INTERNATIONAL Caution: For distribution only in markets where CoreValve and CareValve Evolut have been approved. Not for distribution in the USA, Canada,

INTERNATIONALCaution: For distribution only in markets where CoreValve and CareValve Evolut have been approved. Not for distribution in the USA, Canada, or Japan. Non destiné au marché du français.

CoreValve® | CoreValve® Evolut™ 1

Medtronic CoreValve® | CoreValve® Evolut™

Transcatheter Aortic Valves



Clinical Challenges in TAVI

Clinical Need Design ChallengeAccess, 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

ValveLoading System

Delivery System

Self-expanding Nitinol frame with porcine pericardial

valve

True 18Fr catheter delivery system with AccuTrak® stability

layer

Disposable cones and tubes used to

compress the valve



CoreValve and CoreValve Evolut Valves

31mm 29mm 26mm 23mmCoreValve CoreValve Evolut



• Anatomical Fit

• Deliverability

• Performance & Durability



CoreValve Design Legacy

Outflow

Supports valve commissures and enables controlled deployment

Inflow

Conforms and seals to the annulus

Waist

Promotes circularity, supports supra-annular valve

Low Radial Force

High Hoop Strength

High Radial Force



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

1. Data on file at Medtronic Images courtesy of Drs. de Jaegere and Schultz, Erasmus MC, Rotterdam, The Netherlands

Patient 1 Patient 2 Patient 3



Customizes anatomical fit via a tailored height and shape

Optimizes coaptationin non-circular anatomy with supra-annular valve position

Conforms to the anatomy and promotes sealing with optimized interference and radial force

CoreValve EvolutAdds TruFit Technology



CoreValve Evolut Tailored Height and Shape

Preserved skirt length

Provides seal against paravalvular leak

12 mm

45 mm

Reduced height

Reduce height of outflow for better fit, especially in angulated anatomies

Preserved coronary access

Maintains CoreValve cell geometry for coronary access



OptimizedPerformance

More consistent interference and radial force across annular size range while maintaining conformability

CoreValve Evolut Optimized Interference and Radial Force



Full Range of Valve Sizes



Use in failed surgical bioprosthesesNow CE Approved

Large potential orifice area

Leaflets sit above the annulus where the frame is least constrained, opening up the valve for greater flow

Low post-procedural gradients

1. Dvir et al., TCT. Miami, Fl. Oct 2012

1

Surgical Valve

Valve Inflow

Leaflets

CoreValve

Aortic Annulus



• Anatomical Fit

• Deliverability




AccuTrak® Delivery System

Stable Deployment

with AccuTrak Stability Layer

Slow, Controlled Release

with partial repositionability

Low-Profile Access

with true 18Fr profile across all valve sizes

7cmAccuTrak® Stability Layer

Over-the-wire 0.035 compatible15Fr 12Fr 18Fr

6 mm



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 0 (0)

New LBBB 18 (13.4)

New Transient or Sustained AVB

17 (12.7)

New Pacemaker Implantation

12* (10.6)

• 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

*12 of 113 patients without baseline pacemaker.

Clinical Experience with AccuTrak

1. Tchetche, et al., EuroIntervention 2012; e-publication



Approved Access Routes

Direct Aortic Subclavian

Transfemoral



• Anatomical Fit

• Deliverability




Characteristics of Performance

PerformanceClinical Outcomes

Bench Testing

Tissue Treatment

Anti-calcification

Tissue SelectionThickness

Tensile Strength Pliability

Valve DesignLeaflet GeometrySupra-annular



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



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

1. 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.

2. 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.

3. 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.

4. 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.

Thin

Strong

Porcine Pericardium Bovine Pericardium

Porcine pericardium is the optimal tissue for valve performance and low-profile delivery



• 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

1. Schoen Frederick J. Cardiac Valve Prostheses: Pathological and Bioengineering Considerations. J Cardiac Surg. 1987;2:65-108.2. Sun W., Li K., Sirois E. Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment. J Biomech. 2010;43:3085-3090.

Commissure height and deep leaflet cuts minimize leaflet stress

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.

Documents

INTERNATIONAL Caution: For distribution only in markets where CoreValve and CareValve Evolut have been approved. Not for distribution in the USA, Canada,