Medtronic Plc. · NYSE:MDT
Medtronic — Investor Presentation
30 slides from Medtronic's investor presentation
Slide 1: Syncope Therapy Awareness Presentation
SYNCOPE THERAPY AWARENESS PRESENTATION Reveal LINQ™ Insertable Cardiac Monitoring System
Slide 2: Agenda
• Epidemiology • Diagnosis • Guidelines and Evidence to Support Reveal LINQ™ ICM in Syncope Patients • Syncope Care Pathway
Slide 3: Syncope Overview
SYNCOPE OVERVIEW Medtronic Further, Together
Slide 4: Syncope Definition
SYNCOPE DEFINITION A loss of consciousness with complete recover, usually TLoC Definition1 spontaneous in onset TLoC Non - traumatic Traumatic (concussion) Syncope Epileptic seizure Substance abuse Psychogenic • Neurological disorder • Alcohol or drug • Often an involuntary • Temporary loss of in wh
Slide 5: Unexplained Syncope + Cardiac Syncope
UNEXPLAINED SYNCOPE + CARDIAC SYNCOPE OVER 50% OF PATIENTS Syncope remains unexplained in Neurally approximately Mediated 1/3 of cases1 vasovagal, carotid sinus, situational 24% Unknown 34% Cardiac abnormal rhythms, structural damage 18% Orthostatic/ Neurologic Drug-induced Seizure, stroke, TIA etc.
Slide 6: The Syncope Challenge
THE SYNCOPE CHALLENGE Magnitude 40% of the population will have at least one syncope event.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, undergo Frustration 13 tests, and 1
Slide 7: The Cause Matters
SYNCOPE THE CAUSE MATTERS Cardiac syncope1: Overall Survival of Participants with Carries a 6-month mortality Syncope According to Cause rate of greater than 10% Doubles the risk of death 1. Soteriades ES, et al. N Engl J Med. 2002;347:878-885. 7 7 Syncope | Therapy Awareness Presentation | Dece
Slide 8: A Growing Challenge for the System
SYNCOPE A GROWING CHALLENGE FOR THE SYSTEM Prevalence of Syncope based on Age and Sex of Patients 50% of patients admitted to hospital for syncope-related events are >75 years of age1 10% of falls by elderly are attributed to syncope1 With an aging population, the prevalence of syncope is like
Slide 9: Diagnosing Syncope
DIAGNOSING SYNCOPE Medtronic Further, Together
Slide 10: Testing Options and Their Diagnostic Yields
SYNCOPE DIAGNOSIS TESTING OPTIONS AND THEIR DIAGNOSTIC YIELDS 1. Kapoor WN. Diagnostic evaluation of syncope. Am J Med. 1991;90:91-106. 2. Krahn et al. Recurrent syncope. Experience with an implantable loop recorder. Cardiol Clin. 1997;15:313-326. 3. Krahn et al. Cost implications of testing strateg
Slide 11: PICTURE Study: Overview
PICTURE STUDY1: OVERVIEW PICTURE was a prospective, multi-center, observational study conducted from November 2006 to October 2009 PICTURE aimed to: Collect information on the use of the Reveal™ ICM in the syncope patient care pathway Investigate Reveal ICM’s effectiveness in the diagnosis o
Slide 12: PICTURE Study Results: Patient Experience
PICTURE STUDY RESULTS PATIENT EXPERIENCE1 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 1. Edvardsson N
Slide 13: PICTURE Study Results: Diagnostic Tests Performed
PICTURE STUDY RESULTS DIAGNOSTIC TESTS PERFORMED1 The median number of tests performed per patient was 13 (inter-quartile range 9 - 20) 1. Edvardsson N, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry Europace 2011
Slide 14: PICTURE Study Results: Recurrence and Diagnostic Yield
PICTURE STUDY RESULTS SYNCOPE RECURRENCE AND DIAGNOSTIC YIELD1 During follow-up, 38% of patients had a recurrence of syncope within 1 year Reveal™ ICMs guided diagnosis in 78% of patients with recurrence 1. Edvardsson N, et al. Use of an implantable loop recorder to increase the diagnostic yield
Slide 15: PICTURE Study Results: Treatment Decisions
PICTURE STUDY RESULTS TREATMENT DECISIONS MADE IN RELATION TO SYNCOPE DIAGNOSIS1 Of the 170 Reveal ICM-guided diagnoses, 75% were cardiac-related 1. Edvardsson N, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry Eur
Slide 16: 6.5X More Patients Diagnosed
SUPERIOR DIAGNOSTIC YIELD THAN CONVENTIONAL TESTS 6.5X MORE PATIENTS DIAGNOSED1 6.5 x more ICM patients diagnosed Patients with unexplained syncope and without a pacing indication following basic clinical work-up, tilt-test and 24-h Holter Randomized to Reveal (n=103) or conventional testing (n=
Slide 17: Prolonged Monitoring Is Needed
PROLONGED MONITORING IS NEEDED THE MORE YOU LOOK, THE MORE YOU FIND1 When a strategy of prolonging monitoring is chosen, monitoring should be maintained even for several years until a diagnosis is established.1 1 Furukawa T, Maggi R, Bertolone C, Fontana D, Brignole M. Additional diagnostic value of
Slide 18: ICMs Are a Cost-Effective Diagnostic Tool
ICMs ARE A COST-EFFECTIVE DIAGNOSTIC TOOL PICTURE: EDVARDSSON, EUROPACE 2011 AND 20151,2 ICMs are a cost-effective strategy for patients Average spending amount to €2,000 with infrequent episodes of unexplained (£1,613) for diagnostic tests per syncope patient, without establishing a diagnosis.
