Slide 1: Experience the Reveal LINQ Advantage
EXPERIENCE THE REVEAL LINQ™ ADVANTAGE REVEAL LINQ™ INSERTABLE CARDIAC MONITOR AN OVERVIEW
Slide 2: Reveal ICM Product Evolution
REVEAL™ ICM PRODUCT EVOLUTION OVER 20 YEARS OF DEVELOPMENT EXPERIENCE IN ICMS 1998: 2000: 2007: 2007: 2011: Reveal Reveal Plus Reveal DX Reveal XT Fullview Software World’s first World’s second 3-year battery 3-year battery Improved data implantable loop implantable loop Added to the A
Slide 3: Powerful Cardiac Monitoring: Indications for Use
REVEAL LINQ SYSTEM ADVANTAGES POWERFUL CARDIAC MONITORING Indications for use The Reveal LINQ Insertable Cardiac Monitor (ICM) is an implantable patient-activated and automatically- activated monitoring system that records subcutaneous ECG and is indicated in the following cases: • Patients with cli
Slide 4: ICMs Are Underutilized
REVEAL LINQ SYSTEM ADVANTAGES POWERFUL CARDIAC MONITORING ICMs are underutilized ICMs are recommended by clinical guidelines2,3 ─ yet significantly underutilized Up to 3 in 4 Patients who met appropriate criteria for ICM implantation did not receive one4 4 Reveal LINQ™ Insertable Cardiac Monitoring
Slide 5: An Advanced Monitoring Solution
REVEAL LINQ SYSTEM ADVANTAGES AN ADVANCED MONITORING SOLUTION Reveal LINQ ICM Wireless MyCareLink™ Patient Cellular CareLink Network Monitor & Reports Solution Enablers Insertion Tools Patient Assistant NEW app-based Reveal LINQ™ FOCUSON™ Data Monitoring Mobile Manager & Triaging Service 5 Reveal LI
Slide 6: 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 monitoring5 MR Conditional at 1.5 and 3.0 Tesla Minimally invasive, simplified insertion procedu
Slide 7: 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.6 7 Reveal LINQ™ Insertable Cardiac Monitoring System
Slide 8: Smart ECG Data Storage
REVEAL LINQ SYSTEM ADVANTAGES 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
Slide 9: Smart ECG Data Storage
REVEAL LINQ SYSTEM ADVANTAGES SMART ECG DATA STORAGE ECG data storage: 59 minutes total Automatically detected: 27 minutes End of episode Pause, Brady, Tachy 30 sec 27 sec Start of episode AT/AF Automatic detection 2 minutes of longest AF episode stored since last interrogation in addition to the 27
Slide 10: Transforming Cardiac Monitoring
REVEAL LINQ SYSTEM ADVANTAGES TRANSFORMING CARDIAC MONITORING Transforming your ability to diagnose and treat even the most difficult-to-detect arrhythmias PROVEN ACCURACY Evidence superiority.1,8-11 Real-world impact. 8,12,13 CLINICAL RIGOR Proven arrhythmia detection. 8,14,15 Informed clinical dec
Slide 11: Proven Arrhythmia Detection. Informed Clinical Decisions.
