Medtronic Plc. · NYSE:MDT
Medtronic — Technical Presentation (March 2017)
40 slides from Medtronic's technical presentation, March 2017
Slide 1: Syncope Therapy Awareness Presentation
SYNCOPE THERAPY AWARENESS PRESENTATION
Slide 2: The Syncope Challenge
THE SYNCOPE CHALLENGE Syncope accounts for 740,000 ER visits per year, accounting for Magnitude 237,000 hospitalizations*1 Inpatient Approximately half of patients admitted to hospital leave without Challenge a diagnosis.2 Patient’s In reaching a diagnosis patients see 3 different specialists, under
Slide 3: Unexplained Syncope + Cardiac Syncope Over 50% of Patients
UNEXPLAINED SYNCOPE + CARDIAC SYNCOPE OVER 50% OF PATIENTS Syncope remains Neurally unexplained in Mediated approximately vasovagal, carotid sinus, situational 1/3 of cases 24% Unknown 34% Cardiac abnormal rhythms, structural damage 18% Orthostatic/ Neurologic Drug-induced Seizure, stroke, TIA etc A
Slide 4: Syncope: The Cause Matters
SYNCOPE THE CAUSE MATTERS Cardiac syncope: Overall Survival of Participants with Carries a 6-month mortality Syncope According to Cause rate of greater than 10% Doubles the risk of death Source: Soteriades ES, et al. N Engl J Med. 2002;347:878-885. 4 4 Syncope | Therapy Awareness Presentation |
Slide 5: 2017 ACC/AHA/HRS Guideline for Evaluation and Management of Syncope
2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society Developed in Collaboration With the American College of Emergency P
Slide 6: Evidence Level Definitions – New Descriptors
EVIDENCE LEVEL DEFINITIONS – NEW DESCRIPTORS Note: types of clinical data qualify level of evidence •i.e. “randomized”/ ”non randomized” Source: Shen WK, et al.. J Am Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03.003. 6 Syncope | Therapy Awareness Presentation | March 2017
Slide 7: Syncope Initial Evaluation
SYNCOPE INITIAL EVALUATION Source: Shen WK, et al.. J Am Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03.003. 7 Syncope | Therapy Awareness Presentation | March 2017
Slide 8: Characteristics Identifying Patients Most Likely Associated With a Cardiac Cause
CHARACTERISTICS IDENTIYING PATIENTS MOST LIKELY TO BE ASSOCIATED WITH A CARDIAC CAUSE Class LOE Recommendation Evaluation of the cause and assessment for the short- and long-term I B-NR morbidity and mortality risk of Syncope are recommended Historical Characteristics Associated with Increased Proba
Slide 9: Characterizing Risk Score of Syncopal Patients
CHARACTERIZING RISK SCORE OF SYNCOPAL PATIENTS Class LOE Recommendation Evaluation of the cause and assessment for the short- and long-term I B-NR morbidity and mortality risk of syncope are recommended Short-term (<30 d) risk factors Long-term (>30d) risk factors Older age (>60yr) Older age (>6
Slide 10: Syncope Evaluation Care Pathway
SYNCOPE EVALUATION CARE PATHWAY After initial evaluation and if cardiac cause is suspected, cardiac monitoring should be performed – Class I Recommendation ICMs should be placed in all patients with infrequent symptoms Source: Shen WK, et al.. J Am Coll Cardiol. 2017. DOI: 10.1016/j.jacc.2017.03
Slide 11: Cardiac Monitoring Recommendations
CARDIAC MONITORING RECOMMENDATIONS Class LOE Recommendation The choice of a specific cardiac monitor should be determined on the I C-EO basis of the frequency and nature of syncope events. To evaluate selected ambulatory patients with syncope of suspected IIa B-R arrhythmic etiology, an ICM can be u
Slide 12: Monitoring Selection Criteria: The Right Device for the Right Patient
MONITORING SELECTION CRITERIA THE RIGHT DEVICE FOR THE RIGHT PATIENT Holter Extended External Loop Mobile Cardiac Insertable Monitors Holters Recorders Telemetry Cardiac Monitors Duration 24 – 48 hrs 2-14 days Up to 1 month ≤3 years Patient Daily Weekly Monthly Monthly Recurrent, Selection symptoms
Slide 13: ESC Syncope Guidelines: Recommendations for Use of ICM Monitoring
ESC SYNCOPE GUIDELINES RECOMMENDATIONS FOR THE USE OF ICM MONITORING Class I Indicated in early phase of evaluation in patients with recurrent ICM syncope of uncertain origin, absence of high risk criteria, and a high Guidelines likelihood of recurrence within battery longevity of the device Ind
Slide 14: NICE Clinical Syncope Guideline: Diagnostic Testing by Frequency of Symptoms
NICE CLINICAL SYNCOPE GUIDELINE DIAGNOSTIC TESTING ACCORDING TO FREQUENCY OF SYMPTOMS Frequency of Syncope Suggested ECG Monitoring Technique Several times a week 24-48h Holter monitoring Every 1-2 weeks External loop recorder Less than once per month Implantable loop recorder Source: NICE Clinical
Slide 15: Syncope Guidelines: Are They Followed?