Slide 19: Recommendations
RECOMMENDATIONS Medtronic Further, Together
Slide 20: Syncope Diagnosis: Gold Standard
SYNCOPE DIAGNOSIS GOLD STANDARD “The gold standard for the diagnosis of syncope is when a correlation between the symptoms and a documented arrhythmia is recorded.”1 1. Moya, A. et al. Guidelines for the diagnosis and management of syncope (version 2009): The Task Force for the Diagnosis and Managem
Slide 21: ESC Guidelines on Syncope
ESC GUIDELINES ON SYNCOPE RECOMMENDATION FOR USE OF ICM Class I ICM Guidelines • Indicated in early phase of evaluation in patients with recurrent syncope of uncertain origin, absence of high risk criteria and a high likelihood of recurrence within battery longevity of the device. • Indicated in hig
Slide 22: ESC Guidelines on Cardiac Pacing and CRT
ESC GUIDELINES ON CARDIAC PACING AND CRT DIAGNOSTIC TESTING ACCORDING TO FREQUENCY OF SYMPTOMS1 1. Brignole et al. ESC Guidelines on cardiac pacing and cardiac resynchronisation therapy. Eur Heart Journal (2013) 34, 2281–2329 22 Syncope | Therapy Awareness Presentation | December 2017
Slide 23: Use of ICM in Syncope Pathway Remains Inefficient
USE OF ICM IN SYNCOPE PATHWAY REMAINS INEFFICIENT EHRA SURVEY, EUROPACE 20141 42 European centers evaluated use of There is poor adherence to guidelines regarding ICM in clinical practice use of ICM in unexplained syncope Less than 20% of patients with unexplained syncope received an ICM in acco
Slide 24: Reveal LINQ System
REVEAL LINQ™ SYSTEM AN ADVANCED MONITORING SYSTEM Reveal LINQ™ ICM Wireless MyCareLink™ Cellular CareLink™ Network Patient Monitor & Reports Solution Enablers Insertion Tools Patient Assistant NEW App-based Reveal NEW FocusOn™ LINQ Mobile Manager Monitoring Service 24 Syncope | Therapy Awareness Pre
Slide 25: Reveal LINQ System: Revolutionizing Cardiac Monitoring
REVEAL LINQ SYSTEM 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 procedure2 1 Refer
Slide 26: Simple Insertion Procedure
REVEAL LINQ™ SYSTEM 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. 26 Syncope | Therapy Awareness
Slide 27: Putting It Into Practice
PUTTING IT INTO PRACTICE COLLABORATIVE RECOMMENDATION Endorsed by: • European Society of Emergency Medicine European Federation of Internal Medicine • European Union Geriatric Medicine Society • European Neurological Society • European Federation of Autonomic Societies Structured Care Pathway To
Slide 28: Syncope Testing Pathway
SYNCOPE TESTING PATHWAY SHD = Structural Heart Disease CSM = Carotid Sinus Massage EPS = Electrophysiologic Study *Provides up to 36 months of continuous monitoring. No This is a general protocol to assist with the management of patients. This is not designed to replace clinical judgment or individu
Slide 29: Conclusions
CONCLUSIONS Syncope care pathway remains inefficient, despite guidelines. ICMs should be implanted earlier in evaluation as supported by guidelines.1-4 In unexplained syncope, ICMs provide superior diagnostic yield compared to conventional tests, increasing rate of guideline directed therapy.5
Slide 30: 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