Medtronic Plc. · NYSE:MDT

Medtronic — Investor Presentation

58 slides from Medtronic's investor presentation

  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

    AGENDA  Epidemiology  Diagnosis & Monitoring Strategies  Evidence  Guidelines  Reveal LINQ™ System  Cryptogenic Stroke Care Pathway  Patient Case Study

  3. Slide 3: Epidemiology

    EPIDEMIOLOGY Medtronic Further, Together

  4. Slide 4: Stroke as a healthcare issue in Europe

    STROKE AS A HEALTHCARE ISSUE IN EUROPE THE LEADING STROKE 1.6 MILLION CAUSE OF DISABILITY IN ADULTS IS THE 2 ND STROKES MOST OCCUR COMMON EACH YEAR CAUSE OF DEATH Wilkins E, Wilson L, Wickramasinghe K, et al. European Cardiovascular Disease Statistics 2017 edition. Eur Heart Network 2017:192 4 Crypt

  5. Slide 5: Disability associated with stroke

    DISABILITY ASSOCIATED WITH STROKE 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 Go AS, et al. Circulation. 2013;127:e6-e245. 5 Cryptogenic Stroke Therapy Awar

  6. Slide 6: Recurrent stroke rate among discharged stroke patients

    RECURRENT STROKE RATE AMONG PATIENTS DISCHARGED WITH A PRIMARY DIAGNOSIS OF STROKE 20 % % 18.1 Recurrent Stroke Rate (%) 15 10 8 5 5 0 1.8 1 month 6 months 1 year 4 years Feng W, et al. Neurology. 2010;74:588–593. 6 Cryptogenic Stroke Therapy Awareness

  7. Slide 7: Atrial fibrillation is a common risk for stroke

    RISK FOR STROKE IN PATIENTS WITH AF ATRIAL FIBRILLATION IS A COMMON ARRHYTHMIA THAT MAY BE AT THE ORIGIN OF A STROKE 7 Cryptogenic Stroke Therapy Awareness

  8. Slide 8: 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 AF DETECTION AND TREATMENT MATTERS 1 Wolf PA, et al. Arch Inter

  9. Slide 9: Why talk about cryptogenic stroke?

    WHY TALK ABOUT CRYPTOGENIC STROKE?  Despite an excessive diagnostic Ischemic Stroke Large Vessel Small Vessel Other workup, about 30% of the stroke Cryptogenic Stroke Cardioembolic patients are still cryptogenic1-6  Most cryptogenic stroke patients receive anti-platelet for secondary 20% preventio

  10. Slide 10: Diagnosis & Monitoring Strategies

    DIAGNOSIS & MONITORING STRATEGIES

  11. Slide 11: Definitions of cryptogenic stroke

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

  12. Slide 12: Cryptogenic stroke is a diagnosis of exclusion

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

  13. Slide 13: Conventional monitoring strategies

    CONVENTIONAL MONITORING STRATEGIES Bedside Holter Event Monitoring Monitor Recorder During Stroke Unit or 24 hours to 7 days of Up to 30 days of monitoring Intensive Care Unit stay monitoring Event-triggered recording External loop recorder Event-triggered loop recorder available Optional storage of

  14. Slide 14: Reveal LINQ with TruRhythm: the long-term monitoring solution

    REVEAL LINQ™ WITH TRURHYTHM ™ THE LONG-TERM MONITORING SOLUTION 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 procedur

  15. Slide 15: Evidence

    EVIDENCE Medtronic Further, Together

  16. Slide 16: CRYSTAL-AF study design and end points

    CRYSTAL-AF STUDY 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  ECG monitoring performed at the discretion of the site inv

  17. Slide 17: CRYSTAL-AF study population

    CRYSTAL-AF STUDY 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 inser

  18. Slide 18: CRYSTAL-AF patient inclusion criteria

    CRYSTAL-AF STUDY PATIENT INCLUSION CRITERIA  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 cryptogen

  19. Slide 19: CRYSTAL-AF selected baseline patient characteristics

    CRYSTAL-AF STUDY 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% Source: Sanna T, e

  20. Slide 20: CRYSTAL-AF AF detection rate

    CRYSTAL-AF STUDY AF DETECTION RATE CONTINUOUS MONITORING WITH REVEAL ICM IS SUPERIOR TO SOC FOR THE DETECTION OF AF IN CRYPTOGENIC STROKE PATIENTS Source: Sanna T, et al. N Engl J Med. 2014;370:2478-2486. 20 Cryptogenic Stroke Therapy Awareness

