Medtronic Plc. · NYSE:MDT

Medtronic — Investor Presentation (November 2017)

30 slides from Medtronic's investor presentation, November 2017

  1. Slide 1: CardioInsight Noninvasive 3D Mapping System

    CARDIOINSIGHT™ NONINVASIVE 3D MAPPING SYSTEM VALUE ACROSS THE CARE CONTINUUM

  2. Slide 2: Overview

    OVERVIEW CARDIOINSIGHT NONINVASIVE 3D MAPPING SYSTEM CardioInsight Introduction  CardioInsight history  Product overview  System workflow  Clinical experience Single Beat Mapping (PVC/VT)  Software features  Clinical experience Mapping Fibrillation (AF/VF)  Software features  Clinical experi

  3. Slide 3: CardioInsight History

    CARDIOINSIGHT HISTORY FIRST NONINVASIVE CARDIAC ELECTRICAL MAPPING SOLUTION 1989 2016 Technology 2015 CardioInsight Concept Company Received Acquired by FDA 510k founded CE Mark Medtronic clearance 1989-2006 2009 2014 2016-2017 2006 2012 2015 1990-2006 Clinical ECVUE 2011-2015 2017 Methodology valid

  4. Slide 4: CardioInsight History: Mapping Vest Evolution

    CARDIOINSIGHT HISTORY FIRST NONINVASIVE CARDIAC ELECTRICAL MAPPING SOLUTION 1st Vest (2006) 2nd Vest (2007-200 9) “Alpha” V est (2009-201 0) “Beta” Vest EC(2010-2012) VUE Vest 2017 CardioInsight™ Mapping Vest 4 CardioInsight Noninvasive 3D Mapping System

  5. Slide 5: The CardioInsight System

    THE CARDIOINSIGHT SYSTEM NONINVASIVE MAPPING THROUGHOUT PATIENT CARE CONTINUUM 252 Electrodes Single use ≤8hrs Amplifier 4 Sizes CardioInsight™ Mapping Vest Workstation  Noninvasive mapping CardioInsight™ Workstation  Visualize arrhythmias prior to treatment  Mobile workstation: Map inside and ou

  6. Slide 6: Noninvasive Mapping Throughout Patient Care Continuum

    NONINVASIVE MAPPING THROUGHOUT PATIENT CARE CONTINUUM 1 Prep patient and apply vest 2 Obtain CT scan for heart-torso geometry 3 Record cardiac signals from vest 4 Select beats and create maps 6 CardioInsight Noninvasive 3D Mapping System

  7. Slide 7: Workflow Review: CT Scan, Acquisition, and Map Creation

    WORKFLOW REVIEW CT SCAN, ACQUISITION, AND MAP CREATION Activities Do Not Require The EP Apply vest on patient CT Scan to define Create and display 3D Record signal data in-lab heart-torso electro-anatomical maps information Fibrillatory Maps Non-Fibrillatory Maps  Phase  Potential  Composite  Ac

  8. Slide 8: CT Scan: Acquire Heart-Electrode Relationship

    CT SCAN ACQUIRE HEART – ELECTRODE RELATIONSHIP CT scan Patient lies in supine position Segmentation algorithms Manually edit geometry Vest included in scan field of view Electrode labeling algorithms 8 CardioInsight Noninvasive 3D Mapping System

  9. Slide 9: Mapping Capabilities

    MAPPING CAPABILITIES CARDIOINSIGHT MAPPING FEATURES  Visualize activation wavefront  Identify arrhythmia chamber and region of interest MAP OUTSIDE EP LAB  Display rotational and focal phase patterns  Compare beat to beat activation changes (sinus, drugs, pacing, arrhythmia) MULTI-CHAMBER MAPPIN

  10. Slide 10: Indications for Use

    INDICATIONS FOR USE CARDIOINSIGHT NONINVASIVE 3D MAPPING SYSTEM The Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. 10 CardioInsight Noninvasive 3D Mapping System

  11. Slide 11: Experience and Technology Evolution

    EXPERIENCE AND TECHNOLOGY EVOLUTION VERSATILE, MULTI-RHYTHM Clinical Experience 36% 17% 16% 11% 9% 5% 5% 2% 294 77 261 601 183 81 28 156 PVC VF CRT AF AT VT WPW Other Technology Cases to date*: 1,681 As of: Dec 1st, 2016 *Medtronic data on file 11 CardioInsight Noninvasive 3D Mapping System

  12. Slide 12: CardioInsight Value Proposition: Patient Segmentation

    CARDIOINSIGHT VALUE PROPOSITION PATIENT SEGMENTATION Clinical Product Patient Value Application Functionality Cohort Proposition  Plan therapy strategy before Idiopathic VT: Localizing entering EP lab  Index (no onset Localization of 6.8 +/- 2 mm  Observed reduction in procedural previous ablatio

  13. Slide 13: Clinical Evidence: Published Studies

    CLINICAL EVIDENCE PUBLISHED STUDIES Summary of Literature Reporting the Use of the ECVUE™ Cardiac Mapping System Total Number Accuracy of Chronic Success Patients, Diagnosis Acute Success Weighted † †† †† Studies Weighted Average Weighted Average Average Persistent Atrial N=283 N/A 76% 79% Fibrillat

  14. Slide 14: Single Beat Mapping

    SINGLE BEAT MAPPING Medtronic Further, Together

  15. Slide 15: Single Beat Map Generation

    SINGLE BEAT MAP GENERATION 1. Record Vest Signals 2. Create and Review Single Beat Maps  Define interval  Allows for visualization of global activation pattern  Capture beat and combine  Identify arrhythmia region of interest with CT  Ability to 3D pace map to confirm source (comparing visually

