INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in.

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Presentation transcript:

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Medtronic CoreValve ® System Transcatheter Aortic Valve Replacement of Failed Surgical Bioprotheses UC EE

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Bioprosthetic Market Background Approximately 200,000 surgical aortic valve replacements are performed annually 1. Over the last 10 years, the majority of surgically implanted aortic valves have been bioprosthetic. With a life expectancy of years, and implantation of bioprosthetic valves in younger patients, it is expected that there will be a significant increase in the number of patients requiring redo surgery for failed bioprostheses. 1. Brown JM et al; The Journal of Thoracic and Cardiovascular Surger; V.137; No.1; 1/09; p82

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Role of TAVI Reoperation (redo) is the standard of care for failed bioprosthetic valves. However, for patients who are elderly and have associated comorbidities, redo surgery may not be a viable option. – –Operative mortality for an elective redo aortic valve surgery ranges from 2% to 7%; however, it can increase to 30% in high-risk and non-elective patients 1 – –Risk is especially high for patients who have undergone a previous sternotomy and are typically frail. TAVI provides a minimally invasive alternative to conventional redo surgery. Results up to 1 year show positive outcomes for the use of TAVI in failed surgical bioprostheses Piazza et al.; JACC: CARDIOVASCULAR INTERVENTIONS, VoL. 4, NO. 7, Dvir et al., CirculationAHA. Oct 2012

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Type of Bioprosthetic Valve Failure Categorized as AS, AR or Combined Aortic Stenosis (AS) IndicatorMildModerateSevere Jet Velocity (m/second)Less than > 4.0 Mean gradient (mm Hg)*Less than > 4.0 Valve area (cm 2 )Greater than < 1.0 Valve area index (cm 2 per m 2 )< 0.6 Aortic Regurgitation (AR) Angiographic Grade Color Doppler jet width Central jet, width less <25% of LVOT >Mild but no signs of severe AR Central jet, width > 65% LVOT Doppler vena contracta width (cm)Less than > 0.6 Regurgitant volume (ml/beat)Less than ≥ 60 Regurgitant fraction (%)Less than ≥ 50 Regurtitant orifice area (cm 2 )Less than ≥ 30 Left ventricular size-- Increased 1. Bonow et al; ACC/AHA Practice Guidelines. JACC Vol. 48, No.3, 2006.

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Causes of Valve Failure Piazza et al.; JACC: CARDIOVASCULAR INTERVENTIONS, VoL. 4, NO. 7, 2011

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. VIV Procedure: Pre-case Planning Careful pre-case planning is essential to Valve-in-Valve procedural success Medtronic CoreValve System Procedural Best Practices for Stented UC EE and for Stentless UC EE

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. VIV Procedure: Procedural Tips Balloon predilatation of a stenotic surgical aortic bioprosthesis has not been evaluated. In cases where there is severe stenosis, predilatation of the surgical aortic bioprosthesis may be performed, and the steps used are identical to the native valve predilatation Determine valve positioning relative to the ring – –In stentless – use anatomic or reference markers and/or root injections Avoid too low/ too high implantation* The need for rapid pacing is the same as in a native procedure Assess the risk of coronary occlusion by the surgical valve leaflet 7 Medtronic CoreValve System Procedural Best Practices for Stented UC EE and for Stentless UC EE *Recommended implant depth is 4mm-6mm

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Medtronic Hancock IICE Porcine Medtronic MosaicSt. Jude Biocor Supra Sample Surgical Valves

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Valve Positioning Location of Angiographic Markers in Surgical Valves Varies Markers located in crown Markers located in sewing ring Markers located below sewing ring

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. VIV Procedure: Hemodynamics Gradients measured following VIV procedures are typically higher than gradients observed in native annulus procedures. Higher post- procedural gradients can be attributed to two factors: – –Patient-prosthesis mismatch VIV procedures will not resolve gradients caused by mismatch of the originally implanted surgical valve; however, it will reduce gradients resulting from subsequent failure of that valve. – –Decreased orifice area VIV procedures inherently decrease the aortic valve area (AVA) within the annulus Intra-annular designs further decreasing the aortic valve area. CoreValve maximizes AVA with its supra-annular design; therefore, only the Nitinol frame and skirt rest within the failed surgical valve. 10 Dvir et al., CirculationAHA. Oct 2012

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Valve-in-Valve Studies Multiple studies have produced results showing Valve-in-Valve implantation to be a viable treatment option for extreme and high risk patients. The Global Valve-in-Valve Registry has reported on Valve-in-Valve procedures in more than 460 patients using both the CoreValve bioprosthesis and SAPIEN device in a variety of different degenerative bioprosthetic valves. Two additional studies conducted by Bedogni et al., and Linke et al., evaluated CoreValve in Valve-in-Valve procedures with 25 and 27 patients respectively.

