Victory on demand, time and time again
Contents
1. Victory DR 6 9 years w AC 6 2 years w o AC EnPulse E2DR21 5 7 years w CM 5 5 years w o CM AC AutoCapture Algorithm CM Capture Management 30 31 Victory DR vs Philos II DR vs Symphony DR Device Feature or Therapy Victory DR Philos II DR Symphony DR 5816 XL DR 341 826 2550 5810 DR AF Prevention Therapy Clinically proven AF Suppression Beat by Beat AutoCapture Pacing System Ventricle v Active Capture Control limited Auto Threshold Rate Smoothing v Automatic V Capture Threshold Search v v v Auto Mode Switch v v v AMS Base Rate v Auto Sensitivity Measurement Adjustment v Auto Sleep Rest Mode Sensor controlled Clock Controlled MV Sensor controlled Rate Hysteresis with Programmable Search v y Advanced Hysteresis v v DDD AMC Mode w acceleration Ventricular Intrinsic Preference VIP A AV Hysteresis DDD AMC Mode Negative AV PV Hysteresis v v Programmable Atrial Absolute Refractory Period v v Auto Rate Adaptive AV PV Delay v y Auto PMT Intervention v v PVC Response v v Non Competitive Atrial Pacing v Rate Adaptive Pacing Sensor Accelerometer Accelerometer MV Accelerometer Rate Responsive PVARP v Auto Far Field Protection v Automatic Rate Adaptive Pacing v v Sensor Passive Sensor Behavior Prediction Clinical programming Diagnostics and Follow up AF Suppression2. 50 Pre Detection amp 50 Post Detection A 120 sec 120 seconds 12 sec pre trigger V 120 sec 12 EGMs 10 sec each and 4 sec post trigger A amp V 48 sec with 245 events Custom 120 sec 6 4 min EGM Full Page 8 5 x 11 Printouts v Electronic Calipers v Non Invasive Programmed Stimulation NIPS v v v PMT Counter A Longevity Estimate v v Real Time Extended Markers v Summary Screen FastPath Summary Up to 24 Alerts with Alerts Previous Test Results v Other Weight Volume Victory XL DR Philos II DR Symphony DR 23 5 gm 11 cc 26 0 gm 10 0 cc 24 gm 10 4 cc Victory DR 18 gm 8 cc Longevity 100 pacing 60 ppm Victory XL DR Philos II DR Symphony DR AC Off A amp V 2 5 V 500 Q amp PW 0 4 ms AC On A 2 5 V V 1 V 500 Q amp PW 0 4 ms 12 3 years w AC 11 0 years w o Victory DR 6 9 years w AC 6 2 years w o AC 5 5 years 3 6 V 11 5 years 0 35 ms AC AutoCapture Algorithm 34 35 References 1 Huegl R Israel C Lawo T Unteger C Kennis I Warman E Lauer B Center Clinic Bad Berka Bad Berka Germany Does pace termination of atrial arrhythmias influence time of recurrence Results of the European AT500 verification study PACE 2002 25 4 Part II abstract 538 657 2 Lee MA Weachter R et al Can preventative and antitachycardia pacing reduce the frequency and burden of atrial tachyarrhythmias The ATTEST study results PACE 2002 25 4 P
3. ADx DR Identity DR Victory DR 18 gm 8 cc 18 gm 8 cc 18 gm 8 cc Longevity 100 pacing 60 ppm Identity ADx XL DR Identity XL DR Victory XL DR AC Off A amp V 2 5 V 500 Q amp PW 0 4 ms AC On A 2 5 V V 1 V 500 Q amp PW 0 4 ms 12 3 years w AC 11 0 years w o Identity ADx DR 6 9 years w AC 6 2 years w o AC 12 3 years w AC 11 0 years w o AC Identity DR 6 9 years w AC 6 2 years w o AC 12 3 years w AC 11 0 years w o AC Victory DR 6 9 years w AC 6 2 years w o AC AC AutoCapture Algorithm 22 23 Victory DR vs Insignia Ultra DR vs EnPulse DR Device Feature or Therapy Victory DR Insignia Ultra EnPulse 5816 XL DR 1291 E2DR01 5810 DR 1290 E2DR21 AF Prevention Therapy Clinically proven PMOP AF Suppression Beat by Beat Ventricular AutoCapture v Automatic Capture Not beat by beat Capture Management Atrial Capture Management v Automatic V Capture Threshold Search v v Limited Auto Mode Switch v A v AMS Base Rate v Ventricular Rate Regulation Ventricular Response Pacing Auto Sensitivity Measurement Adjustment A v Auto Sleep Rest Mode Sensor controlled Clock controlled Rate Hysteresis with Programmable Search A Sinus Preference Advanced Hysteresis Sudden Brady Response Rate Drop Response Ventricular Intrinsic Preference VIP AV Search Search AV Negative AV PV Hysteresis Programmable Atrial Absolute
4. DR Victory XL DR EnRhythm Pacemakers 5810 5816 P1501DR Dimensions mm 43 h x 44 1 x 6 t 44x52x6 45x51x8 Mass gm 18 gm 23 5 g 21gm Volume cc 8 cc ll cc 13 cc Longevity years 6 2 years 11 0 years 10 5 years 2 5 V A amp V 500 Q 60 ppm 100 DDD pacing internal comparison Medtronic EnPulse Pacemaker Model E2DRO1 Medtronic s position The world s first fully automatic pace maker designed to optimize therapy and simplify care As the first ever completely automatic pacemaker the EnPulse device offers exclusive features that make it sophisticated yet simple to use It performs a wide range of diagnostic tests on a regular basis without clinician intervention This allows more time to focus on the patient less time on the device EnPulse Pacemaker Key Features Tachyarrhythmia Prevention Algorithms Post Mode Switch Overdrive Pacing Non Competitive Atrial Pacing Miscellaneous Key Algorithms Lead Monitor Automatic Polarity Confirmation Atrial Capture Management Ventricular Capture Management Sensing Assurance Search AV Ventricular Response Pacing Diagnostics Search AV Histograms Atrial Arrhythmia Trend Ventricular Rate Histogram during Atrial Arrhythmias Atrial Arrhythmia Durations Lead Impedance Sensitivity Trend EnPulse Pacemaker Opportunities and Weaknesses A bipolar lead required EGM onset decreases longevity by one day fo
5. 18 gm 23 5 g 26 gm Volume cc 8 cc ll cc 14 1 cc Longevity years 6 2 years 11 0 years 5 8 years 2 5 V A amp V 500 Q 60 ppm 100 DDD pacing ay internal comparison Guidant Insignia Ultra Pacemaker Model 1290 Guidant s position Guidant s best MV blended sensor pacemaker just got better Insignia Ultra Pacemaker Key Features Tachyarrhythmia Prevention Algorithms No atrial arrhythmia prevention algorithm available Miscellaneous Key Algorithms Automatic Capture Auto Sense Algorithm Rate Smoothing Ventricular Rate Regulation Diagnostics Quick Check Arrhythmia Logbook e Activity Log Daily Measurement Data Insignia Ultra Pacemaker Opportunities and Weaknesses There is very limited clinical experience with the Ventricular Automatic Capture algorithm Blended sensors are touted as clinically superior but they can be complicated and time consuming to set up Both accelerometer and minute ventilation sensors signifi cantly improve patient activity and symptoms when used separately their additional combination and optimization through blending do not provide any additional benefit We found no significant differences among the three most utilized sensors in clinical endpoints Those patients who received blended sensors had worse physical function quality of life scores However clinical selection of the most sophisticated sensor for the most ill patients cannot
