Medtronic Plc. · NYSE:MDT

Medtronic — Investor Presentation (March 2017)

52 slides from Medtronic's investor presentation, March 2017

  1. Slide 1: Cryptogenic Stroke Therapy Awareness Presentation

    CRYPTOGENIC Reveal LINQTM Reveal LINQ Insertable TM Cardiac Monitoring Insertable Cardiac MonitoringSystem System STROKE THERAPY AWARENESS PRESENTATION

  2. Slide 2: Agenda

     Epidemiology  Diagnosis  Guidelines and Evidence to Support Reveal LINQ ICM in Cryptogenic Stroke Patients  Cryptogenic Stroke Care Pathway

  3. Slide 3: Why Talk About Cryptogenic Stroke?

    WHY TALK ABOUT CRYPTOGENIC STROKE? Ischemic Stroke  678,000 ischemic strokes every Large Vessel Small Vessel Other year in the US1 Cryptogenic Stroke Cardioembolic  Leading cause of disability in the US and worldwide  ~200,000 cryptogenic strokes yearly1 20%  Most cryptogenic stroke patients 30%

  4. Slide 4: Risk for Stroke in Patients with AF

    RISK FOR STROKE IN PATIENTS WITH AF 5-FOLD 2X 67% increase in ischemic more likely for decrease in AF patient stroke risk for AF AF-related ischemic stroke risk with oral patients.1 stroke to be fatal as anticoagulants.3 non-AF stroke.2 1 Wolf PA, et al. Arch Intern Med. 1987;147:1561-1564. 2 Lin HJ

  5. Slide 5: Stroke as a Healthcare Issue

    STROKE AS A HEALTHCARE ISSUE ~800,000 87% 5th LEADING CAUSE new or recurrent ischemic; 13% leading cause of of serious long-term disability in the US strokes yearly hemorrhagic death Mozzafarian D, et al. Circulation. 2015;131:e29-e322. 5

  6. Slide 6: Disability Associated with Stroke

    DISABILITY ASSOCIATED WITH STROKE1 100 80 60 Percent 40 50 46 35 20 30 26 26 19 0 Remaining Unable to walk Cognitive deficits Depressive Aphasia Dependent on Institutionalized hemiparesis without assistance symptoms others 1. Go AS, et al. Circulation. 2013;127:e6-e245. 6

  7. Slide 7: Importance of Secondary Ischemic Stroke Prevention

    IMPORTANCE OF SECONDARY ISCHEMIC STROKE PREVENTION Recurrent Stroke Rate among Patients Discharged with a Primary Diagnosis of Stroke, South Carolina, 20021 % (N = 10,399) % 20 18.1 Recurrent Stroke Rate (%) 15 10 8 5 5 0 1.8 1 month 6 months 1 year 4 years 1. Feng W, et al. Neurology. 2010;74:588–5

  8. Slide 8: Definitions of Cryptogenic Stroke

    DEFINITIONS OF CRYPTOGENIC STROKE CLASSIFICATION SCHEME REQUIRED WORK-UP TOAST1 Not specified % Causative Classification Brain CT/MR, 12-lead ECG, of Stroke (CCS)2 precordial echocardiogram, extra/intravascular imaging Embolic strokes of Brain CT/MR, 12-lead ECG, undetermined source3 precordial echo

  9. Slide 9: Cryptogenic Stroke Is a Diagnosis of Exclusion

    CRYPTOGENIC STROKE IS A DIAGNOSIS OF EXCLUSION1 Atherosclerotic Atherosclerotic* Arteroembolic* % Small arterial occlusion Aortoembolic Branch occlusive disease † Cardioembolic Small arterial occlusion Other causes Cardioembolic Paroxysmal atrial fibrillation Paradoxical embolism Cryptogenic Other c

  10. Slide 10: Conventional Monitoring Strategies

    CONVENTIONAL MONITORING STRATEGIES Holter Monitor Event Recorder Mobile Cardiac Telemetry 24-48 hours of monitoring Up to 30 days of monitoring Up to 30 days of monitoring External loop recorder Event-triggered loop recorder Ambulatory event monitor Saves all cardiac Saves events only Saves all card