REVEAL LINQ SYSTEM ADVANTAGES PROVEN ARRYTHMIA DETECTION. INFORMED CLINICAL DECISIONS. 99.4% Reveal LINQ is proven to find AF Highest published AF detection accuracy on the market, at 99.4%, streamlines data review8 63% 63% fewer false positives than shown in other ICM published data14 50+ As the mo
Slide 12: Duration-Based Performance Metrics
PROVEN ACCURACY DURATION-BASED PERFORMANCE METRICS Reveal LINQ AF monitoring 98.4% 99.5% Duration-based performance metrics8 SENSITIVITY SPECIFICITY 97.2% 99.7% PPV NPV 99.4% ACCURACY Comparison of AF burden detected by ICM and Holter 12 Reveal LINQ™ Insertable Cardiac Monitoring System
Slide 13: Patient and Episode-Based Performance Metrics
PROVEN ACCURACY PATIENT AND EPISODE-BASED PERFORMANCE METRICS Reveal LINQ AF monitoring Patient- and episode-based performance metrics8 Patient-based Episode-based 97.4% 97.0% 97.1% Sensitivity Specificity Specificity 92.5% 99.0% 90.4% PPV NPV PPV 99.4% Accuracy 13 Reveal LINQ™ Insertable Cardiac Mo
Slide 14: AF False Positive Comparison
PROVEN ACCURACY AF FALSE POSITIVE COMPARISON 50% Confirm-AF16 63% fewer false positives 40.9% with Reveal LINQ than shown in other False Positive Rate* ICM published data14 BioMonitor 2-AF17 25% 26.3% Reveal LINQ8 9.6% 0% *% of False Positives = (1 –Episode PPV). Episode PPV may vary (gross, patient
Slide 15: AT/AF Summary Report
PROVEN ACCURACY AT/AF SUMMARY REPORT Provides an overview of all atrial arrhythmias detected, including: % of time in AT/AF Average time in AT/AF per day Number of episodes at a given duration All patient and clinical data are fictitious and for demonstration purposes only. 15 Reveal LINQ™ Ins
Slide 16: Reveal LINQ ICM Cardiac Compass Report
PROVEN ACCURACY REVEAL LINQ ICM CARDIAC COMPASS™ REPORT Daily AF Burden Ventricular Rate During AF Day/Night HR Patient Activity Heart Rate Variability All patient and clinical data are fictitious and for demonstration purposes only. 16 Reveal LINQ™ Insertable Cardiac Monitoring System
Slide 17: Evidence Superiority. Real-World Impact.
CLINICAL RIGOR EVIDENCE SUPERIORITY. REAL-WORLD IMPACT. Most Studied ICM With an evidence portfolio of 500+ published clinical articles and abstracts1 Most Clinically Across Cryptogenic Stroke, Syncope, and Atrial Fibrillation Validated ICM patient populations8-10 Only ICM with Premier Publish
Slide 18: Cryptogenic Stroke
CLINICAL RIGOR CRYPTOGENIC STROKE Diagnosis of AF in stroke patient changes treatment protocol AF Affects 1-2% of the population.18 AF increases the risk of stroke 5×.19 Treatment with Oral Anti-coagulation (OAC)Therapy reduces the likelihood of experiencing stroke by 67.20 Stroke is the pre
Slide 19: Cryptogenic Stroke: Clinical Impact of Reveal ICM
CLINICAL RIGOR CRYPTOGENIC STROKE Clinical impact of Reveal ICM in stroke Detection of AF allows for treatment with OAC therapy Landmark Crystal-AF Study, published in the NEJM9 7× More patients with AF detected at 12 months with Reveal ICM9 84 Median number 7X of days to AF detection over 12 months
Slide 20: Cryptogenic Stroke: Real-World Practice
CLINICAL RIGOR CRYPTOGENIC STROKE Real-world practice with Reveal LINQ ICM Superiority of Reveal LINQ system to detect AF 12 in Cryptogenic Stroke patients Real-world practice validates superiority AF of the Reveal LINQ System to detect AF in cryptogenic stroke (CS) patients12,13 Everyday use of Rev
Slide 21: Syncope
CLINICAL RIGOR SYNCOPE 40% of the population will experience syncope22 Cardiac syncope doubles the risk of death MORTALITY MAGNITUDE UNDIAGNOSED FRUSTRATION Cardiac condition 3-5% of all ER 50% of all patients 13 different tests doubles the risk of visits24 leave the hospital during diagnosis de
Slide 22: Limited Yield of Many Diagnostic Tests
CLINICAL RIGOR SYNCOPE Limited yield of many diagnostic tests Diagnostic yield of non implantable diagnostic tests is less than 50% 100% 80% 78% Diagnostic Yield* 60% 49% 40% 20% 20% 11% 11% 2% 4% 0% ECG 26 Holter Monitor 27 External Loop EP Study w/o EP Study With Neurological (CT, Reveal ICM10 11
Slide 23: Syncope Guidelines
CLINICAL RIGOR SYNCOPE SYNCOPE GUIDELINES, European Heart Journal 20092 Recommendations for the use of ICM monitoring Guidelines for the diagnosis and management of syncope (version 2009) The Task Force for the Diagnosis and Management of Syncope of the European Society of Cardiology (ESC) Developed
Slide 24: Atrial Fibrillation: Suspected AF Monitoring
CLINICAL RIGOR ATRIAL FIBRILLATION SUSPECTED AF MONITORING Continuous monitoring can reveal AF Symptoms are not a good indicator for presence of AF31-35 Continuous monitoring with ICMs can identify AF in patients at high risk36,37 Study Method of Monitoring % Asymptomatic AF 22% of a patient pop
Slide 25: AF Management
CLINICAL RIGOR ATRIAL FIBRILLATION AF MANAGEMENT Optimize decisions pre- and post-ablation Document Baseline AF burden. Provide objective data for follow-up comparisons. Data to optimize pre/post management + re-ablation REVEAL ICM Case Planning Reliably identifies AF and confirms PRE PVI
Slide 26: Innovative Solutions. Simplified Experience.
