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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. Axel Linke University of Leipzig Heart Center, Leipzig, Germany Johan Bosmans University Hospital Antwerp, Antwerp Belgium Ulrich Gerckens Gemeinschaftskrankenhaus Bonn, Bonn, Germany Peter Wenaweser University Hospital Bern, Bern, Switzerland Corrado Tamburino Ferrarotto Hospital, University of Catania, Catania, Italy Stephen Brecker St. George’s Hospital, London, United Kingdom (on behalf of the ADVANCE Investigators) UC201300511 EE
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. It has been shown that the female gender is an independent predictor of survival in patients over 79 years undergoing surgical aortic valve replacement (SAVR) 1. Female patients represent approximately 50% of the patient population treated with transcatheter aortic valve implantation (TAVI). Limited evidence has been published on the clinical benefits of TAVI by gender. ADVANCE | Background 1 Fuchs C. Heart. 2010.
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. CoreValve ADVANCE Study Objective – 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’. Gender Objective – To evaluate the gender differences in outcomes. ADVANCE | Objectives
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 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 VARC As-treated analysis
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 100% of all Patients were monitored All Primary Endpoint events adjudicated by an Independent Clinical Events Committee 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 ECGs and procedural angiograms ADVANCE | Study Oversight
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Baseline Characteristics
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Baseline Characteristics
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Valve Performance
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Symptom Status
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | 30-day Outcomes
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | 6-Month Survival
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | 6-Month Survival
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | 6-Month Stroke
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. Females receiving Medtronic CoreValve System are significantly older, have higher mean/peak gradients, and are prescribed less cardiovascular medications. Females experienced more strokes and TIAs, major vascular complications, and major bleeding events. However, despite these differences females benefited the same as males from CoreValve with regard to improved hemodynamics and reduced symptoms. Low mortality was reported for both genders out to 6-months. Summary & Conclusions
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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. 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.
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