1 MRI. ACCESS . Evera MRI SureScan . ICD Systems MRI 36% of ICD patients are likely to ACCESS . Introducing Evera MRI , have an MRI ordered over 4 years3. featuring SureScan MRI Technology. ICD Patients are not receiving MRIs MRI MRI 36%. CONTOURED. LONG-LASTING. SMART.*. Greater patient comfort So patients can spend The most advanced with 30% reduction in more time living, and less shock reduction suite, Non-ICD Patient Cohort4 ICD Patient Cohort3. skin time receiving device so patients receive N = 9,385 N = 9,385. replacements. fewer inappropriate Data from 2012 were used to project MRI utilization in the ICD. patient cohort over 4 years; whereas the actual MRI utilization rate over 4 years was measured in the non-ICD cohort. The Evera MRI SureScan ICD system is MR Conditional and, as such, is designed to allow patients to be safely scanned by an MRI machine when used according to the specified MRI conditions for use.
2 A complete SureScan ICD system, including the Evera MRI SureScan ICD and one or two SureScan ICD leads, is required for use in the MRI environment. 2 * SmartShock 3. EXPANDING. Non-ICD Patients ICD Patients Stroke patients with an 100%. ICD are not getting ACCESS optimal diagnostic imaging 80% 75%. 72% 72%. 69%. Percent of Patients 44% of non-ICD patients undergo an MRI within 3 days 60%. of stroke or TIA diagnostic 44%. vs. 1% of patients with a Together, we can now traditional 40%. provide ICD patients optimal 20%. imaging ,according to ACR.*5. 1%. 0%. MRI CT Ultrasound 100%. Back Pain 22% of non-ICD patients 80%. undergo an MRI within Percent of Patients 30 days of back pain diagnosis vs. of patients with a 60%. traditional 40%. 32%.
3 29%. 27%. 22% 21%. WITH EVERA MRI 20%. PATIENTS HAVE ACCESS 0%. TO FULL BODY MRI SCANNING6 MRI CT X-ray CT MRI. 100%. Joint Pain (Knees, ankles, elbows, shoulders & wrists). 80%. 17% of non-ICD patients undergo Percent of Patients an MRI within 30 days of joint pain diagnosis vs. of patients 60%. with a traditional Better for bony tissue Superior for soft tissue 40%. Uses ionizing radiation Uses magnetic energy 30% 28%. (multiple CT scans means and RF (no cumulative added risk to patient as dose risk) 20% 17% 16% 19%. x-ray dose is cumulative) Contrast (if used) has Contrast, if used, is iodine low risk based and may cause 0%. allergic reactions MRI CT X-ray 4 * American College of Radiology. 5. PROVEN. EVIDENCE AND EXPERIENCE Evera MRI Clinical Study12.
4 Prospective, randomized study 275 patients at 42 centers globally SureScan Technology No positioning restrictions backed by 5 prospective clinical trials and robust computer modeling Demonstrated that the system is safe and effective DEVELOP TEST EnRhythm MRI SureScan Advisa MRI REFINE TEST 5076 MRI Evera MRI . SureScan Pacing SureScan Lead Clinical Trial7 Post-Approval Clinical Trial9 Improve 5076 Lead, Trial11 Clinical Trial13. Lead and Industry with 400,000 464 SureScan Clinical Study8 263 SureScan Modeling with 6935M Lead, Sprint Quattro MRI , Exclusive Modeling Modeling Patients Patients Accuracy 6947M Lead 6947M and 6935M. Capability Scenarios and Speed with million leads Modeling Scenarios10. 1997 2015. Post-MRI Results12. No MRI-related complications No difference in ventricular pacing capture thresholds or sensing amplitude between the MRI and control groups No impact on detection and therapy delivery 18+ Industry-exclusive modeling testing OVER 6+ 350,000+ PROVEN.