  11. Slide 11: Studies of Insertable Cardiac Monitors (ICMs)

    STUDIES OF INSERTABLE CARDIAC MONITORS (ICMS)1  Multiple studies have assessed the ability of ICMs to detect AF in patients with cryptogenic stroke  Cotter study  Ritter study 20%  Etgen study 30%  Rojo-Martinez study 30%  SURPRISE Cryptogenic Stroke 15%  CRYSTAL AF 1. Glotzer TV, et al. Hear

  12. Slide 12: Summary of ICM Studies in Cryptogenic Stroke

    SUMMARY OF ICM STUDIES IN CRYPTOGENIC STROKE Study Duration of Definition Time to AF detection rate monitoring of AF Diagnosis (%) (months) (days) Ritter1 10 >30 seconds 64 17 Etgen2 12 >6 minutes 152 27 Cotter3 8 2 minutes 48 25 SURPRISE4 19 >2 minutes 109 16 Rojo-Martinez5 9 2 minutes 102 33 Ziegl

  13. Slide 13: CRYSTAL AF: Study Design and End Points

    CRYSTAL AF1: STUDY DESIGN AND END POINTS  Randomized, controlled clinical trial with 441 patients  Compared continuous, long-term monitoring with Reveal™ ICM vs. conventional follow-up  Assessment at scheduled and unscheduled visits 20%  ECG monitoring performed at the discretion of the site inv

  14. Slide 14: CRYSTAL AF: Study Population

    CRYSTAL AF1: STUDY POPULATION 447 patients were enrolled 6 were excluded  4 did not meet eligibility criteria  2 withdrew consent 441 underwent randomization 221 were assigned to ICM 220 were assigned to control  208 had ICM inserted  220 received standard of care  13 did not have ICM inserted

  15. Slide 15: CRYSTAL AF: Patients

    CRYSTAL AF1: PATIENTS  Age ≥ 40 years  Screening for thrombophilic states (in patients < 55 years of age)  Diagnosis of stroke or TIA occurring within previous 90 days  Magnetic resonance angiography, computerized tomography angiography,  Stroke was classified as cryptogenic or catheter angiogr

  16. Slide 16: CRYSTAL AF: Selected Baseline Patient Characteristics

    CRYSTAL AF1: SELECTED BASELINE PATIENT CHARACTERISTICS ICM Control Characteristic P (n = 221) (n = 220) Age (years) 61.6 ± 11.4 61.4 ± 11.3 0.84 Male 64.3% 62.7% 0.77 White 87.8% 86.8% 0.60 Patent foramen ovale 23.5% 20.9% 0.57 Index event 0.87 Stroke 90.5% 91.4% TIA 9.5% 8.6% 1. Sanna T, et al. N E

  17. Slide 17: CRYSTAL AF: Monitoring with ICM Superior to SOC

    CRYSTAL AF: MONITORING WITH ICM SUPERIOR TO SOC FOR THE DETECTION OF AF1 1. Sanna T, et al. N Engl J Med. 2014;370:2478-2486. 17

  18. Slide 18: CRYSTAL AF: Key Secondary End Point

    CRYSTAL AF1: KEY SECONDARY END POINT 12 97% of patients in whom months AF was detected received oral anticoagulants 1. Sanna T, et al. N Engl J Med. 2014;370:2478-2486. 18

  19. Slide 19: CRYSTAL AF: Median Time to Detection of AF

    CRYSTAL AF1: MEDIAN TIME TO DETECTION OF AF 84 53 Days in the ICM group Days in control group (range 18 to 265 days) (range 17 to 212 days) 1. Sanna T, et al. N Engl J Med. 2014;370:2478-2486. 19

  20. Slide 20: EMBRACE vs. CRYSTAL AF: Different Studies, Different Results

    EMBRACE VS. CRYSTAL AF1,2: DIFFERENT STUDIES, DIFFERENT RESULTS CRYSTAL AF1 EMBRACE2 Inclusion  Age ≥ 40 years  Age ≥ 55 years Criteria  Ischemic stroke or TIA  Ischemic stroke or TIA within within previous 90 days previous 6 months  Stroke classified as  Stroke classified as cryptogenic after