6. A amp V 2 5 V 500 Q amp PW 0 4 ms AC On A 2 5 V V 1 V 500 Q amp PW 0 4 ms CM On A 2 5 V V 1 5 V 500 Q amp PW 0 4 ms AuC On A 2 5 V V 1 0 V 500 Q amp PW 0 4 ms 12 3 years w AC 11 0 years w o Victory DR 6 9 years w AC 6 2 years w o AC 9 5 years w AuC 8 5 years w o AuC Insignia Ultra 1290 6 7 years w AuC 6 0 years w o AuC 7 9 years w CM 7 5 years w o CM EnPulse E2DR21 5 7 years w CM 5 5 years w o CM AC AutoCapture Algorithm CM Capture Management AuC Automatic Capture 26 Victory DR vs EnRhythm DR vs EnPulse DR Device Feature or Therapy AF Prevention Therapy Victory DR 5816 XLDR 5810 DR Clinically proven AF Suppression EnRhythm DR P1501DR Atrial Rate Stabilization Atrial Preference Pacing EnPulse E2DRO01 E2DR21 PMOP PMOP Beat by Beat AutoCapture Pacing System Ventricle v Not beat by beat Capture Management Atrial Capture Management v Automatic V Capture Threshold Search v Limited Auto Mode Switch v v v AMS Base Rate v Ventricular Response Pacing Auto Sensitivity Measurement Adjustment v v Auto Sleep Rest Mode Sensor controlled Clock controlled Rate Hysteresis with Programmable Search v v Sinus Preference Advanced Hysteresis v Rate Drop Response Ventricular Intrinsic Preference VIP v Manage
7. ST JUDE MEDICAL Victory on demand time and time again Victory Pacemaker Family ST JUDE MEDICAL Cardiac Rhythm St Jude Medical AB Management Division Veddestavagen 19 15900 Valley View Court SE 175 84 Jarfalla Sylmar CA 91342 USA SWEDEN Pocket Sales Guide 1 888 SJM CRMD 46 8 474 4000 818 362 6822 46 8 760 9542 Fax 818 362 7182 Fax For SJM Personnel Only www sjm com Ordering No N0738 Printed in USA 12051 5 Consult the User s Manual for information on indications contraindications warnings and precautions Unless otherwise noted or indicates that the name is a trademark of or licensed to St Jude Medical or one of its subsidiaries 2005 St Jude Medical Cardiac Rhythm Management Division All rights reserved Table of Contents Victory Pacemaker Family Introduction 2 Key Messages and Benefits 2 Victory Pacemaker Overview 3 Competitive Overview 5 Medtronic 5 Guidant 10 Biotronik 11 ELA 12 Competitive Key Selling Points 12 Medtronic 12 Guidant 15 Biotronik 16 ELA 16 Victory Device Questions and Answers 17 St Jude Medical Device Comparison Charts 20 Competitive Device Comparison Charts 24 References 36 Caution It is illegal to promote unapproved devices or features or make unapproved claims about medical devices This material is intended exclusively to provide information and training to St Jude Medical personnel agents representatives and distributors and as such
8. t clinically proven Several studies including the Medtronic AT500 Device Verification study 325 patients p lt 0 89 ATTEST 370 patients p lt 0 25 and ASPECT 288 patients demonstrated no significant difference in the mean number or frequency of AT episodes or AT burden when comparing ATP in the On group versus the Off group The ATTEST study demonstrated an increase in AF Burden 71 of the patients had an increase in recurrent AT after the use of PMOP The MVP algorithm allows two out of four beats to be non supported in the ventricle prior to switching back to DDD Results of the MVP pilot study show your current AICS algorithm is very competitive 96 1 of AP VS intervals recorded were lt 350 ms within AICS range 90 of ventricular rates lt 90 bpm within AICS range Symptomatic patients missed ventricular beats mitral valve regurge and retrograde conduction my not be the therapy your physicians are looking for Keep in mind the studies demonstrated gt 40 RV pacing increases risk In patients with intact sinus conduction right ventricular RV pacing gt 40 leads to an increase in death and heart failure hospitalization In patients with sinus node dysfunction right ventricular RV pacing lt 40 resulted in measurably less risk of HF hospitalization If your patient is symptomatic with the MVP feature you have no other option Size and Shape Victory
9. Refractory Period v v Rate Adaptive AV PV Delay Dynamic AV Delay v PMT Intervention v v PVC Response v v Non Competitive Atrial Pacing Atrial Protection Interval Atrial Flutter Response v Rate Adaptive Pacing Sensor Accelerometer MV Accelerometer Accelerometer Rate Responsive PVARP Far Field Protection Dynamic PVARP Varied amp Auto Automatic Rate Adaptive Pacing Auto Lifestyle v Sensor Passive Sensor Behavior Prediction Expert Ease Exercise test Diagnostics and Follow up AF Suppression Histogram AF Suppression Histogram Event Counts AT AF Episodes Histogram v Limited Atrial Arrhythmia Trend Ventricular Capture Threshold Monitoring Weekly Threshold Trend Daily Measurements Capture Management Trend Auto P amp R Wave In and Out of Clinic A v Rate Histogram v v Sensor Indicated Rate Histogram Activity Log v Lead Monitor amp Trends v v V Rate during AMS Histogram v v Mode Switch Histogram v v Patient Triggered Stored EGM v v Limited AMS Log AT AF Episodes Log 32 episodes 16 frozen 16 FIFO time date duration and max A rate 40 episodes Inclusive of EGM Storage Total time Max Time Average Time 16 episodes time date duration max A rate Also max V rate avg V rate sensor rate 24 25 Victory DR vs Insignia Ultra DR vs EnPulse DR Device Feature or Therapy Victory DR Insignia Ultra EnPu
