Medtronic CoreValve® | CoreValve® Evolut™ Transcatheter Aortic Valves

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

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

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

Anatomical Fit Deliverability Performance & Durability

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

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

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

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

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

Full Range of Valve Sizes

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

Anatomical Fit Deliverability Performance & Durability

AccuTrak® Delivery System AccuTrak® Stability Layer 7cm 15Fr 12Fr 18Fr Over-the-wire 0.035 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

Clinical Experience with AccuTrak Implants at a depth of 4-6 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.

Approved Access Routes Direct Aortic Subclavian Transfemoral

Anatomical Fit Deliverability Performance & Durability

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

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

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, 2008. 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. 2008 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. 2010 Aug;38(8):2690-701.

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;2:65-108. Sun W., Li K., Sirois E. Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment. J Biomech. 2010;43:3085-3090.

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.

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