Medtronic Plc. · NYSE:MDT

Medtronic — Technical Presentation (January 2022)

32 slides from Medtronic's technical presentation, January 2022

  1. Slide 1: Syncope Therapy Awareness Presentation

    SYNCOPE THERAPY AWARENESS PRESENTATION

  2. Slide 2: The Syncope Challenge

    THE SYNCOPE CHALLENGE IMPACT 35% Syncope accounts for of the population 1-3% will have at least one syncopal event of emergency in their lifetime1 room visits2,3 32% HALF OF PATIENTS of those ER ADMITTED TO patients are THE HOSPITAL hospitalized4 AFTER A SYNCOPE EVENT LEAVE WITHOUT A DIAGNOSIS5 1 Ga

  3. Slide 3: Syncope Etiology: A Symptom with Many Possible Causes

    SYNCOPE ETIOLOGY A SYMPTOM WITH MANY POSSIBLE CAUSES Medication Cardiac 6.8% 9.5% Orthostatic Unexplained 9.4% 36.6% 26.5% of which will receive a cardiac Vasovagal diagnosis with 21.2% ICM monitoring* Other 7.5% Non-syncopal TLOC (Cough Syncope, Micturition 9.0% Syncope and Situational Syncope) (Se

  4. Slide 4: The Cause of Syncope Matters

    THE CAUSE OF SYNCOPE MATTERS CARDIAC CAUSE INCREASES >10% MORTALITY RATES mortality rate at six months Overall Survival of Participants with Syncope According to Cause 2X increased risk of death Source: Soteriades ES, et al. N Engl J Med. 2002;347:878-885. 4 Syncope Therapy Awareness | Reveal LINQ™

  5. Slide 5: Patients Need Answers

    PATIENTS NEED ANSWERS PICTURE STUDY 3 specialists visited on average Patients endure ongoing diagnostic testing and still come away with no answers Physician specialties consulted Diagnostic tests performed 13 inconclusive tests 1 in 4 undergo more than 20 tests Source: Edvardsson N, et al. Europace

  6. Slide 6: Syncope Diagnosis: Testing Options and Their Diagnostic Yield

    SYNCOPE DIAGNOSIS TESTING OPTIONS AND THEIR DIAGNOSTIC YIELD Test/Procedure Yield ECG 3-5%1 Holter Monitoring 5-11%2,3 External Loop Recorder 20%4 Tilt Table 15-21%1 EP Study without structural heart disease 10%5 Neurological (CT scan, MRI, carotid doppler) 1-2%1 Reveal™ ICM 43-59%2-4,6,7 1 Mendu ML

  7. Slide 7: Living Without a Diagnosis Compromises Quality of Life

    LIVING WITHOUT A DIAGNOSIS COMPROMISES QUALITY OF LIFE1-3 § 36% suffer significant trauma4 § 70% hospitalized at least once for syncope4 § 2x risk of loss of employment3 § 1.4x higher risk of on-the-job accidents3 Syncope compromises quality of life, affecting patients physically, economically, and

  8. Slide 8: Living Without a Diagnosis Is Costly to the Patient

    LIVING WITHOUT A DIAGNOSIS IS COSTLY TO THE PATIENT $26,000 per hospitalization*1 $12,988 $29,886 2 2 cost of minor injury† cost of major injury† $4,419 cost of conventional testing, which renders 2,3 low diagnostic yield of 5-20% vs. 44% ICM yield * Median cost † Mean cost of injury alone, not incl

  9. Slide 9: ICM More Likely to Diagnose Infrequent Syncope Than Conventional Testing

    ICM MORE LIKELY TO DIAGNOSE INFREQUENT SYNCOPE THAN CONVENTIONAL TESTING META-ANALYSIS: BRIGNOLE, EUROPEAN HEART J 2018 § Supported 2018 ESC Syncope Guidelines improved recommendation for ICM and published in guidelines supplement § n = 657 patients § Meta-analysis of 5 randomized clinical trials (p