  21. Slide 21: Real World Validation of CRYSTAL AF Results

    REAL WORLD VALIDATION OF CRYSTAL AF RESULTS Rogers, AAN, 2016  1247 real-world cryptogenic stroke 72% of AF patients would be missed patients monitored by Reveal LINQ™ if monitoring stopped at 30 days  Cryptogenic stroke diagnosis: physician’s discretion  Follow-up: 12 months  Diagnostic yield a

  22. Slide 22: Summary: Days to Detection of AF in Clinical Studies of ICMs

    SUMMARY: DAYS TO DETECTION OF AF IN CLINICAL STUDIES OF ICMS1-7 200 150 161 Days from Insertion 100 102 109 84 86 50 64 48 0 Cotter 1 Etgen 2 Ritter 3 Rojo-Martinez4 SURPRISE 5 CRYSTAL AF 6 Real World 7 (2 min) (6 min) (2 min) (2 min) (2 min) (2 min) (2 min) N = 51 N = 22 N = 60 N = 101 N = 85 N = 4

  23. Slide 23: Summary: AF Detection Yield in Clinical Studies of ICMs

    SUMMARY: AF DETECTION YIELD IN CLINICAL STUDIES OF ICMS1-7 50 40 AF Detection Yield (%) 30 33.7 30.0 25.5 27.3 20 16.7 16.1 16.8 10 0 Cotter 1 Etgen 2 Ritter 3 Rojo-Martinez 4 SURPRISE 5 CRYSTAL AF* 6 Real-World 7 (2 min) (6 min) (2 min) (2 min) (2 min) (2 min) (2 min) N = 51 N = 22 N = 60 N = 101 N

  24. Slide 24: Predictors of AF Offer Only Poor Predictive Ability

    PREDICTORS OF AF OFFER ONLY POOR PREDICTIVE ABILITY1 CRYSTAL AF sub-analysis: Thijs, Neurology  Parameters tested:  Age, sex, race  Body Mass Index,  Type and severity of index event  CHADS2 score  PR-interval  Diabetes, hypertension  Congestive heart failure  Patent foramen ovale  Prematu

  25. Slide 25: Continuous Monitoring Is Superior to Intermittent

    CONTINUOUS MONITORING IS SUPERIOR TO INTERMITTENT1 CRYSTAL AF sub-analysis: Choe, Am J Cardiol 2015 Sensitivity was low: 1.3-22.8%  Simulated intermittent monitoring Negative predictive value: 82.3-85.6% was compared to continuous rhythm monitoring in 168 ICM patients “Intermittent rhythm monitorin

  26. Slide 26: Reveal LINQ ICM IIa Recommendation for Cryptogenic Stroke

    REVEAL LINQ™ ICM IIA RECOMMENDATION FOR CRYPTOGENIC STROKE 2016 ESC GUIDELINES FOR THE MANAGEMENT OF AF Recommendation Class Level In stroke patients, additional ECG IIa B monitoring by long-term non- invasive ECG monitors or implanted loop recorders should be considered to document silent atrial fi

  27. Slide 27: Reveal LINQ Is a Cost-Effective Diagnostic Tool

    REVEAL LINQ™ IS A COST-EFFECTIVE DIAGNOSTIC TOOL1 Diamantopoulos, Int J Stroke  Monitoring with and ICM was  Stroke-related costs were reduced in associated with fewer recurrent ICM patients, but overall costs were strokes and increased QALYs higher (quality-adjusted life years) compared to standa

  28. Slide 28: Why Extended Monitoring?

    WHY EXTENDED MONITORING? SHORT- AND INTERMEDIATE-TERM MONITORING MAY MISS MANY PATIENTS WITH PAROXYSMAL AF1 79% of first AF episodes were asymptomatic at 12 months1 Note: For illustrative purposes only. 1. Sanna T, et al. N Engl J Med. 2014;370:2478-2486. 29