  21. Slide 21: CRYSTAL-AF learnings

    CRYSTAL-AF STUDY LEARNINGS 84 79% 88% DAYS of first AF episodes were of patients who had AF would have is the median time asymptomatic at been missed if only to AF detection in 12 months monitored for cryptogenic stroke 30 days* patients *Based on Kaplan Meier estimates. (12 months endpoint) Source:

  22. Slide 22: Comparison of short-term monitoring and ICMs

    CRYSTAL-AF STUDY COMPARISON OF SHORT-TERM MONITORING AND ICMS 79% of first AF episodes were asymptomatic at 12 months1 SHORT- AND INTERMEDIATE-TERM MONITORING MAY MISS MANY PATIENTS WITH PAROXYSMAL AF Note: For illustrative purposes only. 1 Sanna T, et al. N Engl J Med. 2014;370:2478-2486. 22 Crypto

  23. Slide 23: CRYSTAL-AF clinical impact

    CRYSTAL-AF STUDY CLINICAL IMPACT CLINICAL IMPACT: MORE APPROPRIATE CARE Short-term cardiac monitoring is NOT sufficient for AF detection in cryptogenic stroke  Extensive external monitoring only found few patients with AF: - In the control group at 6 months, only 3 patients were found to have AF. -

  24. Slide 24: Summary of ICM studies in cryptogenic stroke

    SUMMARY OF ICM STUDIES IN CRYPTOGENIC STROKE Study Duration of Definition of Time to AF detection monitoring AF Diagnosis rate (%) (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

  25. Slide 25: Real world validation of CRYSTAL AF results

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

  26. Slide 26: Long-term detection of AF with ICMs in real-world population

    LONG-TERM DETECTION OF ATRIAL FIBRILLATION WITH INSERTABLE CARDIAC MONITORS IN A REAL-WORLD CRYPTOGENIC STROKE POPULATION Ziegler et al., 2017  1247 cryptogenic stroke patients in the DiscoveryLink database  Follow-up: up to 2 years (579 ± 222 days)  AF ≥2 min was detected in 16.3% at 1 year and

  27. Slide 27: Predictors of AF offer only poor predictive ability

    PREDICTORS OF AF OFFER ONLY POOR PREDICTIVE ABILITY 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  Premature

  28. Slide 28: Continuous monitoring is superior to intermittent

    CONTINUOUS MONITORING IS SUPERIOR TO INTERMITTENT CRYSTAL AF sub-analysis: Choe, Am J Cardiol 2015 Simulated intermittent monitoring Sensitivity was low: 1.3-22.8% was compared to continuous rhythm Negative predictive value: 82.3-85.6% monitoring in 168 ICM patients 100 80 Negative Predictive Value

  29. Slide 29: Detection of AF in ESUS patients

    DETECTION OF AF IN ESUS PATIENTS Israel C. et al, Thromb Haemost. 2017 Oct  123 ESUS patients with ICM DEFINITION OF ESUS  Mean follow-up for 12 months Imaging showing embolic infarction  Average time between stroke and implant: Ultrasound of brain-supplying arteries 20 days Routine ECG  Interro

  30. Slide 30: Summary: days to detection of AF in clinical studies

    SUMMARY: DAYS TO DETECTION OF AF IN CLINICAL STUDIES OF ICMS 200 150 161 Days from Insertion 100 109 112 108 102 84 50 64 48 0 Cotter Etgen Ritter Rojo-Martinez SURPRISE CRYSTAL AF Real World Israel 2 7 8 (2 min) 1 (6 min) (2 min) 3 (2 min) 4 (2 min) 5 (2 min) 6 (2 min) (2 min) N = 51 N = 22 N = 60

  31. Slide 31: Summary: AF detection yield in clinical studies of ICMs

    SUMMARY: AF DETECTION YIELD IN CLINICAL STUDIES OF ICMS 50 40 AF Detection Yield (%) 30 33.7 30.0 25.5 27.3 20 23.6 21,5 16.7 16.1 10 0 Cotter 1 Etgen 2 Ritter 3 Rojo-Martinez SURPRISE CRYSTAL 6AF* Real-World Israel 4 5 7 8 (2 min) (6 min) (2 min) (2 min) (2 min) (2 min) (2 min) (2 min) N = 51 N = 2

  32. Slide 32: Guidelines

    GUIDELINES Medtronic Further, Together

  33. Slide 33: 2016 ESC AF Guidelines

    2016 ESC AF GUIDELINES  Actual ESC guidelines on the diagnosis and management of AF  European Stroke Organization endorsed these guidelines Kirchhof P, et al. Eur Heart J. 2016 Aug 27. pii: ehw210. 33 Cryptogenic Stroke Therapy Awareness