  10. Slide 10: High Diagnostic Yield in Unexplained Syncope

    HIGH DIAGNOSTIC YIELD IN UNEXPLAINED SYNCOPE META-ANALYSIS: SOLBIATI, INT J CARDIOL 2017 § 49 studies (published 1998-2015), n = 4,381 patients § 44% diagnostic yield at 1 year and 25% were diagnosed with an arrhythmia § Diagnosis = ICM recording during recurrent event OR automatic detection of sign

  11. Slide 11: ICMs Are a Cost-Effective Diagnostic Tool

    ICMs ARE A COST-EFFECTIVE DIAGNOSTIC TOOL EARLIER UTILIZATION REDUCES COST Multiple studies show ICM monitoring resulted in cost savings in syncope patients compared to conventional testing through fewer tests and hospital admissions. 1-4 88% At 3 years monitoring, of patients who are guideline-elig

  12. Slide 12: Reveal ICM Guides Treatment Decisions

    REVEAL™ ICM GUIDES TREATMENT DECISIONS PICTURE STUDY 82% of Reveal ICM guided diagnoses led to treatment, with 57% receiving pacemaker or ICD Note: Therapy percentages listed include patients who received more than one therapy. Source: Edvardsson N, et al. Europace. 2011;13:262-269. 12 Syncope Thera

  13. Slide 13: The Longer You Look the More You Find

    THE LONGER YOU LOOK THE MORE YOU FIND VALUE OF SUPERIOR DIAGNOSTIC YIELD ü Accurate diagnosis ü Timely and informed ü Reduced cost of cardiac arrhythmia treatment decisions ICM CAN RULE IN OR RULE OUT CARDIAC CAUSE OF SYNCOPE1,2 3.6x 44% 20% more likely to reach a diagnostic yield of ICM of syncope

  14. Slide 14: Summary

    SUMMARY ü Syncope is prevalent and difficult to diagnose ü Patients suffer compromised quality of life and high costs ü ICM is more likely to provide a diagnosis than standard of care for unexplained syncope ü ICM is more cost-effective than standard of care ü ICM leads to treatment decisions ü Diag

  15. Slide 15: Syncope Guidelines

    SYNCOPE GUIDELINES Medtronic Further, Together

  16. Slide 16: 2017 ACC/AHA/HRS Guidelines for the Management of Syncope

    2017 ACC/AHA/HRS GUIDELINES FOR THE MANAGEMENT OF SYNCOPE § If initial evaluation is unclear and a cardiac cause is suspected, cardiac monitoring should be performed — Class I Recommendation § Patient selection is based on frequency of symptoms, likelihood of arrhythmic cause, and patient characteri

  17. Slide 17: Syncope Evaluation Care Pathway

    SYNCOPE EVALUATION CARE PATHWAY LONG-TERM MONITORING RECOMMENDATION IN THE EVALUATION OF INFREQUENT SYNCOPE *Applies to patients after a normal initial evaluation without significant injury or cardiovascular morbidities; patients followed up by primary care physician as needed. †In selected patients

  18. Slide 18: Monitoring Selection Criteria

    MONITORING SELECTION CRITERIA THE RIGHT MONITOR FOR THE RIGHT PATIENT Diagnostic choice of cardiac monitor should be based on frequency and nature of symptoms ICM is recommended for patients with symptoms > 30 days apart If initial monitoring is non-diagnostic, continue monitoring with ICM. Get to t

  19. Slide 19: 2018 ESC Syncope Guidelines

    2018 ESC SYNCOPE GUIDELINES Extensive changes from 2009 based on new evidence: § Increased role of prolonged ECG monitoring with ICM § Revised recommendation from Class I to Class II for Holter monitors and tilt tests § Increased importance of risk stratification from ED and referral to syncope spec

  20. Slide 20: T-LOC Monitoring Recommendations

    T-LOC MONITORING RECOMMENDATIONS T-LOC suspected syncope Certain diagnosis/mechanism Uncertain Diagnosis Treat appropriately Syncope T-LOC Non-syncopal High risk* Low risk* Low risk* Low risk* arrhythmia arrhythmia likely and reflex likely and need and rare episodes Unconfirmed epilepsy None indicat