  29. Slide 29: Reveal LINQ System Advantages

    REVEAL LINQ™ SYSTEM ADVANTAGES REVOLUTIONIZING CARDIAC MONITORING The smallest, most powerful insertable cardiac monitor One-third the size of a AAA battery (1.2 cc) Up to a 3-year longevity for long-term monitoring1 MR Conditional at 1.5 and 3.0 Tesla Minimally invasive, simplified insertion proced

  30. Slide 30: Reveal LINQ System Advantages: Simple Insertion Procedure

    REVEAL LINQ™ SYSTEM ADVANTAGES SIMPLE INSERTION PROCEDURE Best location: 45 degrees to sternum over 4th intercostal space, 2 cm from left edge of sternum 97% of physicians found the insertion tool simple and intuitive.1 1 Reveal LINQ Usability Study. Medtronic data on file. 2013. 31 Syncope | Therap

  31. Slide 31: TruRhythm Detection Inside: Accuracy Evolution

    TRURHYTHM™ DETECTION INSIDE ACCURACY EVOLUTION TruRhythm™ Detection Reveal LINQ™ Reveal™ XT With FullView ™ Software Reveal™ XT Streamlined episode review for clinic efficiency1,2 NEW Pause algorithm NEW simplified insertion and NEW algorithms with PAUSE with diminishing tight pocket for better sign

  32. Slide 32: TruRhythm Intelligent Detection

    TRURHYTHM™ INTELLIGENT DETECTION NEW ALGORITHMS SMART FILTERING SELF-LEARNING NEW second sensing filter Exclusive fifth-generation analyzes rhythms for possible atrial fibrillation algorithm undersensing in Brady and learns and adapts to Pause patient’s rhythm over time BRADY & PAUSE AF 33

  33. Slide 33: Reveal LINQ ICM System: Proven Arrhythmia Detection

    REVEAL LINQ™ ICM SYSTEM PROVEN ARRYTHMIA DETECTION. INFORMED CLINICAL DECISIONS. 99.7% Reveal LINQ™ ICM is proven to find AF Highest published AF detection accuracy on the market, at 99.7%1 50+ As the most clinically-validated ICM, with 50+ detection performance papers, Reveal LINQ™ ICM is the relia

  34. Slide 34: TruRhythm Proven Detection Confidence Across Indications

    TRURHYTHM™ PROVEN DETECTION CONFIDENCE ACROSS INDICATIONS Cryptogenic Syncope Atrial stroke fibrillation Why Reveal LINQ™ ICM? Why Reveal LINQ™ ICM? Why Reveal LINQ ™ ICM? 88% percent of AF patients 78% of patients with recurrent Short and intermittent would be missed if syncope are diagnosed with a

  35. Slide 35: Clinical Rigor: Evidence Superiority, Real-World Impact

    CLINICAL RIGOR EVIDENCE SUPERIORITY. REAL-WORLD IMPACT. Most Studied Withan With anevidence evidenceportfolio portfolioof of 500+ 500+ published published clinical clinical articles articles andand ICM abstracts abstracts 1 1 Most Clinically AcrossCryptogenic Across Cryptogenic Stroke, Stroke, Synco

  36. Slide 36: Conclusions

    CONCLUSIONS  The more you look, the more you find  Short- to intermediate-term cardiac rhythm monitoring may not be enough to detect paroxysmal AF in your cryptogenic stroke patients  CRYSTAL AF demonstrates superiority of continuous, long-term monitoring of cryptogenic stroke patients with an IC

  37. Slide 37: Ischemic Stroke Work-Up

    ISCHEMIC STROKE STROKE WORK-UP Lacunar infarction: Embolic appearing stroke History of AF? small vessel disease with no history of AF: • Multiple foci of infarction • Cortical watershed Standard stroke distribution Standard stroke work-up • Cerebellar work-up Used with permission from Matthew C. Hol