10. is not to be given distributed provided or discussed with customers or any third parties Introduction This guide is intended to be used as a quick reference tool that you can easily access The information is intended to help you answer common questions and address objections Please refer to the product and competitive overview document on my sjm com for more comprehensive information Key Messages and Benefits The Victory pacemaker s ability to measure thresholds and intrinsic events out of clinic enables the physician to save clinic time This in combination with all of the features from the fully equipped Identity ADx pacemaker as well as the unbeat en longevity of St Jude Medical pacemakers will enable St Jude Medical to define a new state of the art for pacemakers Less Unnecessary Ventricular Pacing St Jude Medical demonstrated in the DAVID Dual Chamber And VVI Implantable Defibrillator study that excessive ventricular pacing may contribute to heart failure in some patients The Ventricular Intrinsic Preference VIP algorithm adds enhanced flexibility to years of clinical experience with AutoIntrinsic Conduction Search technology to encourage the patient s intrinsic ventricular conduction to prevail Less Time at Follow Up Upon interrogation the Victory device displays the last measured sense and capture threshold ventricular only results obtained automatically within the last 24 hours The
11. the AT AF episode terminated Therefore your AMS episodes may be higher than your AT AF episodes The percent of time between AMS and AT AF should be very close How do VIP technology and Rate Responsive AV PV interact If VIP and RRAV PV are both programmed On the below interaction may take place Keep in mind that VIP technology is now active up to 110 ppm and Rate Responsive AV PV activates at 90 ppm so in essence you have a 20 ppm overlap These two algorithms are combined to give you the operating AV delay Here is the formula Programmed AV Rate Responsive AV Ventricular Intrinsic Preference Programmed AV delay 200 ms Rate Responsive AV PV delay Medium 2 ms beat over 90 ppm Ventricular Intrinsic 100 ms delta Preference Current operating rate 100 bpm 200 20 100 280 ms for operating AV delay for that beat 17 How and when are follow up EGMs generated in P R wave tests The device dictated P R wave measurements are attempted once every 23 hours In order to make a daily measurement five P R waves are measured and a minimum maximum and median are calculated The five waveforms displayed as follow up EGMs are the five P R waves that were measured in order to determine the minimum maximum and median for one daily measurement These measurements are internal to the device and a weekly median is displayed to the user via the trend How many intrinsic events are monitored before one P R wave
12. 399 patients p lt 0 05 25 and 65 respectively 7 Insignificant ATP algorithms The Medtronic AT500 pacemaker verification study 325 patients p lt 0 89 and the ATTEST trial 370 patients p lt 0 25 showed no significant difference in the mean number of AT episodes or AT burden when comparing ATP in the On group versus the Off group In another clinical trial called the ASPECT 288 patients investigators found similar results with no clinical significant 8 Why pay for ATP if it doesn t help clinically ATP doesn t work on AF ATP doesn t reduce the re initiation of AF 9 A dedicated bipolar device offers no option if a lead is damaged on the outer coil 13 Selling Against the EnPulse Pacemaker 1 No dual SEGMs The user has to select atrial or ventricular SEGM dual chamber SEGMs are still unavailable 2 Modifications to capture management algorithm The Ventricular Capture Management algorithm required changes due to the evoked response undersensing that was taking place in the Kappa family of devices We re still uncertain if customers will try it after the enhancement was made to the algorithm 3 Expensive This is the top tier device and very expensive 4 Auto Sensing This feature is susceptible to inappropriate pathological sensing resulting in inappropriate therapy to the patient 5 Enhanced Search AV An enhancement added to the EnPulse device over the Kappa family of devices w
13. Histogram v AF Suppression Histogram Event Counts v AT AF Episodes Histogram v v Ventricular Capture Threshold Monitoring Weekly Threshold Trend ACC Threshold Trends V Threshold Auto P amp R Wave Measurements Device based Trend Device based Trend Device based Trend Rate Histogram v v v Sensor Indicated Rate Histogram v v v Lead Monitor amp Trends v v V Rate during AMS Histogram A v v Mode Switch Histogram A v v Patient Triggered Stored EGM v v AMS Log 32 episodes 64 episodes Date of 1st atrial 16 frozen 16 FIFO all being FIFO arrhythmia of AMS AT AF Episodes Log time date duration Atrial Extrasystoles episodes and total and max A rate max V rate avg V rate Statistics AES A Fib A Flutter Tach Zone changes V Rate vs A Rate time in AMS 32 33 Victory DR vs Philos II DR vs Symphony DR Device Feature or Therapy Victory DR Philos II DR Symphony DR 5816 XL DR 341 826 2550 5810 DR Diagnostics and Follow up continued Stored IEGM Trigger Counter v Ventricular High Rate Episode Log Counter IEGM v v IEGM Trigger Options Patient Magnet Patient Magnet Atrial Bursts High Atrial Rate High A Rate Mode Switch High Ventricular Rate High V Rate Episodes AMS Entry AMS Entry Ventricular Bursts AMS Exit PMT Termination IEGM Storage Time PMT Termination PVCs 2 to 5 Adv Hysteresis AT AF Detection Rolling or Frozen Dual IEGM available Up to 24 episodes