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Global Valve-in-Valve Registry Overview: Retrospective collection of data; 38 centers from Europe, North America, Australia, New Zealand and the Middle East. The CoreValve 26mm & 29mm and Sapien 23mm & 26mm devices were used in this study. Purpose: To evaluate the efficacy and safety of ViV procedures 12 Dvir et al., CirculationAHA. Oct 2012 Objectives: Examine clinical outcomes Evaluate results of ViV procedures performed inside bioprostheses types Give correlates for high post-procedural gradients Supply data on possible rare complications Compare procedural characteristics and clinical results of performing Valve in Valve between SAPIEN and CoreValve Note: This study was physician initiated and not supported by Medtronic

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Global Valve in Valve Registry Design Patients undergoing ViV procedures in 55 sites in Europe, Northa-America, Australia, New Zealand and the Middle-East (n=566) Regurgitation (n=139) Regurgitation (n=139) Combined** (n=139) Combined** (n=139) Stenosis (n=182) Stenosis (n=182) Aortic VIV procedures* (n=460) 18 patients enrolled after data lock (September 10 th 2012) were not analyzed Isolated Mitral VIV / ViR (n=88) Isolated Mitral VIV / ViR (n=88) * Including 3 cases of combined aortic VIV and mitral VIV. ** At least a moderate degree of both stenosis and regurgitation while both mechanisms are comparable in their severity.

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Baseline Demographics Stenosis n= 182 Regurgitation n= 139 Combined n= 139 p Value Age (yrs)78.8± ± ± Gender (% male) LogEuroSCORE32.3 ± ± ± STS score (%)12.3 ± ± ± Diabetes Mellitus (%) <0.001 Peripheral Vascular Disease (%) Chronic Renal Failure (%) Previous stroke (%) Dvir et al., TCT. Miami, Fl. Oct 2012

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Procedural Outcomes High Procedural Success Procedural Results Total (n=202) CoreValve (n=124) SAPIEN (n=78)p Value Procedural Success188 (93.1%)120 (96.8%)68 (87.2%) nd TAVR Valve17 (8.4%)10 (8.1%)7 (9%)0.82 Coronary obstruction7 (3.5%)4 (3.2%)3 (3.8%)1.0 Emergent surgery4 (2%)1 (0.8%)3 (3.8%)0.3 Post-implantation BAV25 (12.4%)21 (16.9%)4 (5.1%)0.01 Dvir et al., CirculationAHA. Oct 2012

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Procedural Outcomes 30-Day Outcomes Total (n=202) CoreValve (n=124) SAPIEN (n=78)p Value Death17 (8.4%)9 (7.3%)8 (10.3%)0.45 Major Stroke4 (2%)2 (1.6%)2 (2.6%)0.64 Death or Major Stroke20 (10.4%)11 (8.9%)9 (11.5%)0.48 Major Vascular Complication 7 (3.5%)2 (1.6%)5 (6.4%)0.11 Permanent pacemaker15 (7.4%)11 (8.9%)9 (11.5%)0.48 Mean gradients (mmHg)15.9 ± ± ± 9.2< Dvir et al., CirculationAHA. Oct 2012

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Global Valve-in-Valve Registry Survival Dvir et al., CirculationAHA. Oct 2012 Note: the chart reflects results including both CoreValve and Sapien.

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Improvements in AV area, mean gradients, and regurgitation in Valve in Valve procedures Global Valve-in-Valve Registry Results 18 Note: the chart and graph reflect results including both CoreValve and Sapien. Dvir et al., TCT. Miami, Fl. Oct 2012 AV Area (cm 2 ) AV Mean Gradients (mmHg) Baseline Post- Procedure Baseline Post- Procedure Stenosis (n=182) 0.70 ± ± ± ± 9.8 Regurgitation (n=139) 1.48 ± ± ± ± 6.7 Combination (n=139) 0.91± ± ± ± 8.3 p value < <0.001

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Global Valve-in-Valve Registry Hemodynamic Results Dvir et al., TCT. Miami, Fl. Oct 2012

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Large potential orifice area Leaflets sit above the annulus where the frame is least constrained, opening up the valve for greater flow 25% larger Potential Orifice Area than SAPIEN XT CoreValve Design Improves Hemodynamics in Valve-in-Valve Implantation 1.Dvir et al., TCT. Miami, Fl. Oct Medtronic Data on File. Comparison between CoreValve and SAPIEN XT in surgical bioprosthesis

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Global Valve-in-Valve Registry Predictors of High Post-Procedural Gradient Dvir et al., CirculationAHA. Oct 2012

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Additional Valve-in-Valve Studies Linke et al (n=27) Bedogni et al (n=25) Procedural Success100% Mean Gradient at 30 Days13 ± ± 8.5 Survival at 30 Days92.6%88% Survival at 1 Year88%N/A* New Pacemaker Implantation 3.7%12% 1.Linke et al., Circ Cardiovasc Interv. Oct Bedogni et al., Cardiovascular Interventions. Vol.4.no.11, 2011 *Survival at 6 months was 84% Low gradient, high procedural success and high survival rates were also observed in two additional studies analyzing CoreValve in valve-in-valve procedures.

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Medtronic Hancock IIMedtronic Mosaic Supra-Annular Valve Function in VIV

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. Summary Studies have shown that Valve-in-Valve as a treatment for patients suffering from a failed bioprosthesis is feasible, safe and clinically effective. Pre-case planning is critical to procedural success. Post-procedural gradients in Valve-in-Valve procedures are usually higher than in native aortic valve repair. CoreValve has been shown to have lower post- procedural gradients than competitive TAVI devices.

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, or Japan. Non destiné au marché francais. The information in this document is intended for educational purposes and is not meant as a substitute for Instructions for Use or product training. Practice may vary based on clinical judgment. CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. All other marks are registered by their respective owners. For more information and a complete list of adverse events, warning and contraindications reference CoreValve IFU.