PACING SYSTEMS.
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1 References 1 Ensura SR MRI SureScan EN1SR01 Clinician Manual. 2 Medtronic Adapta ADSR01/03/06 Implant Manual, Advisa MRI SureScan pacing system included on the ARTG 22/8/2009, with full body MRI scan on 11/6/ ark SM, Lazebnik M, Hunt JJ, et al. A path to safe MRI scanning of cardiac pacemaker patients: A role for computer modeling. WCHD. 2012;AB Stone JE, Crossley GH. Current sensor technology for heart rate modulation by artificial pacing. Cardiac Electrophysiology Review. July 1999;3(1): Gimbel JR, et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. May 2013;10(5): 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): Andersen HR, Nielsen JC, Thomsen EB, et al. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. October 25,1997;350(9086): Skanes AC, Krahn AD, Yee R, et al, for the CTO Investigators. rogression to chronic atrial fibrillation after pacing: the Canadian Trial of hysiologic acing. J Am Coll Cardiol. July 2001;38(1): Nielsen JC, Kristensen L, Andersen HR, Mortensen T, edersen OL, edersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. August 20, 2003;42(4): Comment in: J Am Coll Cardiol. 2003;42: Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. June 17, 2003;107(23): Gillis AM, ürerfellner H, Israel CW, et al. Reduction of unnecessary ventricular pacing due to the Managed Ventricular acing (MV) mode in pacemaker patients: Benefit for both sinus node disease (SND) and AV block (AVB) indications. Heart Rhythm. May 2005;2(5):S40. Abstract AB Medtronic EnRhythm 1501DR, Dual Chamber Rate Responsive acemaker with RapidRead Telemetry (OAE-DDDR) Implant Manual. April St. Jude Medical Victory XL DR Model 5816, DR Model 5810, SR Model 5610 ulse Generators with VI Ventricular Intrinsic reference Users Manual. December Boston Scientific Altura 20, Altura 40 Multiprogrammable acemakers System Guide. January Ensura DR MRI SureScan EN1DR01 Clinician Manual. 17 Rosenthal LS, Mester S, Rakovec, et al. Factors influencing pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CATURE Trial. acing Clin Electrophysiol. August 2010;33(8): Australia ABN Medtronic Australasia ty Ltd 97 Waterloo Road North Ryde NSW 2113 Toll Free New Zealand Medtronic New Zealand Limited 5 Gloucester ark Road Onehunga, Auckland NZ Toll Free Brief Statement See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. wwwp.medtronic.com/mrc To view device manuals, please visit website listed above UC a ANZ Medtronic Australasia All Rights Reserved. rinted in Australia. [ ] Ensura MRI SureScan ACING SYSTEMS
2 99% Reduction of unnecessary RV pacing with MV * 35% 1,2 Greater longevity than previous models** INTRODUCING ENSURA MRI Surescan pacing system ortfolio Full Body MRI Full Body MRI Access and a new standard in pacing Technology No Compromise. ACROSS THE CONTINUUM OF CARE. ATIENT SELECTION IMLANT THERAY ATIENT CARE The Ensura SR MRI SureScan and Ensura DR MRI SureScan pacing system is MR Conditional and, as such, is designed to allow patients to be scanned by an MRI machine when used according to the specified MRI Conditions for use. A complete SureScan pacing system, consisting of a SureScan pacemaker and SureScan lead(s), is required for use in the MRI environment. * Ensura DR only. ** Ensura SR only. acemakers Ensura DR MRI SureScan Ensura SR MRI SureScan acing Leads CapSureFix MRI 5086 CapSure Sense MRI 4074 CapSure Sense MRI 4574
3 EVIDENCE and EXERIENCE The SureScan Journey: 17+ years of MRI research, resulting in a portfolio of full featured pacemakers with full body MRI scanning DEVELO: 5086MRI acing Lead and Industry Exclusive Modeling Capability TEST: 5086 Lead with 400,000 Modeling Scenarios VALIDATE: EnRhythm MRI and Advisa MRI Clinical Studies 727 patients First SureScan acemaker System REFINE: Improve Modeling with Accuracy and Speed 2011 Ensura DR MRI TEST: 5076, 4574, and 4074 Leads with 2.3 million Modeling Scenarios 2014 Addition of Ensura SR MRI to the MRI pacemaker portfolio Approved for MRI Use 3 5+ years of SureScan acemaker Market Experience Over 2,700 patients have been studied in three prospective clinical studies 4-6 Industry-Exclusive model testing of over 2.3 million scanning scenarios 4 Available internationally for more than five years with over 200,000 SureScan devices sold 7
4 A NEW Standard in pacing technology All key information on one Quick Look II screen DEVICE CHECK FULLY AUTOMATIC CLINICAL CHECK FULLY AUTOMATIC Atrial* and Ventricular Capture Management (ACM and VCM) automatic threshold measurements and adjustments CareLink Network Remote monitoring capability MV * Reducing unneccesary ventricular pacing has been shown to reduce the risk of AF MV has been shown to reduce unnecessary ventricular pacing. 12 BATTERY LEAD IMEDANCE ACING THRESHOLD SENSING ACING MODE ARRHYTHMIA EISODES ACING/SENSING RELEVANT OBSERVATIONS * Dual chamber only.
