1. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français. Medtronic CoreValve ® SURTAVI Trial SUrgical Replacement and Transcatheter Aortic Valve Implantation UC201204978b EE

2. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Demonstrate Safety and Efficacy Expand Access to New Populations and Markets Confirm Efficacy and Optimize Practice

3. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Management of Severe Aortic Stenosis in intermediate risk patients CoreValve SURTAVI Trial o o Inclusion Criteria o o Exclusion Criteria o o Study Investigators o o Current Status Comparisons o o US Pivotal Trial and SURTAVI Trial o o SURTAVI Trial and PARTNER II A

4. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Management of Severe Aortic Stenosis in intermediate risk patients CoreValve SURTAVI Trial o o Inclusion Criteria o o Exclusion Criteria o o Study Investigators o o Current Status Comparisons o o US Pivotal Trial and SURTAVI Trial o o SURTAVI Trial and PARTNER II A

5. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial Overview 1 Randomized 1:1, non-inferiority study The trial will be conducted at up to 115 worldwide centers Europe Canada United States Long-term follow-up through 5 years Approximately 2,500 subjects 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

6. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Severe, symptomatic AS Intermediate surgical risk, defined by Society of Thoracic Surgeons (STS) mortality risk of ≥ 4% and ≤ 10% CoreValve ® SURTAVI Trial Patient Population

7. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial Study Design Randomization Stratified by need for revascularization Randomization Stratified by need for revascularization SAVR Medtronic CoreValve ® TAVI N = ~2,500 patients TAVI only TAVI + PCI SAVR only SAVR + CABG STS mortality risk ≥4% and ≤10% STS mortality risk ≥4% and ≤10% Heart Team Evaluation Confirm Inclusion/Exclusion & Intermediate Risk Classification Heart Team Evaluation Confirm Inclusion/Exclusion & Intermediate Risk Classification Baseline Neurological Assessments

8. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Primary Objective and Endpoint Primary Objective Evaluate in a prospective randomized fashion whether TAVI is non-inferior to SAVR with respect to composite endpoint of all-cause mortality and disabling stroke at 24 months in patients with symptomatic severe aortic stenosis and at intermediate surgical risk Primary Endpoint All-cause mortality or disabling stroke at 24-months 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

9. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Secondary Objectives Secondary Objective Assess differences in quality of life, clinical benefit (efficacy endpoints) and health economics in patients with symptomatic severe aortic stenosis and at intermediate risk treated with either Transcatheter Aortic Valve Implantation (TAVI) or Surgical Aortic Valve Replacement (SAVR) Exploratory Objective An analysis will be conducted to determine if patients can be identified as intermediate risk for Transcatheter Aortic Valve Implantation (TAVI) based upon age and the presence of a defined list of co-morbidities commonly associated with patients undergoing TAVI procedures 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

10. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Device and Access Routes CoreValve ® System 23mm, 26mm, 29mm, 31mm Alpha-amino oleic acid (AOA ® ) antimineralization treatment Access Routes Transfemoral Subclavian Direct Aortic 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

11. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Coronary Artery Disease Subjects with CAD and a Syntax score ≤22 will be eligible Concomitant PCI and TAVI can be performed; staging is left at discretion of operator CABG should be conducted during the index SAVR procedure Randomization stratified by need for coronary revascularization

12. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Frailty Assessment Frailty assessments identifies: – –Subject is < 80 years of age and three or more of the following apply – –Subject is ≥ 80 years of age and two or more of the following apply Wheelchair bound Resides in an institutional care facility (e.g. nursing home, skilled care center) Body Mass Index < 20 kg/m 2 Grip strength < 16kg Katz Index Score ≤ 4 Albumin < 3.5 g/dl 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

13. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Management of Severe Aortic Stenosis in intermediate risk patients CoreValve SURTAVI Trial o o Inclusion Criteria o o Exclusion Criteria o o Study Investigators o o Current Status Comparisons o o US Pivotal Trial and SURTAVI Trial o o SURTAVI Trial and PARTNER II A

14. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Inclusion Criteria 1.Subject must have STS mortality risk score of ≥ 4% and ≤ 10% 2.Heart Team consisting of at least one interventional cardiologist and one cardiac surgeon agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

15. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Inclusion Criteria (cont.) 3.Subject has severe aortic valve stenosis presenting with: a)Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm 2 or aortic valve area index < 0.6 cm 2 /m 2 AND b)Mean gradient > 40mmHg or Vmax > 4.0m/sec by resting echocardiogram [or dobutamine stress echocardiogram, if subject has a left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25 4.Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

16. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Inclusion Criteria (cont.) 5.Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits 6.Subject meets the legal minimum age to provide informed consent based on local regulatory requirements 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

17. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Management of Severe Aortic Stenosis in intermediate risk patients CoreValve SURTAVI Trial o o Inclusion Criteria o o Exclusion Criteria o o Study Investigators o o Current Status Comparisons o o US Pivotal Trial and SURTAVI Trial o o SURTAVI Trial and PARTNER II A

18. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Key Exclusion Criteria Subject has refused surgical aortic valve replacement (SAVR) as a treatment option Multivessel coronary artery disease with a Syntax score >22 Extensive mediastinal radiation Liver failure (Child-C) 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

19. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial 1 Key Exclusion Criteria 1 (cont.) Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram Pulmonary Hypertension > 80mmHg Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc 1. Medtronic CoreValve ® SURTAVI Trial. Version 6.0. Mounds View, MN: Medtronic, Inc. Clinical Research; 2013.

20. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Management of Severe Aortic Stenosis in intermediate risk patients CoreValve SURTAVI Trial o o Inclusion Criteria o o Exclusion Criteria o o Study Investigators o o Current Status Comparisons o o US Pivotal Trial and SURTAVI Trial o o SURTAVI Trial and PARTNER II A

21. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial Study Investigators Chairman Prof. P.W. Serruys (Chair) Dr. N. Van Mieghem (Deputy Chair) Principal Investigators Prof. S. Windecker Dr. J. Popma Prof. A.P. Kappetein Dr. D. Adams Prof. R. Lange Dr. M. Reardon Prof. T. Walther

22. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Management of Severe Aortic Stenosis in intermediate risk patients CoreValve SURTAVI Trial o o Inclusion Criteria o o Exclusion Criteria o o Study Investigators o o Current Status Comparisons o o US Pivotal Trial and SURTAVI Trial o o SURTAVI Trial and PARTNER II A

23. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial US Clinical Sites Active Site

24. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Beth Israel Deaconess Medical Center Boston, MA Duke University Medical Center Durham, NC Geisinger Medical Center Danville, PA Iowa Heart Center Des Moines, IA Johns Hopkins Hospital Baltimore, MD Morristown Memorial Hospital Morristown, NJ 1 2 3 7 8 9 4 Pinnacle Health Harrisburg, PA Riverside Methodist Hospital/ Ohio Health Research Institute Columbus, OH Spectrum Health Hospitals Grand Rapids, MI St. Francis Hospital Roslyn, NY St John Hospital and Medical Center Detroit, MI St. Luke's Medical Center/ Aurora Health Care Milwaukee, WI 5 6 10 11 12 CoreValve ® SURTAVI Trial US Clinical Sites - Activated

25. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. The Mount Sinai Medical Center New York, NY The Ohio State University Medical Center/The Richard M. Ross Heart Hospital Columbus, OH University of Kansas Hospital Kansas City, KS University of Michigan Health Systems Ann Arbor, MI University of Pittsburgh Medical Center Pittsburgh, PA University of Southern California Los Angeles, CA Vanderbilt University Medical Center Nashville, TN Wake Forest University/ Baptist Medical Center Winston-Salem, NC 13 18 19 17 14 15 16 20 CoreValve ® SURTAVI Trial US Clinical Sites - Activated (cont.) Baylor Heart & Vascular Dallas, TX 21 22 Hartford Hospital Hartford, CT 23 Methodist DeBakey Heart & Vascular Houston, TX 24 University Hospital/Case Medical Center Cleveland, OH 25 Detroit Medical Center Detroit, MI 26 North Shore University Hospital Manhasset, NY Loyola University Medical Center Maywood, IL 27 28 29 Cardiovascular Institute of the South Houma, LA VA Palo Alto Palo Alto, CA

26. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial US Clinical Sites – Activated (cont.) 32 Fletcher Allen Health Care Burlington, VT NYU-Langone Medical Center New York, NY El Camino Hospital Mountain View, CA Kaiser Permanente Los Angeles, CA Lenox Hill Hospital New York, NY University of Miami Miami, FL Yale New Haven Hospital New Haven, CT Piedmont Heart Institute Atlanta, GA 30 31 33 34 35 36 37 Scripps Green Health La Jolla, CA Washington Hospital Center Washington, DC Columbia University Medical Center New York, NY Good Samaritan Hospital Cincinnati, OH 38 39 40 41

27. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial European Clinical Sites 1 2 3 4 5 6 7 8 10 11 12 13 15 14

28. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Erasmus Medical Center Rotterdam, Netherlands Inselspital - Universitatsspital Bern Bern, Switzerland Leeds General Infirmary Leeds, UK Medisch Centrum Leeuwarden Leeuwarden, Netherlands Righospitalet Copenhagen, Denmark St. Antonius Ziekenhuis Nieuwegein, Netherlands Universitatsspital Zurich Zurich, Switzerland Hospital Universitario Central de Asturias Oviedo, Spain Hospital Universitario Virgen de la Victoria Malaga, Spain CoreValve ® SURTAVI Trial European Clinical Sites - Activated 1 2 3 4 5 6 7 8 9 St. George’s Hospital London, UK Royal Sussex County Hospital Brighton, UK Amphia Hospital Breda, Netherlands Karolinska University Hospital Stockholm, Sweden German Heart Center Munich, Germany University Hospital Bonn, Germany 10 11 12 13 10 14 15

29. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® SURTAVI Trial Canadian Clinical Sites Montreal Heart Institute Montreal, Quebec Royal Victoria Montreal, Quebec University of Ottawa Heart Institute Ottawa, Ontario London Health Sciences Center/ University Hospital London, Ontario Toronto General Hospital Toronto, Ontario 1 2 3 1 2 3 4 4 5 5

30. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Medtronic TAVI Clinical Research Portfolio Management of Severe Aortic Stenosis in intermediate risk patients CoreValve SURTAVI Trial o o Inclusion Criteria o o Exclusion Criteria o o Study Investigators o o Current Status Comparisons o o US Pivotal Trial and SURTAVI Trial o o SURTAVI Trial and PARTNER II A

31. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. Comparison SURTAVI Trial and US Pivotal Trial SURTAVIUS Pivotal Extreme Risk US Pivotal High Risk Patient Population Symptomatic severe AS at intermediate surgical risk: STS mortality risk of ≥4% and ≤10% Symptomatic severe AS, with predicted operative mortality or serious, irreversible morbidity risk of ≥ 50% at 30 days. Symptomatic severe AS, with predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days. Concomitant Coronary Revascularization AllowedExcluded Sample Size ~ 2,500 (adaptive design)1597 (including High Risk)1597 (including Extreme Risk) Geography US, Europe, CanadaUS # of Worldwide Sites 11545 Definition of Severe AS Initial AVA of ≤1.0 cm 2 or AVA index < 0.6 cm 2 /m 2 Initial AVA of ≤ 0.8 cm 2 (or AVA index ≤ 0.5 cm 2 /m 2 ) Primary Endpoint All-cause mortality or disabling stroke at 24 months All-cause death or major stroke at 12 months All-cause mortality at 12 months Neuro Sub-Study Required in primary protocolSeparate sub-study Key Exclusion Criteria Differences True Porcelain Aorta; Extensive Mediastinal Radiation; Liver failure (Child –C); Frailty Assessments; Marfan Syndrome; Uncontrolled AF; Pulmonary HTN; Severe COPD

32. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. SURTAVIPARTNER II A ≥4 and ≤ 10STS Inclusion≥4 >22Syntax Exclusion>32 AVA ≤ 1.0cm 2 Indexed AVA < 0.6 cm 2 /m 2 Valve Area InclusionAVA ≤ 0.8cm 2 Indexed EOA < 0.5cm 2 /m 2 Discharge, 30 days, 3 months, 6 months, 12 months, 18 months, 24 months, annually for 5 years Follow-up VisitsDischarge, 30 days, 6 months, 1 year, annually for 5 years Global (US, Europe, Canada) up to 115 centers GeographyUnited States and Canada (2) (57 centers total) Comparison SURTAVI Trial and PARTNER II A

33. These materials are provided to you strictly for your use in preparing to and participating in the SURTAVI Trial. CAUTION – Investigational device. Exclusively for Clinical Investigations.. ©Medtronic, Inc. 2013. All Rights Reserved. Non destiné au marché français.. CoreValve ® is a registered trademark of Medtronic CV Luxembourg S.a.r.l.