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INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. CoreValve ® Durability.

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Presentation on theme: "INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. CoreValve ® Durability."— Presentation transcript:

1 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. CoreValve ® Durability and Valve Performance UC c EE INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.

2 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Supra-Annular Valve Medtronic Bioprosthesis Evolution Product Features 12 Mosaic Intact First Generation Second Generation Third Generation 1980’s 1990’s Low/ Zero pressure Toluidine Blue, T6 Flexible stent Physiologic Fixation AOA Flexible Stent Hancock II Hancock MO Freestyle Hancock I * CoreValve High Pressure Fixation Large native muscle bar Flexible Stent Posts Rigid Inflow Supra-Annular Porcine Pericardium Melody Pulmonic Transcatheter Bovine Jugular Bovine Jugular Vein Vein 1970’s INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan.

3 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Hancock II David and colleagues 94% 89.8%

4 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Mosaic ®

5 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Transcatheter Aortic Valves The Durability Challenge How do we go from here………..and never end up hereto here

6 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Valve Durability: A Lesson from Surgical Valves Maintaining Proper Leaflet Motion is Critical to Long Term Valve Durability Leaflet bending/folding during valve operation induces high stresses on leaflets. High bending stresses on leaflets can lead to bending fatigue and potentially delamination, calcification, and/or valve failure 1 Misalignment, leaflet prolapse, asynchrony, poor coaptation, high commissure stress, pinwheeling/bending may lead to early failure. 1. Schoen 1987

7 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Current generation surgical pericardial bioprostheses reveal that these devices can exhibit SVD leading to explant as early as two to four years with continued risk of failure over time 1 Cosgrove D, Lytle B, Taylor P, et al. The Carpentier-Edwards Pericardial Aortic Valve Ten-Year Results. J Thorac Cardiovasc Surg. 1995;110: Roselli E, Smedira N, Blackstone E. Failure Modes of the Carpentier-Edwards Pericardial Bioprosthesis in the Aortic Position J Heart Valve Dis 2006;15: Surgical Pericardial Valve Failures

8 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. CoreValve Design + Tissue Selection = Durability and Performance Porcine pericardium is the optimal tissue for valve performance and low-profile delivery Supra-annular valve design provides optimal leaflet coaptation Commissure height and deep leaflet cuts minimize leaflet stress Self-expanding nitinol frame enhances durability and deliverability AOA ® anti-mineralization treatment reduces both early and late valvular calcification* *AOA anti-mineralization treatment will be available on CoreValve in Fall 2012.

9 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Frame Design Challenges Design RequirementChallenges to Durability Self-anchoring/Migration Material capable of providing appropriate radial force over a range of sizes and shapes Delivery ProfileFrame capable of withstanding crimp profile Span a range of sizes with a single valve and accommodate anatomical variations Frame capable of maintaining structural integrity spanning a range of sizes and shapes Withstand in-vivo loading Frame capable of withstanding multiple modal cycle loading (radial, compression, torsion, etc.)

10 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Frame Fatigue Analysis & Testing Rigorous analysis of CoreValve patient CT datasets provided definition of aggressive boundary condition input for FEA and fatigue tests State of the art finite element (FEA) methods used to predict strain distribution within frame under combined loading modes Frame fatigue testing successfully completed to 600M cycles (15yrs) under multiple test conditions to demonstrate frame durability Combined Loading FEA Enhanced In Vivo Deformation Analysis from CT Data 600M Cycle Frame Fatigue Testing Bench test results shown on this slide and throughout the presentation may not be indicative of clinical performance.

11 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Migration Conduit Development & Testing Patient CT scans are studied to determine the most challenging anatomical conditions for the CoreValve frame Test conduits are developed from materials designed to match the compliance of the human aorta Valves are tested for migration resistance up to stage 3 hypertensive flow conditions

12 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Tissue Design Challenges Design RequirementChallenges to Durability Delivery ProfilePrevent tissue damage during crimping, tracking, and deployment Span a range of sizes with a single valve Preserve long term leaflet function/motion Accommodate anatomical variations Mitigate distortion at the valve level to maintain coaptation alignment and leaflet motion Minimize redundancy that leads to extreme leaflet bending Withstand potential post- implant BAV Post-implant BAV must not damage tissue

13 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Porcine pericardium is the optimal tissue for valve performance and low-profile delivery The ultimate tensile strength (UTS) and suture pull out stresses for porcine and bovine pericardium are statistically equivalent 1,2 Peak physiologic stresses are significantly less than both UTS values 3 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. 1,4 MPa 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, Data on File. 2.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: 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 Aug;38(8): 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 Jan;221(1): Peak Physiologic Stress

14 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. 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 convalently bonds with the tissue to block calcium binding. AOA has 20 years of proven clinical success on Medtronic’s surgical valves. 1 Non-treated TissueAOA® Treated Tissue Tissue Matrix GlutaraldehydeAOABlood CellCalcium Glutaraldehyde preserved tissue The likelihood of calcification increases on nontreated tissues AOA covalently bonds to the free aldehyde groups in the glutaraldehyde tissue AOA reduces both early and late valvular calcification 1. Medtronic Freestyle Aortic Root Bioporsthesis was first implanted clinically in August *AOA anti-mineralization treatment will be available on CoreValve in Fall 2012.