14. It does not offer a Capture Management Rate Drop or Sleep Rate algorithm The Victory Team ADx and Identity pacemaker families are the only devices that offer premier bradycardia features including the AutoCapture pacing system Advanced Hysteresis Rest Rate and the Accelerometer sensor It also has the only FDA approved prevention algorithm designed to suppress atrial fibrillation Remember The Medtronic AT500 pacemaker will only deliver ATP Therapy if an episode is classified as AT by the device Episodes classified as AF will be monitored Guidant Selling Against the Insignia Ultra Pacemaker 1 Dual sensors Dual sensors can be very complicated to set up appropriately and even more difficult to optimize 2 Automatic Capture algorithm The Insignia Ultra is the first generation device to enter the market with this feature Therefore it lacks the ten years plus of clinical success that our AutoCapture pacing system has demonstrated 3 Rate Smoothing This feature is functional except during the 8 cycles of Search Hysteresis during ATR fallback until fall back reaches ATR lower limit or the SIR upon triggering of the PMT termination algorithm Sudden Brady Response and when Ventricular Rate Regulation is active in a dual chamber mode 4 Automatic Capture This feature only incorporates a fixed pulse width value whereas the AutoCapture pacing system offers flexibility with a programm
15. Longevity years 6 2 years 11 0 years 5 5 years 2 5 V A amp V 500 Q 60 ppm 100 DDD pacing 6y internal comparison 11 ELA Symphony DR Pacemaker Model 2550 Philos II Pacemaker Key Features Miscellaneous Key Algorithms Symphony DR Pacemaker Model 2550 Diagnostics CLIP Ventricular Threshold Follow Up lt Autosensing Histograms AIDA Symphony Pacemaker Opportunities and Weaknesses Dual sensor can be complicated and time consuming to set up It is not a strong competitor because the devices and features are unfamiliar unknown Size and Shape Victory DR Victory XL DR Symphony Pacemakers 5810 5816 2550 43 h x 44 1 x 6 t 44x52x6 53 1 x 36 2 x 6 4 Longevity years 6 2 years 11 0 years 11 5 years 2 5 V A amp V 500 Q 60 ppm 100 DDD pacing internal comparison 0 35 ms Competitive Key Selling Points Medtronic Selling Against the EnRhythm Pacemaker 1 What about MVP technology Is this the therapy that your physicians are looking for Are you willing to intermittently not support the ventricle MVP creates short long short intervals Maximum pause between V events is 2x lower rate 80 ms e MVP risks remaining in AAIR during first degree AV block MVP has a MTR limitation MVP is not easier to use All DDDR parameters are still necessary MVP is not a simple algorithm Complex criterion to swit
16. able pulse width and amplitude 5 AV Search Hysteresis This feature is limited to 300 ms 15 Biotronik Selling Against the Philos II Pacemaker 1 The Philos II device is very heavy and has poor longevity 5 5 years 3 6 V 2 Only five SEGM triggers are available 3 Even though the device monitors the ventricle on every beat it only does a threshold search at pre set times to adjust the primary output pulse amplitude 4 There is no clinical experience since this is the first generation device with the Active Capture Control feature 5 No atrial arrhythmia prevention algorithm ELA Selling Against the Symphony Pacemaker 1 Auto Mode Switch ELA automatically suspends atrial tracking from the first premature atrial beat preventing palpitations resulting from Wenckebach during the detection interval The Symphony device mode switches for any sustained atrial arrhythmia gt 120 ppm Yes it simplifies the programming but clinical studies have shown the lower the mode switch rate the higher the number of recorded inappropriate episodes This also doesn t allow the physician flexibility to program an atrial tachycardia detection rate that is more tailored to the patient s needs 2 Auto Threshold The device checks the threshold only four times a day but delivers the high amplitude back up when capture isn t confirmed Patients may be pacing at high output for extended periods of time which may negatively i
17. and Follow up continued Selectable Stored IEGMs Up to 12 Up to 12 Up to 12 Stored IEGM Trigger Counter v y v Ventricular High Rate Episode Log Counter IEGM Counter IEGM Counter IEGM Patient Magnet Patient Magnet Patient Magnet High Atrial Rate High Atrial Rate High Atrial Rate High Ventricular Rate High Ventricular Rate High Ventricular Rate IEGM Trigger Options AMS Entry AMS Entry AMS Entry AMS Exit AMS Exit AMS Exit PMT Termination PVCs 2 to 5 Adv Hysteresis AT AF Detection PMT Termination PVCs 2 to 5 PMT Termination PVCs 2 to 5 Adv Hysteresis AT AF Detection IEGM Storage Time 50 Pre Detection amp 50 Post Detection Automatic Follow Up Rolling or Frozen A 120 sec V 120 sec A amp V 48 sec Custom 120 sec Rolling or Frozen A 120 sec V 120 sec A amp V 48 sec Custom 120 sec Rolling or Frozen A 120 sec V 120 sec A amp V 48 sec Custom 120 sec Full Page 8 5 x 11 Printouts Electronic Calipers Non Invasive Programmed Stimulation NIPS SINNS NIN SNS SINNS PMT Counter Longevity Estimate Real Time Extended Markers SINIS NINIS SINIS Summary Screen FastPath Summary FastPath Summary FastPath Summary with Alerts with Alerts with Alerts Previous Test Results v v v Other Weight Volume Identity ADx XL DR Identity XL DR Victory XL DR 23 5 gm 11 cc 23 5 gm 11 cc 23 5 gm 11 cc Identity
18. art II 3 Padeletti L Purerfellner H Adler S Waller T Harvey M Horvitz L Holbrook R Kempen K Mullen A Hettrick D Combined efficacy of atrial septal lead placement and atrial pacing algorithms for the prevention of paroxysmal atrial tachyarrhythmias J Cardiovasc Electrophysiol 2003 14 11 4 Israel DW Gronefeld G Ehrlich JR et al Impact of dedicated pacing algorithm for prevention of early relapse of atrial tachyarrhythmias after successful atrial antitachycardia pacing Circulation 2001 104 345 5 Sweeney et al Randomized pilot study of a new atrial based minimal ventricular pacing mode in dual chamber implantable cardioverter defibrillators Heart Rhythm 2004 1 16 167 6 The DAVID Investigators Dual chamber pacing or ventricular back up pacing in patients with an implantable defibrillator JAMA December 2002 228 24 3115 3123 7 Sweeney MO Helkamp AS Ellenbogan KA et al Mode Selection Trial Investigators 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 2003 107 23 2932 2937 Epub 2003 8 Berg M Frohlig G Schwerdt H Becker R Schieffer H Reliability of an automatic sensing algorithm PACE 1992 15 11 pt 2 1880 5 9 Castro A Liebold A Vincente J Dungan T Allen JC Jr Evaluation of autosensing as an automatic means of maintaining a 2 1 sen