  16. Slide 16: Case Example #1: Bedside Recorded PVC

    CASE EXAMPLE #1: BEDSIDE RECORDED PVC KANAGARATNAM, ST MARY'S HOSPITAL, LONDON Anterolateral LVOT ECM Method of Localisation of Ectopy20 RVOT LVOT MV TV MV TV PA view PA view Activation map favoring LV Potential map on anterolateral LVOT 16 CardioInsight Noninvasive 3D Mapping System

  17. Slide 17: Case Example #1: 3D Pace Map Match

    CASE EXAMPLE #1: 3D PACE MAP MATCH KANAGARATNAM, ST MARY'S HOSPITAL, LONDON Anterolateral LVOT RVOT RVOT LVOT LVOT MV TV MV TV PA view PA view Potential map of PVC bedside at A/L LVOT 3D Pace map of catheter at A/L LVOT 17 CardioInsight Noninvasive 3D Mapping System

  18. Slide 18: Mapping Fibrillation

    MAPPING FIBRILLATION Medtronic Further, Together

  19. Slide 19: Fibrillation Map Generation

    FIBRILLATION MAP GENERATION 1. Record Vest Signals 2. Create and Review Phase and Composite Maps  Tag interval of interest  Visualize electrical wavefront in phase map*  Capture beat and combined  Review detections in the Composite Map with CT  Identify rotation and foci: chamber and region of

  20. Slide 20: Case Example #2: AF Mapping Workflow

    CASE EXAMPLE #2: AF MAPPING WORKFLOW HAISSAGUERRE, CHU HÔPITAUX DE BORDEAUX 3. Viewed detections in composite map NONIVASIVE MAPPING  Displayed rotational core and phase divergences on the map View Detections 4. Reviewed signals from each detection  Confirmed signals have clear activation sequence

  21. Slide 21: Case Example #3: VF Mapping Workflow

    CASE EXAMPLE #3: VF MAPPING WORKFLOW HAISSAGUERRE, CHU HÔPITAUX DE BORDEAUX 1. Recorded and Mapped Sinus Rhythm 2. Induced and Acquired VF in-lab 3. Created Maps and Reviewed:  Electrogram analysis  Phase maps and activation patterns  Composite Maps Mapped both Sustained and Non- Sustained VF (Pr

  22. Slide 22: CardioInsight Research Areas of Interest

    CARDIOINSIGHT RESEARCH AREAS OF INTEREST For EPs who need more information to develop patient specific strategies for complex arrhythmias  Ability to map non-PV  Value of pre-procedure RE-DO AF detections PVC MAPPING single beat mapping for Mapping Non-PV Demonstrate Value Detections  Two-procedu

  23. Slide 23: Thank You

    THANK YOU Medtronic Further, Together

  24. Slide 24: Clinical Evidence Bibliography

    CLINICAL EVIDENCE BIBLIOGRAPHY Persistent Atrial Fibrillation 1. Haissaguerre M, Hocini M, Shah A, et al. Noninvasive panoramic mapping of human atrial fibrillation mechanisms: a feasibility report. Journal of Cardiovascular Electrophysiology. 2013;24(6):711-717. 2. Lim HS, Denis A, Middeldorp ME, e

  25. Slide 25: Clinical Evidence Bibliography

    CLINICAL EVIDENCE BIBLIOGRAPHY Atrial Tachycardia (cont.) 8. Hocini M, Shah Ashok J, Chaumeil A, et al. Focal Arrhythmia Ablation Determined by High-Resolution Noninvasive Maps: Multicenter Feasibility Study. Journal of cardiovascular electrophysiology. Jul 2015;26(7):754-760. 9. Lindsay BDD, Dubois

  26. Slide 26: Clinical Evidence Bibliography

    CLINICAL EVIDENCE BIBLIOGRAPHY Ventricular Arrhythmias (cont.) 15. Cakulev I, Sahadevan J, Arruda M, et al. Confirmation of Novel Noninvasive High Density Electrocardiographic Mapping with Electrophysiology Study: Implications for Therapy. Circ Arrhythm Electrophysiol. 2013;6(1):68-75. 16. Cakulev I

  27. Slide 27: Clinical Evidence Bibliography

    CLINICAL EVIDENCE BIBLIOGRAPHY Accessory Pathways 23. Cakulev I, Sahadevan J, Arruda M, et al. Confirmation of Novel Noninvasive High Density Electrocardiographic Mapping with Electrophysiology Study: Implications for Therapy. Circ Arrhythm Electrophysiol. 2013;6(1):68-75. 24. Cakulev ITD, Sahadevan

  28. Slide 28: Clinical Evidence Bibliography

    CLINICAL EVIDENCE BIBLIOGRAPHY CRT 29. Eschalier R, Ploux S, Lumens J, et al. Detailed analysis of ventricular activation sequences during right ventricular apical pacing and left bundle branch block and the potential implications for cardiac resynchronization therapy. Heart Rhythm. 1/2015;12(1):137

  29. Slide 29: Clinical Evidence Bibliography

    CLINICAL EVIDENCE BIBLIOGRAPHY CRT (cont.) 36. Ploux SD, Lumens J, Montaudon M, et al. Noninvasive electrocardiographic mapping to improve patient selection for cardiac resynchronization therapy: Beyond QRS duration and left bundle branch block morphology. J. Am. Coll. Cardiol. 2013;61(24):2435-2443

  30. Slide 30: Clinical Evidence Bibliography

    CLINICAL EVIDENCE BIBLIOGRAPHY Adult Congenital 40. S Ernst et al Utility of Noninvasive Arrhythmia Mapping in Patients with Adult Congenital Heart Disease Card Electrophysiol Clin 7 (2015) 117-123. Other 41. Medtronic data on file – K140497 30

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