15 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Valve Height Reduces Leaflet Stresses Areas of high stress can induce collagen degeneration that over time could lead to tearing and valve failure 1 Valve designs that reduce leaflet stresses “are likely to have improved performance in long-term applications” 2 12% Lower Stress in the Taller Valve 1.Schoen Frederick J. Cardiac Valve Prostheses: Pathological and Bioengineering Considerations. J Cardiac Surg. 1987;2: Sun W., Li K., Sirois E. Simulated elliptical bioprosthetic valve deformation: Implications for asymmetric transcatheter valve deployment. J Biomech. 2010;43: mm tall 14 mm tall

16 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Finite Element Analysis (FEA) Demonstrates Reduction in Leaflet Stresses Over Traditional Valve Designs mm Hg of Pressure is Applied to Both Valves Max Stress = 1.34 MPa Max Stress = 1.50 MPa 1.Data on file at Medtronic

17 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Supra-Annular Valve Design Can Mitigate Impact of Elliptical or Undersized Deployment Flexible frame conforms to native annulus shape while maintaining bioprosthesis in a higher position Decoupling of valve from native annulus minimizes ellipticity at the valve level 1 1.Data on file at Medtronic

18 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. CoreValve bioprostheses (n=8) were crimped and loaded according to the IFU for 15, 30, 45 and 60 minutes TCV leaflets were inspected under microscope, then removed from the frame and sectioned for histologic analysis Microscopic inspection showed faint imprints that rehydrated quickly during the course of inspection. No evidence of damage was seen on the sutures, leaflets, or skirt tissues Histologic inspection showed mild indents, but these were not correlated to impression sites and were also found on control leaflets Crimping For Up To 60 Minutes Does Not Damage the CoreValve Tissue FM cut MOA section F1 These indents do not correspond to a site of observed imprints FM cut MOA section F2 These indents are in the area of the observed imprints FM cut MOA section F1 These indents do not correspond to a site of observed imprints FM cut MOA section F1 FM cut MOA section F1 These indents do not correspond to a site of observed imprints FM cut MOA section F2 These indents are in the area of the observed imprints FM cut MOA section F2 FM cut MOA section F2 These indents are in the area of the observed imprints

19 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Medtronic has Performed Rigorous Testing to Confirm the Safety of Post-Implant BAV In two separate studies, CoreValve bioprostheses were deployed in synthetic and tissue conduits that were modeled after calcified human aortic anatomy Balloon dilatation was performed using 25mm and 28mm NuMed, Z-Med II balloons at maximum-rated burst pressures for 5 seconds Valves were inspected immediately after removal of the balloon, then assessed for hydrodynamic performance on a pulse duplicator

20 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Post-Implant Balloon Dilatation Does Not Damage CoreValve’s Tissue, Frame, or Sutures Conclusions Inspections showed no evidence of damage to either the valve tissues or assembly sutures in either study The hydrodynamic performance data showed that there was no significant difference in EOA between pre and post balloon dilatation Pre Balloon DilatationPost Balloon Dilatation

21 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Performance Circular DeploymentElliptical Deployment 1.35 aspect ratio Accelerated wear testing (AWT) was performed on 24 valves in both circular and elliptical configurations –Valves were cycled for 200 million cycles (5 years) –Result: Minimal valve wear and low stable gradient and regurgitation levels

22 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. Tissue Integrity Histology performed on leaflet samples after 200 million cycles in an elliptical configuration –All test samples were crimped and loaded into the delivery system prior to wear testing –Leaflets showed no evidence of internal leaflet delamination or collagen loss –Laser-cut free margins were fully intact 1 Figure 3. The pericardial leaflet section is intact Figure 1. Leaflet as receivedFigure 2. Slices submitted for histopathology outflow inflow 1.Data on file at Medtronic

23 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. There have been over 27,000 CoreValve device implants in over 50 countries since the first implantation in 2004 No frame fractures have been reported in an implanted CoreValve device to date In AWT, CoreValve device demonstrated a consistently low regurgitant fraction and stable EOA from base line to post-200 million cycles Long-term (3 and 4-year) durability is indicated by the absence of structural valve deteriorations and sustained hemodynamic performance Conclusions

24 INTERNATIONAL Caution: For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. AOA is a registered trademark of Medtronic, Inc.


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