MRI ACCESS. Evera MRI SureScan ICD Systems

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1 ACCESS Evera SureScan ICD Systems

2 ACCESS. 36% of ICD patients are likely to have an ordered over 4 years 3 Introducing Evera, featuring SureScan Technology. ICD Patients are not receiving s 1.4% 36% CONTOURED. Greater patient comfort with 30% reduction in skin pressure. 1 LONG-LASTING. So patients can spend more time living, and less time receiving device replacements. SMART.* The most advanced shock reduction suite, so patients receive fewer inappropriate shocks. 2 Non-ICD Patient Cohort 4 N = 9,385 ICD Patient Cohort 3 N = 9,385 Data from 2012 were used to project utilization in the ICD patient cohort over 4 years; whereas the actual utilization rate over 4 years was measured in the non-icd cohort. The Evera SureScan ICD system is MR Conditional and, as such, is designed to allow patients to be safely scanned by an machine when used according to the specified conditions for use. A complete SureScan ICD system, including the Evera SureScan ICD and one or two SureScan ICD leads, is required for use in the environment. 2 * SmartShock 3

3 EXPANDING ACCESS 100% Stroke patients with an ICD are not getting optimal diagnostic imaging 80% Percent of Patients 44% of non-icd patients undergo an within 3 days of stroke or TIA diagnostic vs. 1% of patients with a traditional ICD.3 Together, we can now provide ICD patients optimal imaging,according to ACR.*5 72% 69% 44% 20% 1% Ultrasound 80% Percent of Patients 22% of non-icd patients undergo an within 30 days of back pain diagnosis vs. 0.7% of patients with a traditional ICD.3 100% Back Pain WITH EVERA PATIENTS HAVE ACCESS TO FULL BODY SCANNING6 60% 40% 20% 32% 22% 29% 27% 21% 0.7% 0% X-ray 100% Joint Pain (Knees, ankles, elbows, shoulders & wrists) 4 72% 40% Superior for soft tissue Uses ionizing radiation (multiple scans means added risk to patient as x-ray dose is cumulative) Uses magnetic energy and RF (no cumulative dose risk) 17% of non-icd patients undergo an within 30 days of joint pain diagnosis vs. 0.1% of patients with a traditional ICD.3 80% Percent of Patients Better for bony tissue Contrast, if used, is iodine based and may cause allergic reactions 75% 60% 0% ICD Patients Non-ICD Patients 60% 40% 30% 28% 20% Contrast (if used) has low risk 0% 16% 19% 17% 0.1% * American College of Radiology. X-ray 5

4 PROVEN EVIDENCE AND EXPERIENCE SureScan Technology backed by 5 prospective clinical trials and robust computer modeling Evera Clinical Study 12 Prospective, randomized study 275 patients at 42 centers globally No positioning restrictions Demonstrated that the system is safe and effective DEVELOP SureScan Pacing Lead and Industry Exclusive Modeling Capability TEST SureScan Lead with 400,000 Modeling Scenarios EnRhythm Clinical Trial SureScan Patients SureScan Post-Approval Clinical Study 8 Advisa Clinical Trial SureScan Patients REFINE Improve Modeling with Accuracy and Speed TEST 5076 Lead, 6935M Lead, 6947M Lead with 2.3 million Modeling Scenarios Trial 11 Evera Clinical Trial 13 Sprint Quattro, 6947M and 6935M leads Post- Results 12 No -related complications No difference in ventricular pacing capture thresholds or sensing amplitude between the and control groups No impact on detection and therapy delivery 18+ of research experience Industry-exclusive modeling testing safety of over 2.3 MILLION SCANNING SCENARIOS 10 OVER 3,700 patients enrolled in SureScan Pacemaker and ICD PROSPEIVE Clinical Studies 7-9,11,13 6+ of SureScan Pacemaker market experience 350,000+ SureScan Pacemaker and ICD Systems sold worldwide 14 PROVEN 6 7

5 BUILT FOR PHYSIOCURVE TM 30% reduction in skin pressure1 We specifically engineered the Evera SureScan ICDs for the environment, with enhancements that ensure patient safety during an scan.10 Tapered at the header and bottom of device to reduce skin pressure and promote patient comfort Smaller footprint for a smaller incision Designed with lead wrap in mind: Landing area to minimize additional stress on the lead15 We made hardware component changes to ensure high energy fields do not damage circuits and firmware changes, for ease of use.10 Leads: Now with Access Combine SureScan leads with a SureScan device in any combination. 6935M 6947M Defibrillation Leads Designed for Reliability Proven by Active Monitoring (55, 62 cm lengths) With over 10 years of experience, the Sprint Quattro family of leads has proven performance you can depend on for your ICD patients. The 6947M and the 6935M are now approved for use in the MR environment. Pacing Leads The 5076 and 5086 pacing leads have been tested and approved for use in the MR environment. SureScan Systems proven to mitigate the following hazards10: P 8 force, torque and heating P unintended cardiac stimulation P device interactions in the 9