ADVANCED MONITORING INNOVATIVE SOLUTIONS. SIMPLIFIED EXPERIENCE. STREAMLINED INSERTION ACTIONABLE REPORTS SIMPLIFIED PATIENT WORK FLOW MANAGEMENT Supported by an enhanced Medtronic Resources to support clinic CareLink Network efficiency and data review Industry’s highest diagnostic yields, with
Slide 27: New Reveal LINQ Mobile Manager
ADVANCED MONITORING NEW REVEAL LINQ MOBILE MANAGER Simplify device management with IT’S EASY TO GET STARTED the NEW Reveal LINQ Mobile Manager, an innovative app-based programming system SUPPORTED TABLET MEDTRONIC Visit LINQMobileManager.com PATIENT for the most up-to-date list of CONNECTOR supporte
Slide 28: Clinically Actionable Reports
ADVANCED MONITORING CLINICALLY ACTIONABLE REPORTS Easy-to-use, clinically actionable reports4 The information you need when you need it, supported by an enhanced CareLink Network 95% of physicians found Comprehensive the Reveal LINQ reports easy to use Get the full picture with and clinically diag
Slide 29: Clinically Actionable Reports
ADVANCED MONITORING CLINICALLY ACTIONABLE REPORTS Easy-to-use, clinically actionable reports6 The information you need when you need it Event Report Summary Report Full Report Data may help in timely Data may help in routine Manual transmission management of patients. management of patients. from pa
Slide 30: New Clinician Learning Plan
ADVANCED MONITORING NEW CLINICIAN LEARNING PLAN New clinician learning plan on Medtronic Academy Supports streamlined Reveal LINQ patient management Tailored to meet your needs for easier data and patient management. Integrates best practices from 100+ clinicians nationwide. Master Use of Reports.
Slide 31: New FOCUSON Monitoring and Triaging Service
ADVANCED MONITORING NEW FOCUSONTM MONITORING AND TRIAGING SERVICE FOCUSONTM monitors and triages data, freeing up time for hospital Clinical Teams Remote monitoring of patients The CareLink™ Network receives data from patients with Reveal LINQ™ ICM and other implanted devices. Monitoring and Triagin
Slide 32: References
REFERENCES 1. Medtronic Reveal Publications. Medtronic data on file. 2016. 2. Task Force for the Diagnosis and Management of Syncope, European Society of Cardiology (ESC), European Heart Rhythm Association (EHRA), et al. Guidelines for the diagnosis and management of syncope (version 2009). Eur Hear
Slide 33: References
REFERENCES 26. Atkins D, Hanusa B, Sefcik T, et al. Syncope and orthostatic hypotension. Am J. Med. 1991;91,179-185. 27. Krahn, AD, Klein, GJ, Yee, R. Recurrent syncope: experience with an implantable loop recorder. Cardiol Clin. 1997;15:313–326. 28. Linzer, M., et al. Diagnosing Syncope. Ann Intern
Slide 34: Brief Statement
BRIEF STATEMENT Brief Statement See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Medtronic and the Medtronic logo are trademarks of Medtronic.™* Third party brands are trademarks of th