Advisa MRI SureScan. PACING SYSTEMs. References 1

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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): National Cancer Institute April US estimated complete prevalence (including counts) by age on 1/1/2006. Based on November 2008 SEER data submission; DCCS, Surveillance Research rogram, Statistical Research and Applications Branch. 3 Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. May 1998;41(5): American Heart Association. Heart Disease and Stroke Statistics 2010 Update: Learn and Live. revalence of stroke by age and sex (NHANES: ). 5 docs/fs_stroke.pdf 6 Gunnarsson C, et al. resented at HRS 2013 (O04-06). 7 Ramza, et al. Are There Cumulative Effects of Multiple MRI on MR-conditional acemakers? resented at HRS Rome, Sarah. Advisa SR MRI SureScan Longevity Calculation. February Medtronic Data On File. 9 Demmer, Wade. Advisa SR MRI SureScan EGM Storage Calculation. February Medtronic Data On File. 10 Adapta/Versa/Sensia Reference Guide. 11 Advisa DR MRI SureScan A2DR01, ADVISA SR MRI SureScan A3SR01 Clinician Manual. 12 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): Stone JE, Crossley GH. Current sensor technology for heart rate modulation by artificial pacing. Cardiac Electrophysiology Review. July 1999;3(1): Nordlander R, Hedman A, ehrsson SK. Rate responsive pacing and exercise capacity a comment. acing Clin Electrophysiol. May 1989;12(5): urerfellner H, Gillis AM, Holbrook R, Hettrick DA. Accuracy of atrial tachyarrhythmia detection in implantable devices with arrhythmia therapies. [published correction appears in acing Clin Electrophysiol. October 2004;27(10):following table of contents]. acing Clin Electrophysiol. July 2004;27(7): Ziegler D, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. December 2006;3(12): Medtronic, Inc. 710 Medtronic arkway Minneapolis, MN USA Tel: (763) Fax: (763) Medtronic USA, Inc. Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) 17 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 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 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): Shenthar J, Milasinovic G, Al Fagih, A, et al. MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: randomized trial results. Heart Rhythm. ublished online December 30, heartrhythmjournal.com/article/s (14) /pdf 22 Data from 2010 MarketScan Commercial and Medicare databases from Truven Health Analytics, Inc. were used to characterize non-pacemaker and pacemaker cohorts and utilization or radiology services. Cohorts were matched based on age, gender, and co-morbidities. 23 Schwitter J, Kanal E, Schmitt M, et al. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. June 2013;10(6): Yokoyama K, Nitatori T, Kanke N, Suzuki S. Efficacy of cardiac MRI in the evaluation of ischemic heart disease. Magn Reson Med Sci. April 2006;5(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 J, Kristensen L, Andersen H, et al. A randomized comparison of atrial and dual chamber pacing in 177 consecutive patients with sick sinus syndrome. J Am Coll Cardiol. August 20, 2003;42(4): 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): The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators (BAATAF). N Engl J Med. November 29, 1990;323(22): assman RS, Weinberg KM, Freher M, et al. Accuracy of mode switch algorithms for detection of atrial tachyarrhythmias. J Cardiovasc Electrophysiol. July 2004;15(7): Boriani G, et al. Atrial Antitachycardia acing and Managed Ventricular acing Reduce the End oint Composed by Death, Cardiovascular Hospitalizations, and ermanent Atrial Fibrillation Compared to Conventional Dual Chamber acing in Bradycardia atients: Results of the MINERVA Randomized Study. AHA Late Breaking Clinical Trial, November 18, UC c EN Medtronic, Inc Minneapolis, MN. All Rights Reserved. rinted in USA. 04/2015 Advisa MRI SureScan ACING SYSTEMs

2 acemaker patients are more likely to need an MRI 86% of pacemaker patients are at least 65 years old and have multiple comorbidities for which MRI may be needed. 1-4 Think Beyond the Heart The revalence of Common Comorbidities Increases Rapidly Over Age % Think Beyond the Heart revalence in US opulation 16% 14% 12% 1 8% 6% 4% Stroke rostate Cancer Osteoarthritis Colorectal Cancer 2% 30s 40s 50s 60s 70s Age by Decade Stroke is a leading cause of death and the leading cause of permanent disability in the United States. 4,5