5 YEARS 3,700. safety of over of MRI research experience patients enrolled in YEARS SureScan Pacemaker and ICD. Systems sold worldwide14. MILLION. of SureScan Pacemaker SureScan Pacemaker market experience and ICD PROSPECTIVE. SCANNING 10. Clinical Studies 7-9,11,13. SCENARIOS. 6 7. BUILT PHYSIOCURVE TM. FOR MRI 30% reduction in skin pressure1. We specifically engineered Tapered at the header and bottom of device to the Evera MRI SureScan ICDs reduce skin pressure and promote patient comfort for the MRI environment, with Smaller footprint for a smaller incision enhancements that ensure patient Designed with lead wrap in mind: Landing area to safety during an MRI 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 Leads: Now with MRI ACCESS Combine SureScan leads with a SureScan device in any combination.
6 6935M 6947M Defibrillation Leads Designed for Reliability Proven by Active Monitoring 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. (55, 62 cm lengths). 5086 5076 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 force, torque P unintended cardiac P device interactions and heating stimulation in the MRI. 8 9. SMARTSHOCK INDUSTRY-LEADING. TECHNOLOGY PROJECTED. UNMATCHED ASSURANCE Out-of-the-box settings LONGEVITY. Our performance assurance program demonstrates the confidence we have in SmartShock.
7 We will reimburse up to $500 to any patient with an eligible device*. SmartShock is nominally on and clinically proven to reduce shocks AND WARRANTY. one with SmartShock or SmartShock Technology who receives an inappropriate shock, to help cover certain unreimbursed medical expenses incurred while seeking medical care.**. of dual chamber and Evera MRI ICD Industry-Leading Projected Longevity Warranties for Evera MRI XT. triple chamber patients and of single chamber patients 11. 8 YEARS. were free from inappropriate YEARS. shocks at one Projected Longevity YEARS Single Chamber Evera MRI XT Warranty for Evera MRI XT DR*. Projected Longevity 12 Inappropriate shock rates for Dual Chamber Evera MRI XT and Incidence of Inappropriate Shock (%).
8 Single, Dual and Triple Chamber ICD patients Evera MRI S. 10 YEARS. 10. Single Chamber Dual and Triple Chamber 8. Dual and Triple Warranty for Evera MRI XT VR*. 6 Chamber 4. 2. 0. 0 6 12 18 24. Months since implant Single Chamber rojected Service Life (longevity) is based on VVI for VR and DDD for P *L. imited lifetime warranty, some restrictions may apply. The limited lifetime DR devices with 0% pacing from the manuals of the Evera MRI models warranty applies to the performance of the device and includes some No. at 713 641 590 362 135 The Evera MRI S and XT models share the same battery, reimbursement to patients of unreimbursed medical expenses. The warranty is limited to the provisions in the written Limited Warranty document that Risk 1,885 1,687 1,532 1,121 679 telemetry and programming features that impact longevity.
9 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 MRI XT, Evera MRI 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. References _ 1 . Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file. _9. Gimbel JR, Bello D, Schmitt M, et al. Randomized trial of pacemaker and lead _ 2 . Auricchio A, Schloss EJ, Kurita T, et al.
10 Low inappropriate shock rates in patients system for safe scanning at Tesla. Heart Rhythm. May 2013;10(5):685-691. with single- and dual/triple-chamber implantable cardioverter-defibrillators using 10. Gold MR, Kanal E, Schwitter J, et al. Preclinical evaluation of implantable a novel suite of detection algorithms: PainFree SST trial primary results. Heart cardioverter-defibrillator developed for magnetic resonance imaging use. Rhythm. May 2015;12(5):926-936. Heart Rhythm. March 2015;12(3):631-638. _3. Nazarian S, Reynolds MR, Ryan MP, Wolff SD, Mollenkopf SA, Turakhia MP. _11. Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment, Utilization and likelihood of radiologic diagnostic imaging in patients with , NCT01755143.