  38. Slide 38: Cryptogenic Stroke Pathway

    CRYPTOGENIC STROKE PATHWAY Pathway based on the consensus of the Cryptogenic Stroke Pathway steering committee. February 2016. Medtronic Disclosure Statement: This pathway is provided for educational purposes and should not be considered the exclusive source for this type of information. It is the r

  39. Slide 39: Conclusions

    CONCLUSIONS  Approximately one-third of ischemic strokes are classified as cryptogenic, and up to 30% many have previously undiagnosed AF  The more you look, the more you find  Short- to intermediate-term cardiac rhythm monitoring may not be enough to detect paroxysmal AF in your cryptogenic stro

  40. Slide 40: Evidence Summary

    EVIDENCE SUMMARY ICMS FOR AF DETECTION IN CRYPTOGENIC STROKE  ICM detects low burden/asymptomatic AF in cryptogenic stroke patients Etgen’13, Cotter’13, Rojo-Martinez’13, SURPRISE’14  ICM offers higher diagnostic yield than 7-day Holter, Ritter’13 standard monitoring CRYSTAL-AF’14 and intermittent

  41. Slide 41: Conclusions: Clinical Impact

    CONCLUSIONS CLINICAL IMPACT: More Appropriate Care  Reveal™ ICM detected over 7 times more patients with AF compared to standard monitoring at the 12-month end point 20%had AF detected  At 12 months, 97% of patients in the ICM arm who were prescribed OAC  Reveal LINQ™ ICM should be included in al

  42. Slide 42: Cryptogenic Stroke Patient Case Studies

    CRYPTOGENIC Reveal LINQTM Insertable Cardiac Monitoring System STROKE PATIENT CASE STUDIES

  43. Slide 43: Scott's Story

    CRYPTOGENIC STROKE PATIENT IMPACT SCOTT’S STORY Reveal LINQ™ ICM used to discover AF in 22-year-old stroke patient On his way to a soccer game, 22-year-old Scott suddenly began wobbling. His head started throbbing. What he thought was dehydration turned out to be much worse. The college student had

  44. Slide 44: Case Study

    CASE STUDY  51-year-old woman  Episode of unsteady gait and dizziness (< 1 hour)  On admission:  BP 140/86  HR 68 BPM 20%  No neurologic deficits  After urgent MRI, admitted to intensive care unit for further assessment 45

  45. Slide 45: Case Study

    CASE STUDY 46 Medtronic

  46. Slide 46: Case Study

    CASE STUDY  Two areas of infarct were identified in the left cerebellum  MRA of head and neck and chest x-ray returned normal results  TTE showed normal LV size and function 20%  Subsequent TEE confirmed these results, also showed that her atrial size was at the upper limits of normal  TEE show

  47. Slide 47: Case Study

    CASE STUDY  Patient discharged on clopidogrel 75 mg/day and was followed for an additional 14 days with MCT  No arrhythmias identified during this period 48

  48. Slide 48: Case Study

    CASE STUDY  Five weeks after her initial stroke presentation, she developed a recurrence of unsteadiness and dizziness  Patient also developed a right-sided headache with nausea and vomiting  Symptoms lasted 2 hours  Patient was admitted to the ICU after an urgent brain MRI 49

  49. Slide 49: Case Study

    CASE STUDY 50

  50. Slide 50: Case Study Summary

    CASE STUDY SUMMARY  The patient underwent extensive additional evaluation, including a work-up for hypercoagulability, which was negative  She was subsequently implanted with an ICM and discharged on clopidogrel and aspirin  After 2 months of monitoring, episodes of paroxysmal AF lasting 15 to 90

  51. Slide 51: Brief Statement

    BRIEF STATEMENT Reveal LINQ™ LNQ11 Insertable Cardiac Monitor and Patient Assistant Indications Reveal LINQ™ LNQ11 Insertable Cardiac Monitor The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and

  52. Slide 52: Brief Statement (Continued)

    BRIEF STATEMENT (CONTINUED) Medtronic MyCareLink™ Patient Monitor, Medtronic CareLink™ Network and CareLink™ Mobile Application The Medtronic MyCareLink Patient Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices

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