3 Historically, pacemaker patients are being denied access to MRI % of traditional pacemaker patients 2 get an MRI annually versus 15% of non-pacemaker patients. 6 Now SureScan patients are getting MRI scans of patients with SureScan devices are estimated to undergo an MRI at 24 months post-implant. 7 Think Beyond the Heart acemaker Cohort* (n = 27,580) % of patients with traditional pacemaker receiving an MRI annually Non-acemaker Cohort* (n = 27,580) % of patients receiving an MRI annually MRI Rate Following Implant of Full SureScan System ost-approval Study (n = 2,637) MRI 0.32% MRI 15% * atient cohorts were matched so both represent a group of patients with the same 1) Gender, 2) Age, 3) Major comorbidities. First MRI Occurrence 25% 2 15% 1 5% 20.2% 15.4% 17.5% 12.8% 10.5% 8.3% 5.7% 2.6% Months Since Implant Stroke patients with a pacemaker are not getting optimal diagnostic imaging 49% of non-pacemaker patients undergo an MRI within 3 days of stroke or TIA diagnostic vs. 0.34% of patients with a traditional pacemaker. 6 ercent of atients % 0.34% Non-acemaker acemaker MRI CT Ultrasound Top Imaging Diagnostic rocedures for stroke patients within 3 days of stroke or TIA diagnosis Of those patients receiving a scan, 47% had no previous MRI and/or CT scan prior to implantation of the SureScan pacing system (preliminary results of the SureScan post-approval study). 7

4 Advisa SR MRI SureScan with 5086mri Extending the SureScan family to patients indicated for single chamber pacing Also included in the SureScan family are the Advisa DR MRI and Revo DR MRI SureScan pacemakers. Advisa SR MRI is only approved for use with the 5086MRI lead. * The service life projections are based on the following assumption: VVIR, 10 pacing, 2.5 V, 60 ppm, 0.4 ms, 500 ohms. VVIR only, not AAIR. ** Includes 2 additional minutes of patient-activated episodes viewable only on the CareLink Network. 35% 35% Greater Longevity* versus Adapta SR 8 11x 11x EGM Storage** versus Adapta SR 9 MOST ADVANCED ACING TECHNOLOGY Dual Chamber Feature SureScan Technology Full body MRI access with no position restrictions On Screen Cardiac Compass and Rate Histograms Adapta DR 10 ADDR01 Advisa DR MRI 11 A2DR01 Complete Capture Management roven to extend longevity of the device by up to one year 12 High Upper Tracking Rates rovide pacing support at higher heart rates for active and younger patients 210 bpm 210 bpm Upper Sensor Rate 180 bpm 175 bpm Rate Drop Response May reduce the frequency of syncopal episodes 13,14 rogrammable olarity May reduce the likelihood for lead modification post-implant AF Diagnostics AT/AF Detection Accuracy 15,16 Atrial Reactive AT MV Reducing unnecessary ventricular pacing has been shown to reduce the risk of AF MV has been shown to reduce unnecessary ventricular pacing. 17 EGM Storage/Maximum # of Episodes 48 sec/8 23 min/> 100 atient-activated EGM Viewer Longevity (DDD, 10 pacing, 2.5 V, 60 ppm, 500 ohms) Single Chamber Feature SureScan Technology Full body MRI access with no position restrictions On Screen Cardiac Compass and Rate Histograms Ventricular Capture Management rovides confidence in your patients safety with automatic threshold measurements and adjustments 9.0 years 8.7 years Adapta SR 10 ADSR01 Advisa SR MRI 11 a3sr01 Upper Sensor rate 180 bpm 175 bpm rogrammable olarity May reduce the likelihood for lead modification post-implant EGM Storage/Maximum # of Episodes 48 sec/8 9 min/> 30** atient-activated EGM Viewer Longevity* * VVIR, 10 pacing, 2.5 V, 60 ppm, 0.4 ms, 500 ohms 8.7 years 11.7 years No COMpromises in therapy

