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UC201300969c EN. Through Medtronic sponsored research, the Transcatheter Aortic Valves clinical portfolio is studying over 11,000 subjects at over 125.

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Presentation on theme: "UC201300969c EN. Through Medtronic sponsored research, the Transcatheter Aortic Valves clinical portfolio is studying over 11,000 subjects at over 125."— Presentation transcript:

1 UC201300969c EN

2 Through Medtronic sponsored research, the Transcatheter Aortic Valves clinical portfolio is studying over 11,000 subjects at over 125 clinical sites worldwide, we are committed to providing industry- leading transcatheter therapy clinical research evidence. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

3 Building a Comprehensive Portfolio Demonstrate Safety and Efficacy Expand Access to New Populations and Markets Confirm Efficacy and Optimize Practice These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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5 CoreValve ® ADVANCE Study ADVANCE is a rigorous, fully monitored study of TAVI in the “real world.” 1,015 Subjects intended to be treated with the Medtronic CoreValve System were enrolled at 44 centers (in 12 countries -Western Europe, Asia and South America). All primary endpoints were adjudicated by an independent Clinical Event Committee. In addition, all cerebrovascular events were adjudicated by an independent neurologist. Clinical endpoints reported according to Valve Academic Research Consortium (VARC 1). These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

6 CoreValve ® ADVANCE Study Study Status Active ongoing study Subject Follow-up: ongoing Subjects Enrolled: 1,015 Length Follow-up: 5-years Primary Endpoint Major Adverse Cardiac & Cerebrovascular Events (MACCE) at 30-days post procedure. MACCE defined as a composite of All cause mortality Myocardial Infarction (Q-wave and non-Q-wave) Emergent cardiac surgery or percutaneous re-intervention Stroke Start Enrollment Complete 1-Month6-Month1-Year ADVANCE March 2010 These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

7 CoreValve ® ADVANCE Study High Procedural Success Successful vascular access, delivery & deployment of device & successful retrieval of the delivery system (97.5%) No annular ruptures (0.0%) Valve embolization (0.2%) Conversion to open AVR (0.1%) Coronary compromised (0.1%) Significant Hemodynamic Improvements These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

8 CoreValve ® ADVANCE Study These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc. Primary Endpoint *Kaplan-Meier Estimates

9 CoreValve ® ADVANCE Study These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc. Additional VARC 1 Endpoints *Kaplan-Meier Estimates †New AKI that occurred outside of the 72 hr post-TAVI window are included

10 CoreValve ® ADVANCE Study Low stroke rate out to 1 year These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

11 CoreValve ® ADVANCE Study These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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13 CoreValve ® US Pivotal Trial Evaluate the safety and efficacy of the Medtronic CoreValve ® System in the treatment of symptomatic severe AS in subjects who are at high or extreme risk for aortic valve surgery Randomized open-label study conducted at 45 US sites These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

14 CoreValve ® US Pivotal Trial Study Status Active ongoing study Subject Follow-up: ongoing Subjects Enrolled: ~1575 Length Follow-up: 5-years Primary Endpoints Extreme Risk: All-cause death or major stroke at 12 months (compared to performance goal) High Risk: All-cause mortality at 12 months Start Enrollment Complete 1-Month6-Month1-Year US Pivotal Dec. 2010 Extreme Risk enrollment complete High Risk enrollment complete These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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16 CoreValve ® Continued Access Study Prospective, non-randomized, multicenter study. Enrolling up to 4,500 Subjects from 45 US centers. – 2,250 Extreme Risk – 2,250 High Risk These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

17 CoreValve ® Continued Access Study Study Status Active ongoing study Subjects Follow-up: ongoing Subjects Expected: 4,500 Length Follow-up: 5-years Primary Endpoint Extreme Risk: All-cause mortality or major stroke at 12 months. High Risk: All-cause mortality at 12 months Start Enrollment Complete 1-Month6-Month1-Year CONTINUED ACCESS Feb. 2012 currently enrolling These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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19 Prospective, non-randomized, multicenter study. Enrolling up to 550 Subjects from up to 45 US centers. CoreValve ® Expanded Use Study These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

20 CoreValve ® Expanded Use Study Study Status Active ongoing study Subject Follow-up: ongoing Subjects Expected: 550 Length Follow-up: 5-years Primary Endpoint All-cause mortality or major stroke at 12 months. Start Enrollment Complete 1-Month6-Month1-Year Expanded Use Oct. 2012 currently enrolling These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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22 CoreValve ® SURTAVI Trial Evaluate the safety and efficacy of TAVI in Subjects with severe, symptomatic AS at intermediate surgical risk by randomizing Subjects to either SAVR or TAVI with the Medtronic CoreValve® System Enrolling approximately 2,500 Subjects randomized 1:1 to TAVI and SAVR in up to 75 European, Canadian, and US centers. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