6 SMARTSHOCK 2.0 TECHNOLOGY UNMATCHED ASSURANCE Our performance assurance program demonstrates the confidence we have in SmartShock. We will reimburse up to $500 to any patient with an eligible device* one with SmartShock or SmartShock 2.0 Technology who receives an inappropriate shock, to help cover certain unreimbursed medical expenses incurred while seeking medical care.** Out-of-the-box settings SmartShock is nominally on and clinically proven to reduce shocks INDUSTRY-LEADING PROJEED LONGEVITY AND WARRANTY Incidence of Inappropriate Shock (%) No. at Risk % of dual chamber and triple chamber patients and 97.5% of single chamber patients were free from inappropriate shocks at one year. 2 Inappropriate shock rates for Single, Dual and Triple Chamber ICD patients Single Chamber Dual and Triple Chamber 2.5% 1.5% Months since implant ,885 1,687 1,532 1, % Dual and Triple Chamber 97.5% Single Chamber Evera ICD Projected Longevity 9.7 Projected Longevity Dual Chamber Evera XT and Evera S 11 Projected Longevity Single Chamber Evera XT Projected Service Life (longevity) is based on VVI for VR and DDD for DR devices with 0% pacing from the manuals of the Evera models listed. 16 The Evera S and XT models share the same battery, telemetry and programming features that impact longevity. Industry-Leading Warranties for Evera XT 8 Warranty for Evera XT DR * 10 Warranty for Evera XT VR * * Limited lifetime warranty, some restrictions may apply. The limited lifetime warranty applies to the performance of the device and includes some reimbursement to patients of unreimbursed medical expenses. The warranty is limited to the provisions in the written Limited Warranty document that accompanies each product. Consult the written limited warranty document for details, a copy of which will be provided upon request. * Eligible devices: Viva XT, Viva S, Protecta XT, Protecta ICD CRT-Ds; Evera XT, Evera S, Evera XT, Evera S, Protecta XT, Protecta ICDs. ** SmartShock Technology algorithms must be programmed ON (with parameter settings below) at the time of the inappropriate shock. Medtronic will cover 10 uninsured medical expenses, not to exceed $500, per patient shocked event. This offer is valid for the lifetime of the device. 11

7 References _ 1 Flo, Daniel. Device Shape Analysis. January Medtronic data on file. _ 2 Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm. May 2015;12(5): _ 3 Nazarian S, Reynolds MR, Ryan MP, Wolff SD, Mollenkopf SA, Turakhia MP. Utilization and likelihood of radiologic diagnostic imaging in patients with implantable cardiac defibrillators. J Magn Reson Imaging. Published online J une 27, _ 4 Medtronic data on file 2015: Data from MarketScan 2012 Commercial and Medicare Database, Truven Health Analytics. 5 American College of Radiology, ACR Appropriateness Criteria. Available at Accessed June 29, _ 6 _ 7 Wilkoff BL, Bello D, Taborsky M, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm. January 2011;8(1): Ramza B, et al. Are There Cumulative Effects of Multiple on MR-conditional Pacemakers? Presented at HRS, May Gimbel JR, Bello D, Schmitt M, et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. May 2013;10(5): Gold MR, Kanal E, Schwitter J, et al. Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use. Heart Rhythm. March 2015;12(3): Evaluation of Approved Pacing Lead (Model 5076) for Use in Environment, clinicaltrials.gov, N Gold MR, Sommer T, Schwitter J, et al. Full-Body in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. June 23, 2015;65(24): Confirmatory Clinical Trial of the Evera System for Conditionally-Safe Access, clinicaltrials.gov, N Poor, Corinne. SureScan Units Sold from FY09 FY15. June Medtronic Data on File. 15 Lulic, Tom. Medtronic data on file. March 26, Brief Statement for Evera System The Evera SureScan defibrillation system is MR Conditional and, as such, is designed to allow patients to be safely scanned by an machine when used according to the specified conditions for use. When programmed to On, the SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. Medtronic Canada 99 Hereford Street Brampton, ON L6Y 0R3 Canada Tel: 1(800) medtronic.ca Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) UC bEC Medtronic Minneapolis, MN. All Rights Reserved.