COREVALVE AND EVOLUT R SYSTEMS...
Transcript of COREVALVE AND EVOLUT R SYSTEMS...
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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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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
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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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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.
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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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
EVOLUT R SYSTEM
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MEDICAL EDUCATION ACADEMIA
10 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
DEVICE & PATIENT SELECTION CRITERIA
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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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).
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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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
19 CoreValve and Evolut R Systems Overview | Medtronic - Confidential
CONTROL DURING DEPLOYMENT SELF-CENTERING
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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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
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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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA
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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MEDICAL EDUCATION ACADEMIA MEDICAL EDUCATION ACADEMIA
MUCHAS GRACIAS!