Medtronic Plc. · NYSE:MDT
Medtronic — Investor Presentation
44 slides from Medtronic's investor presentation
Slide 1: Cryptogenic Stroke Therapy Awareness Presentation
CRYPTOGENIC STROKE THERAPY AWARENESS PRESENTATION
Slide 2: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ ICM CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 2 Cryptogenic Stroke Therapy Awareness Program
Slide 3: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ ICM CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 3 Cryptogenic Stroke Therapy Awareness Program
Slide 4: Stroke as a Healthcare Issue
STROKE AS A HEALTHCARE ISSUE § Each year, approximately 800,000 Americans experience a new or recurrent stroke.1 § Ischemic stroke accounts for 87% of strokes overall, with the remaining 13% classified as hemorrhagic in origin.1 § Stroke is the 5th most common cause of death in the United States; hi
Slide 5: 678,000 Ischemic Strokes Every Year in the U.S.
678,000 ISCHEMIC STROKES EVERY YEAR IN THE U.S.1 LEADING CAUSE OF DISABILITY IN THE U.S. AND WORLDWIDE § Despite a comprehensive diagnostic workup, about 30% of stroke patients remain cryptogenic.1-6 20% 30% Cryptogenic § Most cryptogenic stroke patients receive antiplatelet for Stroke secondary pre
Slide 6: Cryptogenic Stroke Diagnosis
CRYPTOGENIC STROKE DIAGNOSIS Cryptogenic Stroke Cryptogenic stroke possible Cryptogenic stroke ESUS is a subgroup of etiologies1 includes cryptogenic stroke2 § Substenotic atherosclerosis § Incomplete evaluation § Non-lacunar ischemic stroke § Aortic arch disease § No cause found from detected by CT
Slide 7: Secondary Stroke Prevention: AF Detection and Treatment Matters
SECONDARY STROKE PREVENTION AF DETECTION AND TREATMENT MATTERS § There is a 5-fold increase in ischemic stroke risk for AF patients.1 § Ischemic stroke associated with AF is twice as likely to be fatal as non-AF stroke.2 § There is a 67% decrease in AF stroke risk with oral anticoagulants.3 § 1 in 4
Slide 8: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ ICM CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 8 Cryptogenic Stroke Therapy Awareness Program
Slide 9: Current Medical Paradigm
CURRENT MEDICAL PARADIGM Cryptogenic stroke Atrial fibrillation No atrial fibrillation Anticoagulation* or Antiplatelet until other management1-3 cause is identified1-3 *If the patient is an appropriate candidate. The detection of AF in this patient population changes the medical management for seco
Slide 10: ESUS Outcomes
ESUS OUTCOMES Number Trial Primary Study Sample of Required Duration Efficacy Outcome Messages Drugs Size Outcomes (months) Outcome NAVIGATE ESUS1 Rivaroxaban 15 OD 555 7,121 24 Stroke and systemic Increase in bleeding in the rivaroxaban arm In ESUS patients, dabigatran was not superior vs. Stopped
Slide 11: ESUS Outcomes
ESUS OUTCOMES NAVIGATE ESUS RE-SPECT ESUS Increase in bleeding in the rivaroxaban arm NEGATIVE1 Dabigatran was not superior to ASA FAILED PRIMARY OUTCOME2 There is no proven clinical benefit of giving oral anticoagulation therapy to all ESUS patients or in changing current practice for treatment of
Slide 12: Conventional Monitoring Strategies
CONVENTIONAL MONITORING STRATEGIES Bedside Monitoring Holter Monitor Event Recorder Mobile Cardiac Telemetry During stroke unit or 24 hours — 2 weeks intensive care unit stay Up to 30 days of monitoring Up to 30 days of monitoring of monitoring Event-triggered recording available External recorder E
Slide 13: ICM Definition
ICM DEFINITION § An insertable cardiac monitor (ICM) is a small device that is inserted subcutaneously in the left pre-pectoral region to continuously monitor a patient’s ECG and other physiological parameters.1 § The device records cardiac information in response to automatically detected arrhythmi
Slide 14: Continuous Monitoring Is Superior to Intermittent