5 Supported by extensive evidence AND experience Industry proprietary computer model evaluated more than 2 million scenarios 18 Over 3,600 patients studied in four prospective clinical studies 7,19, % of SureScan MRI pacemaker patients are estimated to undergo an MRI within 24 months post-implant in the US 7 2,637 Currently Enrolled Advisa DR MRI Clinical Trial 19 Advisa MRI SureScan system is safe and effective in the MRI environment rospective, randomized, controlled, multi-center/263 patients Designed to confirm safety, effectiveness, and image quality for MR scans of chest area with no isocenter positioning restrictions Results Safety and Effectiveness No MRI-related complications No difference in pacing capture threshold changes between the MRI and control groups ercent of Subjects % 64% MRI (n = 141) Control (n = 75) 25% 18% 13% 2% 3% 5% 2% 3% Change in Atrial acing Capture Threshold (V) Supported by extensive evidence AND experience 464 SureScan atients Safety and Efficacy rospective, Randomized ublished: 2011, Heart Rhythm EnRhythm DR MRI Trial* SureScan atients Safety and Efficacy rospective, Randomized Advisa DR MRI Trial SureScan atients Safety and Efficacy of 5076 lead in MRI scans rospective, Randomized 5076 MRI Trial 21 MRI-related complications and complication rate for 5086MRI lead Non-randomized, multi-center study regulated by the FDA SureScan post-approval study 7 ercent of Subjects % 63% MRI (n = 149) Control (n = 80) 2 15% 17% 16% 9% 1% 1% 2% 2% 3% 1% 3% 1% Change in Ventricular acing Capture Threshold (V) * This study was conducted with the C1-T12 MRI scan exclusion zone in place.

6 FULL BODY MRI ACCESS No ositioning Restrictions for MR Scans Tested and Approved for Cardiac MRI SureScan devices do not reduce diagnostic quality of Cardiac MRI (CMR) imaging 23 Advisa DR MRI Clinical Study CMR Image Quality Evaluation23 Left ventricular (LV) and right ventricular (RV) cine long-axis No COMpromises in therapy 4 of all MRIs are performed in the torso area. Now, SureScan patients can easily undergo these MRI scans without any positioning restrictions. 22 Advisa DR MRI patients (n = 150) 98% 95% RV LV The Advisa DR MRI clinical study showed that 95 to 98% of cardiac MRI images are of diagnostic quality. 23 The Importance of Cardiac MRI Cardiac MRI (CMR) is emerging as one of the fastest growing new fields of broad MR application 24 CMR can now be used for morphological and functional evaluation of the heart with good reliability and high spatial and temporal resolution 24 Cardiac MRI is employed mainly for assessing ischemic heart disease in a single examination, serving as a true comprehensive cardiac study 24

7 Clinically roven to better Detect and treat Af Advisa dual chamber pacemaker REDUCE DETECT TREAT MV 95% AT/AF Detection Accuracy 19,30 MRI Atrial AT + MV Reducing unnecessary ventricular pacing has been shown to reduce the risk of AF MV has been shown to reduce unnecessary ventricular pacing 17 Appropriate initiation of anticoagulants can reduce the risk of AF-related strokes by up to 8 29 Medtronic pacing devices have less than 5% false positive rates for AF detection. 15,30 Therefore, clinicians can feel confident taking clinical action based on device reported AF without the need for intensive review of individual episodes. 23 minutes of high quality EGM storage visible through the CareLink Network. Cardiac Compass report provides AT/AF burden information. 49% of patients with a stroke or TIA diagnosis receive an MRI within 3 days 6 Exclusive Atrial Reactive AT + Atrial intervention + MV is clinically proven to reduce permanent AF by 61% compared to standard dual chamber pacing 31 Atrial Reactive AT + Atrial intervention + MV = 61% relative reduction in permanent AF 31 MINERVA Study Objective To demonstrate benefit of Atrial AT + Atrial intervention + MV in delaying AF disease progression compared to standard dual chamber pacing Study Design Randomized, prospective, international study Bradyarrhythmia patients with no history of permanent AF or third-degree AV block Results Compared to the Control DDDR patients at 2 years, Atrial AT + Atrial intervention + MV patients experienced: 61% relative reduction in permanent AF 31 52% reduction in AF-related hospitalizations and ER visits 31 Risk of ermanent AF Risk of ermanent Atrial Fibrillation 31 Log Rank p-value comparing Control DDDR Observation eriod (month) Atrial AT + Atrial Intervention + MV 61% relative reduction No COMpromises in therapy