  21. Slide 21: Experience the Reveal LINQ Advantage

    EXPERIENCE THE REVEAL LINQ ™ ADVANTAGE REVEAL LINQ™ INSERTABLE CARDIAC MONITOR AN OVERVIEW

  22. Slide 22: Reveal LINQ System Advantages: Revolutionizing Cardiac Monitoring

    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

  23. Slide 23: 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. 23 Syncope Therapy

  24. Slide 24: Reveal LINQ System Advantages: An Advanced Monitoring Solution

    REVEAL LINQ™ SYSTEM ADVANTAGES AN ADVANCED MONITORING SOLUTION Reveal LINQ ICM Wireless MyCareLink™ Cellular CareLink™ Network Patient Monitor & Reports Solution Enablers Insertion Tools Patient Assistant App-based Reveal Reveal LINQ *The Reveal LINQ Monitoring Service is provided by Medtronic Monit

  25. Slide 25: Smart ECG Data Storage

    THE REVEAL LINQ™ ADVANTAGE SMART ECG DATA STORAGE ECG data storage: 59 minutes total Patient-activated: up to 30 minutes 4 episodes @ 7.5 minutes each 6.5 min prior 1 min Patient-activated 3 episodes @ 10 minutes each 9 min prior 1 min Patient-activated 2 episodes @ 15 minutes each 14 min prior 1 mi

  26. Slide 26: Advanced Monitoring: Innovative Solutions, Simplified Experience

    ADVANCED MONITORING INNOVATIVE SOLUTIONS. SIMPLIFIED EXPERIENCE. STREAMLINED ACTIONABLE REPORTS SIMPLIFIED PATIENT INSERTION MANAGEMENT WORKFLOW § Supported by an enhanced Resources to support clinic Medtronic CareLink™ network efficiency and data review § Industry’s highest diagnostic yields, with

  27. Slide 27: TM Syncope Therapy Awareness | Reveal LINQ™ Insertable Cardiac Monitoring System

    TM 1 Pürerfellner H, et al. Europace. Published online October 3, 2017. 2 Medtronic Reveal Publications. Medtronic data on file. 2016. 27 Syncope Therapy Awareness | Reveal LINQ™ Insertable Cardiac Monitoring System

  28. Slide 28: Advanced Monitoring Syncope Patient Impact: William's Story

    ADVANCED MONITORING SYNCOPE PATIENT IMPACT William’s story Reveal LINQ™ ICM used to discover non-sustained SVT event William remembered his fainting spells seemed to come out of nowhere. The first time it happened was just after he stood up to get a second cup of coffee. He was unconscious for 30 se

  29. Slide 29: Advanced Monitoring Syncope Patient Impact: Kymberli's Story

    ADVANCED MONITORING SYNCOPE PATIENT IMPACT Kymberli’s story Reveal LINQ™ ICM used to discover malignant vasovagal syncope On a February morning in 2015, Kymberli, the busy mother of four young children prepared for her triplets’ first birthday party. Suddenly, she felt queasy, confused, and clammy.

  30. Slide 30: Advanced Monitoring Syncope Patient Impact: Debbie's Story

    ADVANCED MONITORING SYNCOPE PATIENT IMPACT Debbie’s story Reveal™ ICM used to discover a rare form of AT After Debbie fainted the first time, she didn't think much about it. As a cardiac nurse, she knew there were many reasons people faint. But the fainting continued, and within a couple of months s

  31. Slide 31: Indications, Safety, and Warnings

    INDICATIONS, SAFETY, AND WARNINGS If you are located in the United States, please refer to the brief statement below to review applicable indications, safety, and warning information. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warn

  32. Slide 32: Indications, Safety, and Warnings, Cont'd.

    INDICATIONS, SAFETY, AND WARNINGS, CONT'D. Patient Assistant Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. Potential Complications Potential complications include

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