23 CoreValve ® SURTAVI Trial Study Status Active ongoing study Subject Follow-up: ongoing Subjects Expected: ~ 2,500 Length Follow-up: 5-years Start Enrollment Complete 1-Month6-Month1-Year SURTAVI Europe July 2012 US Nov 2012 currently enrolling currently enrolling Primary Endpoint Non-inferiority of combined endpoint of all-cause mortality and major stroke at 24 months. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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25 CoreValve ® ANZ Study Prospective, non-randomized, multicenter study. Enrolling up to 900 Subjects from 10 centers in Australia and New Zealand. Independent Clinical Events Committee to adjudicate all major events Separate DSMB These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

26 CoreValve ® ANZ Study Study Status Active ongoing study Subject Follow-up: ongoing Subjects Expected: 900 Length Follow-up: 2-years Primary Endpoint Cardiac-related Mortality and Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 days. Start Enrollment Complete 1-Month1-Year2-Year ANZ Aug. 2008 currently enrolling These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

27 CoreValve ® ANZ Study High Procedural Success Procedure success was defined as successful implantation of the device, with no death or conversion to surgery (98%) * As of June 29, 2012. Enrollment ongoing. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

28 CoreValve ® ANZ Study * As of June 29, 2012. Enrollment ongoing. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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30 CoreValve ® ADVANCE II Study Characterize current CoreValve System implantation best practices Enrolled 200 Subjects in 9 European centers. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

31 CoreValve ® ADVANCE II Study Study Status Active ongoing study Subject Follow-up: ongoing Subjects Enrolled: 200 Length Follow-up: 6-months Primary Endpoint To determine the incidence of new-onset class I or II indication for Permanent Pacemaker Implantation Start Enrollment Complete 1-Month6-Month1-Year ADVANCE II Oct. 2011 These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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33 CoreValve ® ADVANCE DA Study To further evaluate the clinical benefit of TAVI via direct aortic access using the Medtronic CoreValve® System in Subjects with severe aortic stenosis. Prospective, interventional, single arm, post-market, multicenter study. Enrolling at least 100 Subjects in 13 European centers. Baseline, procedure, discharge, 30- days, 6-months & 12-months. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

34 CoreValve ® ADVANCE DA Study Study Status Active ongoing study Subject Follow-up: not started Subjects Expected: 100 Length Follow-up: 1-year Primary Endpoint All cause mortality at 30-days post procedure Start Enrollment Complete 1-Month6-Month1-Year ADVANCE DA Oct. 2012 currently enrolling These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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36 CoreValve ® Japan Study Study Status Active ongoing study Subject Follow-up: ongoing Subjects Expected: 75 (total) Length Follow-up: 5-years Primary Endpoint Efficacy of the CoreValve system, changes in NYHA, and EOA from baseline to 6 months. Start Enrollment Complete 1-Month6-Month1-Year Japan 26/29 mm Oct. 2011 Japan 23 mm Oct 2011 Currently Enrolling These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

37 CoreValve ® Japan Study Prospective, non-randomized, multicenter study 4 centers in Japan 26mm and 29mm Valve Enrolled 55 Subjects – Iliofemoral, subclavian, and direct aortic access to be studied 23mm Valve Separate study enrolling up to 31 Subjects – Iliofemoral, subclavian, and direct aortic access to be studied These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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39 CoreValve ® CE Pivotal Trial Study Status Complete Subject Follow-up: 3-years Subjects Enrolled : 126 Length Follow-up: 4-years Primary Endpoints Major Adverse Events at 30 days, and technical/procedure success at discharge. Start1-Month6-Month1-Year2-Years CE Pivotal May 2006 These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

40 CoreValve ® CE Pivotal Trial Evaluate the safety and efficacy of the Medtronic CoreValve ® System in the treatment of symptomatic severe AS in subjects who are at high or extreme risk for aortic valve surgery. Nonrandomized, prospective, observational study. 126 Subjects enrolled at 9 centers beginning in May 2006. Data collected at discharge, 30 days, 3 months, 6 months, and annually through 4 years. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

41 CoreValve ® CE Pivotal Trial Beginning Implant Success Technical and procedural success (83.1%) First experiences with the CoreValve device. Functional Class Improvements 80% of Subjects’ functional class improved after TAVI and remained stable out to 2 years. Valve Durability No incidence of structural valve deterioration out to 2 years. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

42 CoreValve ® CE Pivotal Trial Significant Hemodynamic Improvements These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

43 CoreValve ® CE Pivotal Trial Pre-procedural and post-procedural aortic valve regurgitation (AR) These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

44 CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. These materials are provided strictly for you to familiarize yourself with the TAVI clinical research portfolio. CAUTION – Investigational device. Limited by United States law to investigational use. CoreValve is not approved in the USA or Japan. © 2013 Medtronic, Inc.

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