  34. Slide 34: 2016 ESC AF Guidelines: ICM recommendation for cryptogenic stroke

    2016 ESC AF GUIDELINES ICM RECOMMENDATION FOR CRYPTOGENIC STROKE RECOMMENDATION CLASS LEVEL In stroke patients, additional ECG monitoring by IIa B long-term non- invasive ECG monitors or implanted loop recorders should be considered to document silent atrial fibrillation. Classes of Definition Sugge

  35. Slide 35: Reveal LINQ System

    REVEAL LINQ™ SYSTEM Medtronic Further, Together

  36. Slide 36: 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 Requires minimal procedure time and clinical resources 1 Reveal LINQ™ Usability

  37. Slide 37: 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

  38. Slide 38: 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 patient’s Pause rhythm over time BRADY & AF PAUSE 38 Cryptogen

  39. Slide 39: Reveal LINQ ICM system: proven arrhythmia detection

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

  40. Slide 40: 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 an

  41. Slide 41: Clinical rigor: evidence superiority, real-world impact

    CLINICAL RIGOR EVIDENCE SUPERIORITY. REAL-WORLD IMPACT. Most With an evidence portfolio of 500+ published clinical articles and Studied abstracts1 ICM With an evidence portfolio of 500+ published clinical articles and abstracts1 Most Across Cryptogenic Stroke, Syncope, and Atrial Fibrillation Clinic

  42. Slide 42: Reveal LINQ ICM system: an advanced monitoring solution

    REVEAL LINQ™ ICM SYSTEM AN ADVANCED MONITORING SOLUTION Reveal LINQ™ ICM Wireless MyCareLink™ Cellular CareLink Network with TruRhythm™ Patient Monitor & Reports SOLUTION ENABLERS Insertion Tools Patient Assistant LINQ™ Mobile Manager FOCUSON™ App-based programmer Monitoring Service 42 Cryptogenic S

  43. Slide 43: How remote monitoring works: the CareLink system

    HOW REMOTE MONITORING WORKS THE MEDTRONIC CARELINK SYSTEM Schematic representation of the CareLink™ system for data transfer between ICM and healthcare professional. 43 Cryptogenic Stroke Therapy Awareness

  44. Slide 44: Reveal LINQ Mobile Manager

    REVEAL LINQ™ MOBILE MANAGER SIMPLE, FLEXIBLE, CONNECTED Reveal LINQ™ Mobile Manager is an innovative app-based programming solution for Reveal LINQ™ devices:  A flexible tablet-based system for both iOS and Android operating systems.  Communicates wirelessly via Bluetooth technology built into our

  45. Slide 45: FOCUSON superior monitoring and triage service

    FOCUSON™ SUPERIOR MONITORING AND TRIAGE SERVICE A service that saves time for healthcare professionals and enables a higher quality of care. THE CONTINUOUS FOCUSON™ PROCESS The FOCUSON™ service is built around a highly skilled team that classifies transmitted patient data based on agreed protocol an

  46. Slide 46: Cryptogenic Stroke Care Pathway

    CRYPTOGENIC STROKE CARE PATHWAY

  47. Slide 47: Ischemic stroke work-up

    ISCHEMIC STROKE STROKE WORK-UP Lacunar infraction: 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 Antiplatelet agent Standard stroke work-

  48. Slide 48: 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

  49. Slide 49: Conclusions

    CONCLUSIONS  Approximately one-third of ischemic strokes are classified as cryptogenic  Up to 30% of cryptogenic stroke patients have 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 cryp

  50. Slide 50: Patient Case Study

    PATIENT CASE STUDY Medtronic Further, Together

  51. Slide 51: 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

  52. Slide 52: Case study

    CASE STUDY  51-year-old woman  Episode of unsteady gait and dizziness (< 1 hour)  On admission:  BP 140/86 20%  HR 68 BPM  No neurologic deficits  After urgent MRI, admitted to intensive care unit for further assessment 52 Cryptogenic Stroke Therapy Awareness

  53. Slide 53: 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

  54. Slide 54: 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 54 Cryptogenic Stroke Therapy Awareness

  55. Slide 55: 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 55 Cryptogenic Stroke

  56. Slide 56: Case study

    CASE STUDY 56 Cryptogenic Stroke Therapy Awareness

  57. Slide 57: 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

  58. Slide 58: Brief statement

    BRIEF STATEMENT See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan device, see the MRI SureScan® technical manual before performing an

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