CONTINUOUS MONITORING IS SUPERIOR TO INTERMITTENT CRYSTAL AF SUB-ANALYSIS: CHOE, AM J CARDIOL 20151 “Intermittent rhythm monitoring would have failed Sensitivity was low: 1.3-22.8% to identify previously undiagnosed AF in the vast Negative predictive value: 82.3-85.6% majority of CS patients.” Simul
Slide 15: Summary of ICM Studies in Cryptogenic Stroke
SUMMARY OF ICM STUDIES IN CRYPTOGENIC STROKE Duration of monitoring Study Definition of AF Time to Diagnosis (days) AF detection rate (%) (months) 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 Zi
Slide 16: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ ICM CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 16 Cryptogenic Stroke Therapy Awareness Program
Slide 17: CRYSTAL AF: Study Design and End Points
CRYSTAL AF — JUNE 2014 STUDY DESIGN AND END POINTS § Randomized, multicenter, controlled clinical trial with 441 patients § Compared continuous, long-term monitoring with Reveal™ XT ICM vs. conventional § Assessment at scheduled and unscheduled visits § ECG monitoring performed at the discretion of
Slide 18: CRYSTAL AF: Study Population
CRYSTAL AF: STUDY POPULATION 447 Patients were enrolled Excluded 6 § § 4 did not meet eligibility criteria 2 withdrew consent 441 Underwent randomization Assigned to ICM 221 § § 208 had ICM inserted 13 did not have ICM inserted 220 Assigned to control § 220 received standard of care 12 Crossed over
Slide 19: CRYSTAL AF: Rigorous Inclusion Criteria
CRYSTAL AF: RIGOROUS INCLUSION CRITERIA PATIENTS WERE ONLY CATEGORIZED WITH CRYPTOGENIC STROKE AFTER EXTENSIVE DIAGNOSTIC TESTING Age 40-55 years Age ≥ 55 years § Diagnosis of stroke or TIA occurring within previous 90 days § Stroke was classified as cryptogenic after extensive testing: § 12-lead EC
Slide 20: CRYSTAL AF: Baseline Patient Characteristics
CRYSTAL AF: BASELINE PATIENT CHARACTERISTICS Patent Index Index Age Male White Foramen Event Event (years) Ovale STROKE TIA ICM 61.6 64.3% 87.8% 23.5% 90.5% 9.5% N = 221 ± 11.4 CONTROL 61.4 62.7% 86.8% 20.9% 91.4% 8.6% N = 220 ± 11.3 P 0.84 0.77 0.60 0.57 0.87 ICM and control group have similar char
Slide 21: CRYSTAL AF: Monitoring with ICM Superior to SoC
CRYSTAL AF: MONITORING WITH ICM SUPERIOR TO SOC DETECTION OF AF Primary End Point § Time to first detection of AF at 6 months of follow-up § Continuous monitoring with Reveal™ ICM is superior to SoC for the detection of AF in cryptogenic stroke patients Secondary End Point § Time to first detection
Slide 22: Predictors of AF Offer Only Poor Predictive Ability
PREDICTORS OF AF OFFER ONLY POOR PREDICTIVE ABILITY CRYSTAL AF SUB-ANALYSIS: THIJS, NEUROLOGY 20161 Increasing age and a prolonged PR-interval were independently associated with AF, but the predictive ability of these parameters was only moderate. Type and Age, sex, Body mass severity of race index
Slide 23: Real-World Validation of CRYSTAL AF Results
REAL-WORLD VALIDATION OF CRYSTAL AF RESULTS § 1,247 real-world cryptogenic stroke patients monitored by Reveal LINQ™ ICM § Cryptogenic stroke diagnosis: physician’s discretion § Follow-up: 12 months § Diagnostic yield at 12 months: 16.3% (n = 147) § 72% of AF patients would be missed if monitoring s
Slide 24: DISCOVERYLINK: Cryptogenic Stroke at 2 Years
DISCOVERYLINK – CRYPTOGENIC STROKE AT 2 YEARS ZIEGLER, INT J CARDIOL. 20171 § De-identified Medtronic device database analysis at 2 years § Follow-up: 579 ± 222 days § AF ≥ 2 min was detected in 16.3% at 1 year and in 21.5% at 2 years (vs. 4.6% at 30 days) § Median time to detection: 112 days § In 7
Slide 25: EMBRACE & CRYSTAL AF: Different Studies, Different Results
EMBRACE & CRYSTAL AF: DIFFERENT STUDIES, DIFFERENT RESULTS EMBRACE1 CRYSTAL AF2 Higher AF detection rates Inclusion Criteria Inclusion Criteria than CRYSTAL AF … why? Study characteristics § 16 centers in Canada § Age ≥ 55 years § Age ≥ 40 years § Ischemic stroke or TIA § Ischemic stroke or TIA Stro
Slide 26: Why Extended Monitoring?
