Tech concepts gerckens pcr 2011

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  • The CoreValve PAV was designed specifically for percutaneous implantation. Non-cylindrical frame design incorporates three discrete levels into a single construct and exhibits three separate diameters and three completely different degrees of radial and hoop strength. The inflow portion of the frame exerts higher radial force to ensure secure anchoring in the native aortic annulus. The compliant nature and constant outward force from the self-expanding frame conforms to the patient annulus while maintaining a sealing surface that minimizes paravalvular leak. The center portion of the frame is designed to resist size and shape deformation that is seen. The radial force characteristics of the frame act to decouple the valve from distortion in the annular region The valve leaflets of the bioprosthesis are suprannular. Additionally, the concave design allows for blood flow to the coronary arteries. The outflow portion exerts only low radial force in order to accommodate the ascending aorta. The primary purpose of the outflow portion is to assure optimal flow-orientation.
  • In addition to porcine pericardium’s inherent durability qualities, CoreValve also incorporates two important design features to reduce bending stresses and ensure long term performance and durability: Optimized leaflet geometry Supra-annular valve location
  • Maintaining circularity is allows CoreValve to maintain leaflet coaptation despite inflow ellipticity: As ellipticity increases, leaflets typically experience increased prolapsing, buckling, and pinwheeling. This excess bending and buckling can cause increased stresses that may lead to leaflet tearing and potential valve failure. This image shows a CoreValve valve deployed in both a circular and elliptical deployment; in the elliptical deployment, CoreValve maintains complete leaflet coaption with little to no increase in bending or buckling.
  • Any tool, accessory or technology that can potentially improve the procedure

Transcript

  • 1. Early Design Concepts
  • 2. CoreValve Design Inflow Portion (with skirt) Constrained Portion (with valve leaflets) Outflow Portion
    • Intra-annular anchoring
    • Conforms to native annulus
    • Minimizes paravalvular aortic regurgitation
    • Supra-annular leaflet function
    • Designed to avoid coronaries
    • Sits in ascending aorta
    • Provides PAV alignment
    High Hoop Strength Low Radial Force High Radial Force
    • Frame: Self-expanding laser-cut Nitinol
    • Bioprosthesis: Single layer of porcine pericardium sutured to the frame in a tri-leaflet configuration
  • 3. Valve and Tissue Optimization to Reduce Stress Leaflet Geometry 17 mm Deep cut to lengthen free margin Extra height increases coaptive surface area Valve designs that reduce leaflet stresses “are likely to have improved performance in long-term applications” 2 Length of commissures reduces stress
  • 4. Supra annular location enables CoreValve to maintain coaptation in elliptical deployment
    • CoreValve commissure section minimizes redundancy and excess bending of the leaflets by mitigating inflow ellipticity 1
    1 Medtronic, data on file.
  • 5. Minimizing Valve Ellipticity Helps Maintain Proper Leaflet Coaptation
    • Minimizing valve ellipticity minimizes leaflet prolapsing, buckling, and pinwheeling frequently observed in elliptical valve deployments 1
    Circular Deployment Elliptical Deployment (22mm x 30 mm)
    • Data on file at Medtronic
  • 6. Near Term Developments
  • 7. Enable Multiple Access Routes TransFemoral SubClavian TransApical TransAortic MITRAL VALVE PULMONARY VALVE AORTIC VALVE (by approach)
  • 8. Delivery Profiles 24 FR 22 FR 20 FR 18 FR 16 FR CoreValve Further Decreasing Delivery Profile
  • 9. Continued Future Advances CoreValve Resheath Shaft Flare Recapture and Repositioning Anti-Mineralization Treatment
  • 10. Delivery System Enhancements Simplify Valve Loading Sheath & catheter length modification depending on procedure approach Ergonomic Handle Design
  • 11. Next Generation TAVI High Risk & Inoperable Patient Segments Moderate Risk sAVR Failed Bioprosthesis Design Targets Advanced 10yr+ Durability AR/PVL < 1+ Reduced Heart Block < 10% Ease of Use 16Fr Profile Fully Repositionable Bicuspid Patients 24 Fr 22 Fr 18 Fr 16 Fr
  • 12. Engager™ Technology: Transapical TAVI Solution Scalloped bovine pericardial leaflets Dedicated commissure posts Arms positioned over native leaflets Self-expanding nitinol frame Polyester skirt
    • Developed from the Ventor acquisition
    • Feasibility study in fall 2009
    • CE mark pivotal trial to start soon
    • True over the wire delivery system providing Flexibility for Better Co-axial Positioning
    • Integrated device removing the need for separate introducer
    • Partially repositionable/ recapturable system prior to commissure deployment
  • 13. Imaging Advancements
  • 14. Education Imperative
  • 15. Improved Outcomes through Whole Procedure Approach Vascular Complications Stroke Cardiac Tamponade Aortic Regurgitation TAVI Product Solutions Education & Procedural Improvements Ancillary Tools Sheaths Access Ports Closure Embolic Protection Wires Catheters Balloons
  • 16. Advance Procedural Outcomes Improving procedure Skin to Skin Reduce Embolic Events Prepare Landing Zone; Reduce PVL Reduce Vascular Complications Imaging to Aid Valve Positioning and Sizing Reduce Perforations Percutaneous Pacing
  • 17. Pulmonic Valve Expanding possibilities for Congenital Patients Pulmonary Valve for Native Right Ventricular Outflow Tract (RVOT) PA RV