8 Clinically roven to better Detect and treat Af Exclusive Reactive Atrial AT * Offers more opportunities to restore and maintain sinus rhythm In some patients, AT/AF episodes tend to change in pattern and rate. A patient s AF may at one point transition back to AT or to atrial flutter, and then change once again into AF. AF AT AF Changes in a rhythm s regularity and/or cycle length present new opportunities for AT to be successful in terminating the arrhythmia Reactive AT continuously monitors and allows for multiple deliveries of programmed AT therapies for longer atrial episodes if the arrhythmia shifts in rate or regularity In the MINERVA study, increased AT efficacy is associated with lower risk of persistent AF 31 This points to the second generation Atrial Reactive AT s ability to disrupt AT/AF episodes as the likely driver of the results seen in MINERVA Risk of ersistent AF31 (episodes longer than 7 days) Log Rank p-value comparing Control DDDR vs. aat + Atrial Intervention + MV (AT success 43%) aat + Atrial Intervention + MV (AT success > 43%) Observation eriod (month) * The rat studied in the MINERVA trial is available in our Advisa MRI and Revo MRI dual chamber pacemakers. 34% 28% 15% Brief Statement: Advisa DR MRI and Advisa SR MRI SureScan acing Systems The Advisa DR MRI and Advisa SR MRI SureScan pacing systems are MR Conditional, and as such designed to allow patients to undergo MRI under the specified conditions for use. A complete SureScan pacing system, which consists of an approved combination (see MRI SureScan device with SureScan lead(s), is required for use in the MRI environment. Consult the device manuals to ensure all system components are MR Conditional. Indications: The Advisa DR MRI SureScan Model A2DR01 and Advisa SR MRI SureScan Model A3SR01 IGs are indicated for use as a system. A complete SureScan pacing system, including an Advisa MRI SureScan IG and SureScan lead(s), are required for use in the MRI environment. The Advisa DR MRI and Advisa SR MRI SureScan systems are indicated for the following: Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity Accepted patient conditions warranting chronic cardiac pacing include: Symptomatic paroxysmal or permanent second- or third-degree AV block Symptomatic bilateral bundle branch block Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias The Advisa DR MRI device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: Various degrees of AV block to maintain the atrial contribution to cardiac output VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm Vasovagal syndromes or hypersensitive carotid sinus syndromes Antitachycardia pacing (AT) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications. Contraindications: The Advisa DR MRI and Advisa SR MRI SureScan systems are contraindicated for: Concomitant implantation with another bradycardia device Concomitant implantation with an implantable cardioverter defibrillator There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implantprocedure used by the physician. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance AT therapy is contraindicated in patients with an accessory antegrade pathway Warnings and recautions: Changes in patient s disease and/or medications may alter the efficacy of the device s programmed parameters. atients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device should not change the application of established anticoagulation protocols. atients and their implanted systems must be screened to meet the following requirements: no lead extenders, lead adaptors or abandoned leads no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history a SureScan pacing system that has been implanted for a minimum of 6 weeks a SureScan pacing system implanted in the left or right pectoral region pace polarity parameters set to Bipolar for programming MRI SureScan to On pacing capture thresholds of 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms) a lead impedance value of 200 ohms (Ω) and 1500 Ω no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on otential Complications: otential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. otential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. The SureScan system has been designed to minimize potential complications in the MRI environment. otential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse. See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at 1 (800) and/or consult Medtronic s website at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.