga-Vilela AS, Pimentel ER, Marangoni S, Toyama MH, de Campos Vidal B. Extracellular matrix of porcine pericardium: Biochemistry and collagen architecture. J Membr Biol Jan;221(1):15-25.
Garcia Paez JM, Carrera A, Herrero EJ, et al. Influence of the selection of the suture material on the mechanical behavior of a biomaterial to be employed in the construction of implants. Part 2: porcine pericardium. J Biomater Appl. 2001;16:68-90.
Li, K and Sun, W. “Simulated thin pericardial bioprosthetic valve leaflet deformation under static pressure-only loading conditions: Implications for percutaneous valves” Ann Biomed Eng Aug;38(8):

21. Commissure height and deep leaflet cuts minimize leaflet stress
Finite element analysis of the CoreValve® leaflets demonstrate a 12% reduction in stress when compared to traditional valve designs
Areas of high stress can induce collagen degeneration that over time could lead to tearing and valve failure1
Valve designs that reduce leaflet stresses “are likely to have improved performance in long-term applications”2
Finite Element Analysis (FEA) shows how leaflet shape and height can influence leaflet stress:
FEA is a complex computer simulation that factors in material properties and behavior to quantify stresses in a product design. Areas of highest stress are indicated by yellow, orange and red colors, with red being the highest.
In this side by side comparison, we can see how the CoreValve leaflet geometry experiences less stress than a more traditional valve design.
The areas which experience the greatest stresses on the traditional valve include the commissure, the coaptation crease, and the area where the leaflet is sutured to skirt.
Schoen Frederick J. Cardiac Valve Prostheses: Pathological and Bioengineering Considerations. J Cardiac Surg. 1987;2:
Sun W., Li K., Sirois E. Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment. J Biomech. 2010;43:

22. AOA® anti-mineralization treatment reduces both early and late valvular calcification
Alpha-amino oleic acid (AOA®) treatment inhibits calcium formation on prosthetic valve leaflets.
Unlike surfactants, AOA bonds with the tissue to block calcium binding.
AOA has 20 years of proven clinical success on Medtronic’s surgical valves.1
1. Medtronic Freestyle Aortic Root Bioporsthesis was first implanted clinically in August 1992.
INTERNATIONAL. CAUTION:  For distribution only in markets where CoreValve® is approved.  Not for distribution in U.S., Canada or Japan. © Medtronic, Inc. (2012), All Rights Reserved.

23. Potential Complications
Implantation of the CoreValve Transcatheter Valve may include the following risks:
Death including all cause and cardiovascular mortality
Myocardial infarction including coronary occlusion
Stroke including permanent stroke and TIA
Re-intervention including sAVR and repeat valve placement
Aortic regurgitation
Permanent pacemaker placement
Pericardial tamponade (wire perforations)
Vascular and bleeding complications
Valve migration or fracture
For complete list of adverse events, warnings and contraindications reference CoreValve IFU
CoreValve® is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
Evolut™, TruFit™, AccuTrak®, and AOA® are registered trademarks of Medtronic, Inc. 23