19. be excluded as an explanation of these results There is no atrial prevention algorithm AV Search Hysteresis is limited to 300 ms Size and Shape Victory DR Insignia Ultra Victory XL DR Pacemakers 5810 1290 5816 Dimensions mm 43 h x 44 1 x6 t 44x 42x8 44x52x6 49x 43x8 18 gm 25 48 23 5 29 6 g 8 cc 10 8 cc ll cc 12 6 cc Longevity years 6 2 years 6 0 years 11 0 years 8 5 years 2 5 V A amp V 500 Q 60 ppm 100 DDD pacing internal comparison 10 Biotronik Philos II DR Pacemaker Model 341 826 Biotronik s position Philos II Offering a better view Philos II Pacemaker Key Features Tachyarrhythmia Prevention Algorithms Preventative Overpacing Miscellaneous Key Algorithms Active Capture Control Rate Fading Diagnostics AF Classification VES Classification Impedance Trend AV Rate Trend Philos II Pacemaker Opportunities and Weaknesses Active Capture Control only periodically adjusts the primary pulse amplitude It is approximately 10 heavier with much less longevity It is not a strong competitor because the devices and features are unfamiliar unknown The atrial prevention algorithm isn t clinically proven to be effective Size and Shape Victory DR Victory XL DR Philos II DR Pacemakers 5810 5816 341 826 43 h x 44 1 x 6 t 44x52x6 42x51x8 Mass gm 18 gm 23 5 g 26 0 g ll cc 10 cc Volume cc 8 cc
20. ch between DDDR and AAIR and vice versa Even in AAIR there needs to be ventricular sensing with ventricular blanking periods 12 If patients are symptomatic with MVP there is no other option Results of the MVP pilot study show 96 1 of AP VS intervals recorded were lt 350 ms within AICS range 90 of Ventricular rates lt 90 bpm within AICS range 2 Capture management algorithm It is not available in either chamber 3 Longevity impact Pre arrhythmia SEGM impact longevity by approximately 33 or by four months per year based on device modeling with 50 atrial pacing and 5 ventricular pacing Note The pre arrhythmia EGM feature does not apply to AT AF Episodes The device stores up to five seconds of EGM prior to AT AF detection regardless of the pre arrhythmia settings 4 Size matters The EnRhythm device may weigh less but is 25 thicker and 15 larger than our XL device 5 New algorithms It appears that Medtronic just bundled already existing algorithms in a different package 6 Clinical effectiveness of atrial arrhythmia prevention algorithms questionable In the Medtronic AT500 pacemaker verification study 325 patients p lt 0 89 and the ATTEST trial 370 patients p lt 0 25 showed no significant difference in AT frequency and burden when compared to the On group versus the Off group ADOPT A trial showed AF Suppression to be clinically significant in decreasing AF and AT burden
21. d Ventricular Pacing Search AV Negative AV PV Hysteresis v Programmable Atrial Absolute Refractory Period A v A Rate Adaptive AV PV Delay v v v PMT Intervention v A v PVC Response v v v Non Competitive Atrial Pacing v v v Rate Adaptive Pacing Sensor Accelerometer Accelerometer Accelerometer Rate Responsive PVARP A Dynamic PVARP Varied amp Auto Far Field Protection v Automatic Rate Adaptive Pacing v Auto Lifestyle v Sensor Passive v Sensor Behavior Prediction v Expert Ease Exercise test Diagnostics and Follow up AF Suppression Histogram v AF Suppression Histogram Event Counts v AT AF Episodes Histogram v Histogram amp Trend Atrial Arrhythmia Trend Ventricular Capture Threshold Monitoring Weekly Threshold Trend Capture Management Trend Auto P amp R Wave Measurements Device based trend Device based trend A Rate Histogram v v v Sensor Indicated Rate Histogram v v v Lead Monitor amp Trends v v V Rate during AMS Histogram v A v Mode Switch Histogram v v Patient Triggered Stored EGM A Limited AMS Log AT AF Episodes Log 32 episodes 16 frozen 16 FIFO time date duration and max A rate 16 episodes time date duration max A rate Also max V rate avg V rate sensor rate 28 29 Victory DR vs Insignia Ultra DR vs EnPulse DR Device Feature or Therapy Victory DR EnRhythm DR EnPulse 5816 XL DR P1501DR E2DR01 5810 DR E2DR21 Diagnostics and Follow up continued Stored IEGM Tr
22. dtronic s position New devices offer MVP pacing mode to automatically minimize unnecessary right ventricular pacing In addition to minimizing right ventricular pacing the new EnRhythm pacemaker has reactive anti tachycardia pacing which continually searches for new opportunities to restore a patient s normal sinus rhythm during long atrial tachycardia episodes It also offers enhanced diagnostic features especially for patients who may have additional rhythm problems in the upper chambers of the heart as well as improved longevity EnRhythm Pacemaker Key Features Tachyarrhythmia Therapy Algorithms Antitachycardia pacing ATP therapy Reactive ATP Tachyarrhythmia Prevention Algorithms lt Atrial Preference Pacing Atrial Rate Stabilization Post Mode Switch Overdrive Pacing Miscellaneous Key Algorithms Auto Adjusting Sensitivity MVP Managed Ventricular Pacing Ventricular Rate Stabilization Diagnostics Cardiac Compass trends Episode data and EGM storage gt 16 minutes EnRhythm Pacemaker Opportunities and Weaknesses Bipolar lead required Pre arrhythmia SEGMs impact longevity by approximately 33 or by four months per year based on device modeling with 50 atrial pacing and 5 ventricular pacing Note The Pre Arrhythmia EGM feature does not apply to AT AF Episodes The device stores up to five seconds of EGM prior to AT AF detection regardless of the pre arrhythmia settings ATP isn
