MEDICAL EDUCATION ACADEMIA MEDICAL EDUCATION ACADEMIA
COREVALVE® AND EVOLUT® R SYSTEMS OVERVIEW
THE INFORMATION IN THIS DOCUMENT IS INTENDED FOR EDUCATIONAL PURPOSES AND IS NOT MEANT AS A SUBSTITUTE FOR THE INSTRUCTIONS FOR USE OR PRODUCT TRAINING. PRACTICE MAY VARY BASED ON CLINICAL JUDGMENT. INTERNATIONAL. CAUTION: FOR DISTRIBUTION ONLY IN MARKETS
WHERE COREVALVE EVOLUT R HAS BEEN APPROVED. NON DESTINE AU
MARCHE FRANCAIS. ©MEDTRONIC, INC. 2015. ALL RIGHTS RESERVED.
UC201601254a EE April, 2016
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2 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CONSISTENT DESIGN PROVEN IN MORE THAN 130,000 IMPLANTS WORLDWIDE
Self-Expanding Frame
Conforms and seals to the annulus
The foundation for recapturability
Supra Annular Valve Design
Maximize flow and optimize coaptation
Porcine Pericardial Tissue
Thinness for low profile delivery
Strength and pliability for long-term durability
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Superelasticity Performance
Compact designs and low delivery profile
Conformable to patient anatomy
Self-anchoring
Controlled retraction for precise delivery and placement
Maintains valve shape
Highly biocompatible
MR Conditional*
Proven fatigue performance
Shape Retention
3 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
FRAME MATERIAL SELECTION: NITINOL
* Refer to IFU for list of safe operating parameters
MEDICAL EDUCATION ACADEMIA
4 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
SELF-EXPANDING FRAME DESIGN
Frame cells comprised of struts and nodes: Smallest cell accommodates a 10 Fr catheter for coronary access
Nodes appear as bands when compressed into the delivery system and are used to assess valve depth
Nodes
Strut
Cell
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PRODUCT DESIGN:
Conforming Frame The nitinol frame conforms and seals to the non-circular annulus.
Images courtesy of Drs. De Jaegere and Schultz, Erasmus MC, Rotterdam,
The Netherlands
5 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CLINICAL NEED: STRONG HEMODYNAMIC PERFORMANCE MINIMIZING PARAVALVULAR LEAK
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6 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CLINICAL NEED: STRONG HEMODYNAMIC PERFORMANCE MAXIMIZING BLOOD FLOW
PRODUCT DESIGN:
Supra-annular Valve Design
The supra-annular leaflet position optimizes orifice area and flow while preserving circularity and coaptation.
MEDICAL EDUCATION ACADEMIA
7 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
TISSUE SELECTION: PORCINE PERICARDIUM
Porcine pericardium ensures optimal valve performance in a low delivery profile:
Approximately half as thick as bovine pericardium
Prevents tissue damage during loading, crimping, tracking, and deployment
Allows for low-profile delivery across all valve sizes1,2
1. Sacks MS. University of Pittsburgh, 2008. Data on File.
2. Braga-Vilela AS, et al., J Membr Biol. 2008 .
Porcine Pericardium Bovine Pericardium
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PRODUCT DESIGN:
14Fr Equivalent Delivery Profile Across All Evolut R Valve Sizes
The low profile of the CoreValve and Evolut R systems helps minimize trauma during delivery, allowing physicians to treat patients with small or calcified vasculature.
1. Genereux P, et al. Vascular complications after transcatheter aortic valve replacement: insights from the
PARTNER (Placement of Aortic Transcatheter Valve) trial. JACC 2012;60(12):1043-52.
2. Hayashida K, et al. Transfemoral aortic valve implantation. JACC Intv 2011;4(8):851-8.
3. Josep Rodés-Cabau. Next-Generation Balloon-Expandable Technology: SAPIEN 3. TCT 2012
Larger sheath size has been shown to increase
the rate of major vascular complications1
and mortality.2
8 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CLINICAL NEED: LOW PROFILE ACCESS ACCESS THROUGH SMALL OR TORTUOUS ANATOMY
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EVOLUT R SYSTEM
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10 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
DEVICE & PATIENT SELECTION CRITERIA
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11 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
VALVE SIZING
Note: Measurements provided are approximate based on engineering specifications.