SYNCOPE GUIDELINES: ARE THEY FOLLOWED? SIGNIFICANT PROPORTION OF HCPs STATE THEY WOULD USE MONITORING INCONSISTENT WITH GUIDELINES Type of monitor recommended based on the frequency of syncope episodes Event ICM Holter 100% 13% 11% 12% 14% 3% 9% 13% 35% 9% 20% 53% 62% ICM / ILR 63% 65% 44% MCOT % of
Slide 16: Reveal LINQ System Advantages: ICMs Are Underutilized
REVEAL LINQ SYSTEM ADVANTAGES POWERFUL CARDIAC MONITORING ICMs are underutilized ICMs are recommended by clinical guidelines1,2 ─ yet significantly underutilized Up to 3 in 4 Patients who met appropriate criteria for ICM implantation did not receive one3 1 Moya A, et al. Eur Heart J. 2009;30:2631-26
Slide 17: Patients & Healthcare Providers Struggle to Find the Answer
PATIENTS & HEALTHCARE PROVIDERS STRUGGLE TO FIND THE ANSWER Patients endure ongoing diagnostic testing and still come away with no answers 3 13 1 in 4 specialists Inconclusive Undergo visited tests more than on average 20 tests Source: Edvardsson N, et al. Europace. 2011;13:262-269. 17 Syncope | The
Slide 18: Patient Experience
PATIENT EXPERIENCE 70% of patients had been hospitalized at least once for syncope. 36% of patients had experienced significant trauma in association with a syncopal episode. Overall, patients had seen an average of 3 different specialists for their syncope. Source: Edvardsson N, et al. Europa
Slide 19: PICTURE Study: Diagnostic Tests Performed Before Reveal ICM
DIAGNOSTIC TESTS PERFORMED BEFORE REVEAL™ ICM PICTURE STUDY Total recruitment 570 (100%) The median number of tests Standard ECG 556 (98%) performed per patient was 13 Echocardiography 490 (86%) (inter-quartile range 9 - 20) Basic laboratory tests 488 (86%) Ambulatory ECG monitoring 382 (67%) In-hos
Slide 20: Syncope Diagnosis Testing Options & Yield
SYNCOPE DIAGNOSIS TESTING OPTIONS & YIELD Test / Procedure Yield* ECG 2-11%1 Holter Monitoring 2%2 External Loop Recorder 20%3 Tilt Table 11%+4,5 EP Study without structural heart disease 11%6 Neurological (CT scan, carotid doppler) 0-4%5 Reveal ICM 78%7 *Based on mean diagnosis time of 5.1 mos.2 1
Slide 21: PICTURE Study: ICM Success in Diagnosing Patients With Syncope
ICM SUCCESS IN DIAGNOSING PATIENTS WITH SYNCOPE PICTURE STUDY 570 Patients Study Design Investigated the effectiveness of Reveal™ ICM in the diagnosis of unexplained recurrent syncope in everyday clinical practice Helped inform current guidelines Conclusion A Reveal ICM should be implanted rathe
Slide 22: Syncope Algorithm
SYNCOPE ALGORITHM SHD = Structural Heart Disease CSM = Carotid Sinus Massage EPS = Electrophysiologic Study *Provides up to 36 months of continuous monitoring. This is a general protocol to assist with the management of patients. This is not designed to replace clinical judgment or individual patien
Slide 23: ICMs Are a Cost-Effective Diagnostic Tool
ICMs ARE A COST-EFFECTIVE DIAGNOSTIC TOOL REDUCE COST WITH EARLIER UTILIZATION Multiple studies show ICM monitoring resulted in cost savings in syncope patients compared to conventional testing through fewer tests and hospital admissions.1-4 6 1 Krahn AD, J Am Coll Cardiol.August 6, 2003;42(3):495-5
Slide 24: Economic Value: Reveal LINQ ICM and the Care Continuum
ECONOMIC VALUE REVEAL LINQ ICM AND THE CARE CONTINUUM Long-term benefits of Reveal LINQ™ ICM Accurate diagnosis and defined care continuum PATIENT CARE CONTINUUM NO ICM IMPLANTED ICM IMPLANTED ✕ Care continuum is variable or unknown Accurate diagnosis of cardiac ✕ Further diagnostic testing, with
Slide 25: Experience the Reveal LINQ Advantage
EXPERIENCE THE REVEAL LINQ™ ADVANTAGE REVEAL LINQ™ INSERTABLE CARDIAC MONITOR AN OVERVIEW
Slide 26: Reveal LINQ System Advantages: 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 27: 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 NEW App-based Reveal NEW Monitoring LINQ Mobile Manager Service Solutions 27 Syncope | Therapy
Slide 28: 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
Slide 29: 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. 29 Syncope | Therap
Slide 30: 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.1-5 Real-world impact.1,6,7 CLINICAL RIGOR Proven arrhythmia detection.1,8,9 Informed clinical decisions.
Slide 31: Clinical Rigor: Evidence Superiority, Real-World Impact
CLINICAL RIGOR EVIDENCE SUPERIORITY. REAL-WORLD IMPACT. Most With Withananevidence portfolio evidence of 500+ portfolio published of 500+ clinical published articlesarticles clinical and Studied 1 ICM abstracts and abstracts 1 Most Clinically AcrossCryptogenic Across Cryptogenic Stroke, Stroke, Sync
Slide 32: 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
Slide 33: TruRhythm Intelligent Detection: New Algorithms
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 Syncope |
Slide 34: Advanced Monitoring: 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 35: Economic Value: Syncope
ECONOMIC VALUE SYNCOPE Clinical impact of Reveal™ ICM in syncope patients Accurately Diagnose Effectively Treat 13 78% 75% 25% Median number of Patients that receive a of Reveal-guided Reveal ICM patients inconclusive tests diagnosis following a diagnoses were found that receive device before ICM wa
Slide 36: 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
Slide 37: 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. S
Slide 38: 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
Slide 39: 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
Slide 40: Indications, Safety, and Warnings
INDICATIONS, SAFETY, AND WARNINGS 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, but are