23. hich allows the AV delay to extend by 62 ms rather than 31 ms Selling Against the Medtronic AT500 Pacemaker Poor diagnostics The diagnostics of the Medtronic AT500 pacemaker are extensive but very difficult to interpret for a physician that is only familiar with bradycardia devices not using defibrillators Very difficult to program and not easy to use the diagnostics have also been shown in clinical studies to be extremely inaccurate In addition the stored EGMs cause significant battery drain 2 Insignificant prevention pacing algorithms The Medtronic AT500 pacemaker verification study 325 patients p lt 0 89 and the ATTEST trial 370 patients p lt 0 25 showed no significant difference in AT frequency and burden when comparing the On versus the Off group The ADOPT A trial showed AF suppression to be clinically significant in decreasing AF and AT burden 399 patients p lt 0 05 25 and 65 respectively 3 Insignificant ATP algorithms The Medtronic AT500 pacemaker verification study 325 patients p lt 0 89 and the ATTEST trial 370 patients p lt 0 25 showed no significant difference in the mean number of AT episodes or AT burden when comparing ATP in the On versus the Off group In the ASPECT clinical trial 288 patients investigators found similar results with no clinical significant 14 4 Poor bradycardia features The Medtronic AT500 pacemaker is a limited bradycardia pacemaker
24. igger Counter v v v Ventricular High Rate Episode Log Counter IEGM Counter IEGM Counter IEGM IEGM Trigger Options Patient Magnet VT Monitor High Atrial Rate High Atrial Rate SVT High Ventricular Rate High Ventricular Rate VT NS AMS Entry Treated AT AF AMS Exit Monitored AT AF PMT Termination Fast A amp V PVCs 2 to 5 Adv Hysteresis AT AF Detection IEGM Storage Time Rolling or Frozen 10 sec prior to detection Rolling or Frozen 50 Pre Detection amp 50 Post Detection A 120 sec Approx 16 min A 48 seconds V 120 sec V 48 seconds A amp V 48 sec A amp V n a Custom 120 sec Summed 48 sec Full Page 8 5 x 11 Printouts v Electronic Calipers v v v Non Invasive Programmed Stimulation NIPS v v v PMT Counter A v A Longevity Estimate v v v Real Time Extended Markers v v v Summary Screen FastPath Summary Quick Look Quick Look II with Alerts with Alerts Previous Test Results v Other Weight Volume Victory XL DR EnRhythm P1501DR EnPulse E2DRO1 23 5 gm 11 cc 21 0 gm 13 cc 27 1 gm 12 1 cc Victory DR EnPulse E2DR21 18 gm 8 cc 23 6 gm 11 1 cc Longevity 100 pacing 60 ppm Victory XL DR EnRhythm P1501DR EnPulse E2DRO1 12 3 years w AC 10 5 years 7 9 years w CM AC amp CM Off A amp V 2 5 V 500 Q 11 0 years w o SEGMs off 7 5 years w o CM amp PW 0 4 ms AC On A 2 5 V V 1 V 500 Q amp PW 0 4 ms CM On A 2 5 V V 1 5 V 500 Q amp PW 0 4 ms
25. is automatically measured out of clinic There is a 24 cycle monitoring period before the device configures the hardware to begin measuring P R waves As long as the monitoring phase is completed without the detection of eight consecutive paced events or four occurrences of the sequence paced sensed paced the device will begin measuring the intrinsic P R wave signals What is the sequence of the AutoCapture pacing system follow up EGMs The five follow up EGMs are the last five pacing pulses from the last AutoCapture threshold test They usually consist of a test pulse at the amplitude prior to confirming loss of capture the two pulses that identified loss of capture voltage one step below the capture threshold and the two test pulses where the capture threshold is identified On occasion you will see three losses of capture and two test pulses when capture is regained If there is no intrinsic signal when the measurement timer expires the device will attempt a measurement one hour later Is there some time out on this process The P R wave measurements occur every 23 hours approximately with Measured Data Logging and Lead Impedance Monitoring These measurements have two phases stability monitoring and amplitude measurement If the device does not find a stable rhythm stability monitoring just repeats over and over again for the remaining portion of the 23 hours if needed until a stable rhythm is present If the a
26. lgorithm has entered the measurement phase however and the algorithm becomes inhibited the device will attempt a measurement one hour later This behavior may continue for the rest of the day or until a successful measurement has taken place If a measurement cannot be made before the next 23 hour clock expires the device records inhibit for that day When would the TI be displayed on the P R wave trend If the algorithm is inhibited for an entire week the inhibited I appears on the trend 18 How many complexes are needed to complete a P R wave measurement The measurement is always a median of five measured complexes It is possible but rare that we ll get fewer than five follow up EGM complexes This rare occasion can occur with some AF Suppression algorithm interactions Is the Automatic on the AutoCapture Weekly Trend the last programmed threshold data or the last loss of capture Ventricular AutoCapture automatic threshold measurements can be triggered by a multitude of things loss of capture magnet application or a normally scheduled threshold search What voltage and pulse width is the lead impedance monitoring conducted at The out of clinic lead impedance measurements are conducted at a minimum of 2 5 V or the programmed pulse amplitude if programmed higher Device conducted lead impedance measurements have no minimum pulse width limitation Does the programmed pulse wid