Frame Height: 49 mm
Skirt Length: 12 mm
31 mm
23 mm
44 mm
CoreValve 31mm
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The Enveo R Delivery System with 14Fr-Equivalent In-Line Sheath is indicated for vessels down to 5.0 mm
Evolut R DCS
12 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
DELIVERY CATHETER SYSTEMS
The 18 Fr CoreValve Accutrak Delivery system is indicated for vessels down to 6.0 mm
CoreValve DCS
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13 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
LOADED CAPSULE UNDER FLUOROSCOPY
CoreValve
Evolut R
6 mm
Note: Measurements provided are approximate based on engineering specifications.
Capsule Flare 10 mm
Radiopaque Marker Band
Radiopaque Marker Band
4 mm
4 mm
4 mm
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14 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
TARGET IMPLANT DEPTH
CoreValve Evolut R
Target implant depth is 3 - 5 mm
Midway between nodes 0 and 1 to just below node 1
Target implant depth is 4 - 6 mm
Between nodes 1 and 1.5
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Minimum Transarterial Access Vessel Diameters ≥ 5.0 mm
15 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
LOWEST DELIVERY PROFILE 14FR-EQUIVALENT SYSTEM WITH INLINE SHEATH
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94.7% Patients Treated via Transfemoral Access
16 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
LOWEST DELIVERY PROFILE NEARLY ALL PATIENTS TREATED VIA TRANSFEMORAL ACCESS
94.7%
5.3%
Implants by Access Route
Transfemoral Alternative Access
14-Fr Equivalent In-Line Sheath
Evolut R Global Clinical Trial Results (US IFU).
MEDICAL EDUCATION ACADEMIA
17 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CONTROL DURING DEPLOYMENT 1:1 RESPONSE
Shaft ‘Spines’
Cross section of catheter shaft (excluding the stability layer)
Catheter shaft ‘spines’ provide stability to reduce stretching or compressing of shaft to enable 1:1 Response
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Capsule Flare
EnVeo™ R DCS’s capsule flare and flexible catheter design enable uniform and controlled valve expansion and self-centering of the valve in the annulus
18 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CONTROL DURING DEPLOYMENT SELF-CENTERING
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19 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CONTROL DURING DEPLOYMENT SELF-CENTERING
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20 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CONTROL DURING DEPLOYMENT ABILITY TO RECAPTURE AND REPOSITION
EnVeo R DCS provides option to recapture and reposition up to three times before reaching the ‘Point of No Recapture’*
* Up to 80% deployment
Tactile Indicator ~ 2/3 Deployment
Just Prior to Point of No Recapture ~ 80% Deployment*
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21 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
EXCEPTIONAL VALVE PERFORMANCE LOW PPM RATE
1. Accurate Positioning • 1:1 response with the ability to recapture and
reposition the valve
2. More Consistent Radial Force* 3. Atraumatic Inflow
Redesigned inflow to reduce force applied by the inflow tip
13.3% 30 Day New Pacemaker**
*Comparison to CoreValve device **Evolut R Global Clinical Trial
MEDICAL EDUCATION ACADEMIA
22 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
EXCEPTIONAL VALVE PERFORMANCE ENHANCED SEALING
Enhanced Sealing with a More Conformable Frame 1. Increased Oversizing
2. More Consistent Radial Force
3. Extended Sealing Skirt *
Note: images may not be to exact scale and are for illustration purposes only. *CoreValve Evolut R 26 and 29 mm only **Evolut R Global Clinical Trial Results (US IFU).
Evolut R 29 mm
CoreValve 29 mm
6.8% Moderate & 0% Severe PVL**
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23 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
EASE OF USE IMPROVED FRAME RELEASE
Paddle attachment incorporates a nested paddle and pocket mechanism for release
Rounded paddle design provides a reliable release
Metal paddle attachment helps assess paddle detachment under fluoroscopy
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24 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
EASE OF USE ENVEO R PACKAGING
Packaging with Integrated Rinsing and Loading Bowls
Integrated Loading Bath
Removable Rinsing Bowls
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MUCHAS GRACIAS!