international caution: for distribution only in markets where corevalve and carevalve evolut have...
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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
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™ 2
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
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CoreValve® | CoreValve® Evolut™ 3
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
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CoreValve® | CoreValve® Evolut™ 4
CoreValve and CoreValve Evolut Valves
31mm 29mm 26mm 23mmCoreValve CoreValve Evolut
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CoreValve® | CoreValve® Evolut™ 5
• Anatomical Fit
• Deliverability
• Performance & Durability
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CoreValve® | CoreValve® Evolut™ 6
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
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CoreValve® | CoreValve® Evolut™ 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
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
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CoreValve® | CoreValve® Evolut™ 8
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
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CoreValve® | CoreValve® Evolut™ 9
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
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CoreValve® | CoreValve® Evolut™ 10
OptimizedPerformance
More consistent interference and radial force across annular size range while maintaining conformability
CoreValve Evolut Optimized Interference and Radial Force
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CoreValve® | CoreValve® Evolut™ 11
Full Range of Valve Sizes
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CoreValve® | CoreValve® Evolut™ 12
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
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CoreValve® | CoreValve® Evolut™ 13
• Anatomical Fit
• Deliverability
• Performance & Durability
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™ 14
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
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™ 15
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
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CoreValve® | CoreValve® Evolut™ 16
Approved Access Routes
Direct Aortic Subclavian
Transfemoral
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CoreValve® | CoreValve® Evolut™ 17
• Anatomical Fit
• Deliverability
• Performance & Durability
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™ 18
Characteristics of Performance
PerformanceClinical Outcomes
Bench Testing
Tissue Treatment
Anti-calcification
Tissue SelectionThickness
Tensile Strength Pliability
Valve DesignLeaflet GeometrySupra-annular
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CoreValve® | CoreValve® Evolut™ 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
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™ 20
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
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CoreValve® | CoreValve® Evolut™ 21
• 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.
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™ 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.