27. lse 5816 XL DR 1291 E2DR01 5810 DR 1290 E2DR21 Diagnostics and Follow up continued Stored IEGM Trigger Counter v v v Ventricular High Rate Episode Log Counter IEGM Counter IEGM Counter IEGM IEGM Trigger Options Patient Magnet A Tachy Detection High Atrial Rate High Atrial Rate A Tachy Response High Atrial Rate High Ventricular Rate V Tachy Detection AMS Entry Magnet AMS Exit Non sustained VT PMT Termination Sudden brady response PVCs 2 to 5 PMT Adv Hysteresis AT AF Detection High Ventricular Rate IEGM Storage Time Rolling or Frozen Rolling only Rolling or Frozen 50 Pre Detection amp 50 Post Detection A 120 sec Max 110 seconds A 48 seconds V 120 sec Pre post storage can be selected V 48 seconds A amp V 48 sec A amp V n a Custom 120 sec Summed 48 sec Full Page 8 5 x 11 Printouts v Electronic Calipers y v v Non Invasive Programmed Stimulation NIPS Jv A v PMT Counter v v v Longevity Estimate v v v Real Time Extended Markers v v v Summary Screen FastPath Summary System Summary Quick Look II with Alerts with Alerts Previous Test Results v Other Weight Volume Victory XL DR Insignia Ultra 1291 EnPulse E2DRO1 23 5 gm 11 cc 29 6 gm 12 6 cc 27 1 gm 12 1 cc Victory DR Insignia Ultra 1290 EnPulse E2DR21 18 gm 8 cc 25 4 gm 10 8 cc 23 6 gm 11 1 cc Longevity 100 pacing 60 ppm Victory XL DR Insignia Ultra 1291 EnPulse E2DRO1 AC amp CM Off
28. lts of the European AT500 verification study PACE April 2002 254 Part II abstract 538 657 Padeletti L Purerfellner H Adler S Waller T Harvey M Horvitz L Holbrook R Kempen K Mullen A Hettrick D Combined efficacy of atrial sepal lead placement and atrial pacing algorithms for the prevention of paroxysmal atrial tachyarrythmias J Cardiovasc Electrophysio 2003 14 11 37
29. mpact the device longevity 3 Rest Rate is controlled by the MV sensor Patients potentially depending on how often the algorithm updates may not be able to achieve the benefits of rest rate if they have a respiratory disease or heart failure 4 Dual sensors This feature may be difficult and time consuming to set up appropriately 16 Victory Device Questions and Answers What programmer will interrogate the Victory pacemaker The 3510 3510 programmer and in the near future the Merlin Patient Care System will interrogate the Victory device What programmer software is required to interrogate the Victory pacemaker The programmer software is 3307 version 5 0 or higher Does the Victory device have SEGMs Yes there are nine programmable triggers with 120 seconds of storage Do the follow up EGMs reduce the SEGM capacity No follow up EGMs are separate and do not affect the capacity of the device to store SEGMs Why don t the AT AF episode counts match the AMS counts With the introduction of the AT AF Diagnostics we introduced a separate algorithm to populate this diagnostics The purpose of this algorithm is to clarify true arrhythmias from signal drop out that most devices experience Prior to exiting an AT AF episode the device has a short 20 second reconfirmation period to verify the patient has truly returned to sinus rhythm Only after the device has confirmed sinus rhythm is
30. r every week that it is active The dual zone rate response may be difficult to program correctly Dual chamber SEGM collection is not available have to select either A or V Kappa had an evoked response undersensing issue which resulted in high output mode therefore Ventricular Capture Management has been modified in the EnPulse device Time will tell if the algorithm modification works and if the clinicians physicians will give it a try Auto sensing algorithms have proven superior to fixed sensing algorithms FALSE The comparison between fixed and variable sensitivity did not reveal any superiority over automatic adaptation Compared with the recommended 2 1 sensing safety margin the Auto Sensing feature performed equal to manual programming in preventing episodes of under oversensing and was better for atrial undersensing during sleep Size and Shape Victory DR Victory XL DR EnPulse Pacemakers 5810 5816 E2DR01 43 h x 44 1 x6 t 44x52x6 44 7 x47 9x7 5 Mass em z5 77 gm Volume e Ble Longevity years 6 2 years 11 0 years 7 5 years 2 5 V A amp V 500 Q 60 ppm 100 DDD pacing internal comparison Medtronic Medtronic AT500 Pacemaker Model AT501 Medtronic s position The world s first pacing system to offer unparalleled capabilities to monitor treat and help physicians effectively manage atrial arrhythmias Medtronic AT501 Pacemaker Key Featu
31. res Tachyarrhythmia Prevention Algorithms Atrial Preference Pacing Atrial Rate Stabilization Post Mode Switch Overdrive Pacing Atrial Pace Termination Therapy lt Non Competitive Atrial Pacing Miscellaneous Key Algorithms Auto Adjusting Sensitivity Thresholds Diagnostics lt AT AF Episode List Cardiac Compass Trends Quick Look Report lt VT Episode List lt Duration Histogram Report Medtronic AT501 Opportunities and Weaknesses The device has very limited bradycardia features no capture management rate drop response or sleep rate It is a very large device with poor longevity ATP isn t clinically proven Several studies AT500 Verification study 325 patients p lt 0 89 ATTEST 370 patients p lt 0 25 and ASPECT 288 patients demonstrated no significant difference in the mean number or frequency of AT episodes or AT burden when comparing ATP in the On group versus the Off group Atrial prevention algorithms may be pro arrhythmic The ATTEST study demonstrated an increase in AF Burden 71 of the patients had an increase in recurrent AT after the use of PMOP FDA labeling requires septal lead placement for the use of the atrial prevention algorithms It is indicated for atrial tachyarrhythmias only Size and Shape Victory DR Victory XL DR Medtronic Pacemakers 5810 5816 AT501 Dimensions mm 43 h x 44 1 x 6 t 44x52x6 44x59x7 5 Mass gm
32. results are displayed with follow up SEGMs for quick visual validation of the test results If the clinician chooses to perform additional tests during an in clinic visit we have added preset test values to facilitate prompt testing The addition of this time saving feature allows for more quality time with patients and less time maneuvering through the programmer screens The FastPath Summary Screen allows the clinician flexibility with multiple follow up options More Time Over the Life of the Device Features that potentially could extend longevity are Ventricular Intrinsic Preference Advanced Hysteresis Auto Rest Rate and the Ventricular AutoCapture algorithm They may also reduce cost and patient stress by reducing pacemaker replacements Victory Pacemaker Overview The Victory DR pacemaker incorporates the most advanced bradycardia management tools on the market into one small package that includes the following new features Ventricular Intrinsic Preference VIP technology a new refined AICS algorithm designed to reduce unnecessary ventricular pacing Device dictated intrinsic measurements both P and R waves and diagnostic trends Lead Monitoring and Auto Polarity Switch Ventricular Rate during AMS Histogram Separate programmable Max AF Suppression Rate Ventricular AutoCapture pacing system enhancements Pre set test values to speed in clinic testing Optimized shipped setting to speed implan
