INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011.

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Presentation transcript:

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. Axel Linke University of Leipzig Heart Center, Leipzig, Germany Ulrich Gerckens Gemeinschaftskrankenhaus Bonn, Bonn, Germany Peter Wenaweser University Hospital Bern, Bern, Switzerland Corrado Tamburino Ferrarotto Hospital, University of Catania, Catania, Italy Johan Bosmans University Hospital Antwerp, Antwerp Belgium Stephen Brecker St. George’s Hospital, London, United Kingdom (on behalf of the ADVANCE Investigators) UC EE.

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. Disclosure Statements Axel Linke, MD PI, Medtronic CoreValve ADVANCE Study Medtronic CoreValve Proctor customary travel and expenses only

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. Transcatheter Aortic Valve Implant (TAVI) enables treatment of aortic valve stenosis without open-heart surgery. Balloon-expandable TAVI - superior to standard medical therapy in inoperable patients - non-inferior to surgical AVR in high-risk patients with AS in a randomized controlled trial. Neither balloon-expandable or self expanding TAVI have been studied in a rigorous, monitored, independently adjudicated, ‘real world’ study. CoreValve ADVANCE | Background

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Background Medtronic CoreValve ® System Porcine pericardial tissue valve sutured into a self expanding nitinol frame Supra-annular valve position preserves circularity at level of valve function 18Fr catheter delivery system 3 valve sizes

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Objective The objective of the CoreValve ADVANCE study is to evaluate the safety efficacy clinical outcome according to VARC of percutaneous aortic valve implantation using the Medtronic CoreValve System in consecutive ‘real world’ patients with severe aortic stenosis considered inoperable or high risk for conventional AVR by the local ‘HEART TEAM’.

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Methods 1,015 patients enrolled from March 2010 to July 2011 – –5 year follow-up 44 centers - 12 countries in Western Europe, Asia and South America All centers had conducted at least 40 TAVI procedures prior to the study and had Heart Team in place Clinical endpoints reported according to Valve Academic Research Consortium (VARC)

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Primary Endpoint 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 Clinical endpoints reported according to VARC All-cause and Cardiovascular Mortality Myocardial Infarctions Stroke Life Threatening Bleeding Major Vascular Complications Acute Kidney Injury

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Study Oversight 100% of all Patients were monitored All Primary Endpoint events adjudicated by an Independent Clinical Events Committee (CEC) Consisting of TAVI- experienced Interventional Cardiologists and Cardiac Surgeon All Cerebrovascular events adjudicated by an Independent Neurologist Adjudication of events utilized all available relevant source documents; including neuroimaging and systematic NIH Stroke Scale assessments Core Laboratory Systematic review and assessment of ECG’s and Procedural Angiograms

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Baseline Characteristics

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Procedural Results

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Valve Performance

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Symptom Status

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 30-day Outcomes

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 6-month Survival

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 6-month Survival

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 6-month Survival

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 6-month Stroke

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. Summary and Conclusions The CoreValve ADVANCE study, which is the largest, multicenter, prospective, fully monitored TAVI study, shows that treatment of ‘real world’ inoperable and frail, high-risk patients with the Medtronic CoreValve is: Safe Associated with: an improvement in aortic valve function low stroke and mortality rates at 1 month and 6 months follow-up

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. Thank You CoreValve ADVANCE Study Centers

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 30-day Survival 1. Meredith I.T. 12 Month Results from ANZ CoreValve TAV Study. Presented at: TCT Cribier A. FRANCE II Multicenter TAVR Registry. Presented at: TCT Bosmans J. Belgian TAVI Registry. Presented at: London Valves Moat N.E., et al. JACC. 2011; Petronio AS. Italian Registry. Presented at: EuroPCR 2010.

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc All Rights Reserved. CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. For more information and a complete list of adverse events, warning and contraindications reference CoreValve ® IFU.