WHY EXTENDED MONITORING? SHORT- AND INTERMEDIATE-TERM MONITORING MAY MISS MANY PATIENTS WITH PAROXYSMAL AF 79% of first AF episodes were asymptomatic at 12 months1 88% of patients who had AF would have been missed if only monitored for 30 days*1 *Based on Kaplan-Meier estimates. 1 Sanna T, et al. N
Slide 27: Impact of Prolonged Cardiac Monitoring on Secondary Stroke Prevention
IMPACT OF PROLONGED CARDIAC MONITORING ON SECONDARY STROKE PREVENTION TSIVGOULIS, STROKE 20191 § Meta-analysis: 2 RCTs and 2 observational studies reporting stroke recurrence in patients with cryptogenic stroke/TIA § N = 1,102 monitored by ICM or 10-day ambulatory ECG § Follow-up: 8-30 months § Prol
Slide 28: Impact of Prolonged Cardiac Monitoring: Meta-Analysis Details
Flow chart presenting the selection of eligible studies (IS: ischemic stroke, IMPACT OF PROLONGED CARDIAC MONITORING TIA: transient ischemic attack, PCM: prolonged cardiac monitoring)5 ON SECONDARY STROKE PREVENTION Records identified Records identified Identification through MEDLINE & through medic
Slide 29: AF Incidence in the First Month After Cryptogenic Stroke
AF INCIDENCE IN THE FIRST MONTH AFTER A CRYPTOGENIC STROKE IS DETECTED WITH AN ICM AHA POSTER: MILSTEIN, CIRCULATION 20181 Design and Objectives Results § To determine the incidence of ICM detected AF in the first 20 days § N = 343 (55% male) following a cryptogenic stroke § Patient characteristics:
Slide 30: 2019 AHA/ACC/HRS AF Guidelines Recommend ILR
2019 AHA/ACC/HRS ATRIAL FIBRILLATION GUIDELINES RECOMMEND USE OF ILR FOR CRYPTOGENIC STROKE Source: January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Ca
Slide 31: Superior Evidence: 2016 ESC AF Guidelines
SUPERIOR EVIDENCE: ICM RECOMMENDATION FOR CRYPTOGENIC STROKE 2016 ESC* AF GUIDELINES DEFINITION Weight of evidence/ opinion is in favor of usefulness/efficacy RECOMMENDATION CLASS IIa SUGGESTED WORDING TO USE Should be considered LEVEL OF In stroke patients, additional ECG EVIDENCE monitoring by lon
Slide 32: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ ICM CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 32 Cryptogenic Stroke Therapy Awareness Program
Slide 33: The Reveal LINQ Advantage: An Advanced Monitoring Solution
THE REVEAL LINQ™ ADVANTAGE AN ADVANCED MONITORING SOLUTION Reveal LINQ™ ICM MyCareLink™ Patient Monitor CareLink™ Network and Reports SOLUTION Insertion Tools Patient Assistant ENABLERS Minimally invasive One-button procedure symptom marking 33 Cryptogenic Stroke Therapy Awareness Program
Slide 34: The Reveal LINQ Advantage: Simple Insertion Procedure
THE REVEAL LINQ™ ADVANTAGE 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 intuitive1 Requires minimal procedure time and clinical resources 1 Reveal LINQ Usability Study.
Slide 35: The Reveal LINQ ICM Advantage: Superior Evidence
THE REVEAL LINQ™ ICM ADVANTAGE SUPERIOR EVIDENCE MOST MOST MOST STUDIED VALIDATED UTILIZED Evidence portfolio that Clinical validation across Data leveraged by clinical includes 700+ published cryptogenic stroke, societies to develop clinical articles and abstracts syncope, and atrial treatment guid
Slide 36: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 36 Cryptogenic Stroke Therapy Awareness Program
Slide 37: Conclusions
CONCLUSIONS Stroke facts § 30% of ischemic strokes are cryptogenic (unexplained).1-6 § Cryptogenic stroke patients have the highest mortality risk among all stroke types.7 § 1 in 4 survivors will experience another stroke within five years.8 § 5-fold increase risk for stroke in patients with atrial
Slide 38: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ ICM CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 38 Cryptogenic Stroke Therapy Awareness Program
Slide 39: Why Do You Need a Cryptogenic Stroke Pathway?
WHY DO YOU NEED A CRYPTOGENIC STROKE PATHWAY? BETTER MULTIDISCIPLINARY STROKE CARE For your patients § Better risk reduction strategy to prevent a secondary stroke § Ensures quality post-stroke care § Care focused on patient needs: Find an answer For your hospitals § Better risk reduction strategy t
Slide 40: Multidisciplinary Care Pathway: Key Stakeholders
MULTIDISCIPLINARY CARE PATHWAY FOR CRYPTOGENIC STROKE WHO ARE THE KEY STAKEHOLDERS? 40 Cryptogenic Stroke Therapy Awareness Program
Slide 41: 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
Slide 42: Contents
CONTENTS STROKE FACTS CURRENT PRACTICE FOR MONITORING & TREATMENT EVIDENCE REVEAL LINQ™ ICM CONCLUSIONS PATHWAY DEVELOPMENT CASE STUDY 42 Cryptogenic Stroke Therapy Awareness Program
Slide 43: Cryptogenic Stroke Patient Impact: Scott's Story
THE REVEAL LINQ™ ADVANTAGE 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
Slide 44: Brief Statement
BRIEF STATEMENT Reveal LINQ™ LNQ11 Insertable Cardiac Monitor and Patient Assistant The Medtronic MyCareLink Patient Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient Indications data from Medtronic implantable cardiac devices. These products are not a subst