33. sing safety margin in an implanted pacemaker Autosensing Investigation Team PACE 1996 19 11 pt 2 1708 13 36 10 11 12 13 14 15 16 Pieragnoli P Colella A Moro E Orazi S Landolina M Vicentini A Maglia G Gulizia M Blended dual sensor does not give additional benefits to single sensor in DDDR pacemaker patients Results from the DUSUSLOG study Heart Rhythm 2005 2 1 S40 AB21 2 Shukla HH Flaker GC Hellkamp AS James EA Lee KL Goldman L Orav EJ Lamas GA Clinical and quality of life comparison of accelerometer piezoelectric crystal and blended sensor in DDDR paced patients with sinus node dysfunction in the mode selection trial MOST PACE 2005 28 8 762 70 Sweeney MO et al Randomized pilot study of a new atrial based minimal ventricular pacing mode in dual chamber implantable cardioverter defibrillators Heart Rhythm 2004 1 160 167 Lee MA Weachter R et al Can preventative and antitachycardia pacing reduce the frequency and burden of arial tachyarrhythmias The ATTEST Study Results PACE 2002 25 4 Part II Carlson M Ip J et al A new pacemaker algorithm for the treatment of atrial fibrillation results of the atrial dynamic overdrive pacing trial ADOPT A J Am Coll Cardio 2003 42 627 633 Huegl R Israel C Lawo T Unteger C Kennis I Warman E Lauer B Center Clinic Bad Berka Bad Berka Germany Does pace termination of atrial arrythmias influence time of recurrence Resu
34. t set up Follow up EGMs for intrinsic monitoring and ventricular AutoCapture pacing system Victory DR vs Insignia Ultra DR vs EnPulse DR Pacemaker Victory DR 5816 XL DR 5810 DR Feature or Therapy Insignia Ultra EnPulse 1291 E2DRO01 1290 E2DR21 Ventricular Intrinsic v Preference VIP technology Auto P and R Wave Measurements Trend Diagnostics and Follow up AV Search Hysteresis Search AV Lead Monitor and Trends Follow Up EGM V Response during v AMS Histogram Victory DR vs EnRhythm DR vs EnPulse DR Pacemaker Victory DR EnRhythm DR EnPulse Feature or Therapy 5816 XLDR P1501DR E2DRO01 5810 DR E2DR21 Ventricular Intrinsic v Managed Ventricular Search AV Preference VIP Pacing MVP technology Auto P and R Wave v v v Measurements Trend Diagnostics and Follow up Lead Monitor and Trends Follow Up EGM V Response during AMS Histogram Victory DR vs Philos II DR vs Symphony DR Pacemaker Victory DR 5816 XL DR 5810 DR Feature or Therapy Ventricular Intrinsic Preference VIP technology Philos II DR Symphony DR 341 826 2550 AV Hysteresis DDD AMC Mode Auto P and R Wave Measurements Trend Diagnostics and Follow up Lead Monitor and Trends Follow Up EGM V Response during AMS Histogram Competitive Overview Medtronic EnRhythm Pacemaker Model P1501DR Me
35. teresis v v v AutoIntrinsic Conduction Search v v Ventricular Intrinsic Preference VIP A Negative AV PV Hysteresis v v v Programmable Atrial Absolute Refractory Period v v Rate Adaptive AV PV Delay v v v PMT Intervention A v v PVC Response v v v Atrial Protection Interval v v Rate Adaptive Pacing Sensor Accelerometer Accelerometer Accelerometer Rate Responsive PVARP v v Far Field Protection A v Automatic Rate Adaptive Pacing v v v Sensor Passive v v v Sensor Behavior Prediction v v v Diagnostics and Follow up AF Suppression Histogram v v v AF Suppression Histogram Event Counts v v v AT AF Episodes Log Histogram A v Ventricular Capture Threshold Monitoring Long Term Long Term Weekly Threshold Threshold Record Threshold Record Trend Daily Intrinsic Measurement and Trend v Rate Histogram v v v Sensor Indicated Rate Histogram v v v Daily Lead Measurement and Trend v Mode Switch Histogram A v v Patient Triggered Stored EGM v v v AMS Log AT AF Episodes Log 32 episodes 16 frozen 16 FIFO time date duration and max A rate 16 episodes AMS time date duration max A rate AMS Only 32 episodes 16 frozen 16 FIFO time date duration and max A rate V Rate During AMS Histogram v 20 21 Identity ADx DR vs Identity DR vs Victory DR Device Feature or Therapy Identity ADx Identity Victory 5386 XL DR 5376 XL DR 5816 XL DR 5380 DR 5370 DR 5810 DR Diagnostics
36. th remain when an auto polarity switch occurs Yes an auto polarity switch has no effect on the pulse width value What inhibits a lead impedance measurement Both atrial and ventricular lead impedance measurements are inhibited if the rate is faster than 170 ppm In addition atrial lead impedance measurement is also inhibited if five PVCs occur Device Family DR SR Name Size DR SR DC VDR SC M S M S Victory Micro 0 55 Ah 5810 5610 XL 0 95 Ah 5826 Identity ADx Micro 0 55 Al 5480 XL 0 95 Ah Integrity ADx Micro 0 55 Al XL 0 95 Ah Verity ADx Micro 0 55 Al XL 0 95 Ah 5256 5456 i 5056 5357 5157 Identity Micro 0 55 Al XL 0 95 Ah 19 Identity ADx DR vs Identity DR vs Victory DR Device Feature or Therapy AF Prevention Therapy Identity ADx 5386 XL DR 5380 DR Clinically proven AF Suppression algorithm Identity 5376 XL DR 5370 DR Clinically proven AF Suppression algorithm Victory 5816 XLDR 5810 DR Clinically proven AF Suppression algorithm Beat by Beat Ventricular AutoCapture v v v Automatic Capture Threshold Search v v v Auto Mode Switch v v v AMS Base Rate v v v Auto Sleep Rest Mode Sensor controlled Sensor controlled Sensor controlled Rate Hysteresis with Programmable Search v v v Advanced Hys
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