5 Managed Ventricular acing (MV) * Exclusive to Medtronic devices is the ONLY mode-switching technology that reduces unnecessary RV pacing by 99%. 12 A atient s Risk of AF Doubles with Ventricular acing (DDD/R) vs. Atrial acing (AAIR). 10 Even with long AV delays, programmed DDD pacing leads to AF 10 Medtronic s MV technology uses AAI(R) primarily with DDD pacing ONLY when necessary 13 Both VI from St. Jude Medical and AVSH from Boston Scientific utilise DDD(R) with long or short AV delay pacing 14,15 Atrial pacing (AAIR) with DDD(R) backup pacing mode reduces the risk of this comorbidity 10 Only Medtronic MV provides 13 Mode-switching technology: AAI(R) with RV pacing only with conduction loss Active AAI mode at all heart rates Average ventricular pacing rate of 0.3% 12 Clear, reliable, evidence through peer-reviewed publications AAI(R) DDD(R) Short AV MV is primarily an AAI mode with backup V. pacing when needed Conduction loss Ensura SR MRI SureScan Extending the SureScan family to patients indicated for single chamber pacing 35% 35% Greater Longevity* versus Adapta SR 9x EGM Storage versus 9x Adapta SR * Dual chamber only. * The service life projections are based on the following assumption. VVIR, 100% pacing, 2.5 V, 60 ppm, 0.4 ms, 500 ohms
6 A NEW STANDARD IN ACING TECHNOLOGY Dual Chamber Feature SureScan Technology Full body MRI access with no position restrictions Complete Capture Management Extends longevity of the device by up to one year 17 Upper Sensor Rate rogrammable olarity May reduce the likelihood for lead modification post-implant MV Reducing unnecessary ventricular pacing has been shown to reduce the risk of AF MV has been shown to reduce unnecessary ventricular pacing. 12 Ensura DR MRI 16 EN1DR bpm EGM Storage/Maximum # of Episodes 15 min/> 200 Longevity VVI, 100% pacing, 2.5 V, 60 ppm, 0.4 ms, 500 ohms 8.7 years Single Chamber Feature SureScan Technology Full body MRI access with no position restrictions Ventricular Capture Management rovides confidence in your patients safety with automatic threshold measurements and adjustments Upper Sensor Rate rogrammable olarity May reduce the likelihood for lead modification post-implant Ensura SR MRI EN1SR bpm EGM Storage/Maximum # of Episodes 7 min/> 25 Longevity VVI, 100% pacing, 2.5 V, 60 ppm, 0.4 ms, 500 ohms 11.7 years
Advisa MRI SureScan. PACING SYSTEMs. References 1
References 1 Zhan C, Baine WB, Sedrakyan A, Steiner C. Cardiac device implantation in the United States from 1997 through 2004: a population-based analysis. J Gen Intern Med. January 2008;23(Suppl 1):13-19.
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