Promote® Plus - Sante International SA
Contents
1. 10 22 Stored Electrograms Therapy Summary Episodes Summary Lifetime Diagnostics AT AF Burden Trend Ventricular HV Lead Impedance Trend Histograms PMT Data Real Time Measurements RTM LV first with 10 ms interventricular delay Up to 45 minutes including up to one minute programmable pre trigger data per VT VF diagnosis detection electrograms triggers include diagnosis therapy atrial episode PMT termination PC shock delivery noise reversion magnet reversion and morphology template verification Diagram of therapies delivered Directory listing of up to 60 episodes with access to more details including stored electrograms History of bradycardia events and device initiated charging Trend data and counts Multi Vector Trend Data Event Histogram AV Interval Histogram Mode Switch Duration Histogram Peak Filtered Rate Histogram Atrial Heart Rate Histogram Ventricular Heart Rate Histogram AT AF Burden Exercise and Activity Trending V Rates During AMS Information regarding PMT detections Pacing lead impedances high voltage lead impedances unloaded battery voltage and signal amplitudes 1 Matthew T Bennett et al The ICD alert is potentially an unreliable ICD warning feature Canadian Cardiovascular Congress 2 Baker et al Acute evaluation of programmer guided AV PV and VV delay optimization comparing an IEGM method and echocardiogram for cardiac resynchronization therapy in heart failure patients and d2. which can provide insight into disease state progression Up to 45 minutes of continuous fully annotated stored electrograms including up to 60 seconds of pre trigger information per electrogram e Preferential EGM storage capability allows prioritization of episode storage InvisiLink wireless telemetry in conjunction with the Merlin home transmitter and Merlin net PCN allows for seamless remote monitoring and follow up InvisiLink RF telemetry uses a dedicated range of frequencies designated for medical devices called the MICS Medical Implant Communications Service frequency band which helps reduce the interference seen on frequencies used by common household electronics DC Fibber Induction has a documented 95 5 success rate for inducing fibrillation on the first induction Indications and Usage The Promote pulse generators are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias AF Suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction In patients indicated for an ICD the Promote pulse generators are also intended to provide a reduction of the symptoms of moderate to severe heart failure NYHA Functional Class III or IV in those patients who remain symptomatic despite stable optimal medical therapy
3. and help eliminate oversensing of T waves fractionated QRS complexes and other extraneous signals without compromising refractory periods or sensitivity settings Exclusive AF Suppression algorithm is clinically proven to suppress episodes of paroxysmal and persistent AF Studies show a 25 decrease in symptomatic AF burden oh ap ok s r n G8 w s t oy m r i OS mv 5 1 m PROMOTE Wieder 3211 36 High Votoge Con ED DODRV Sr JUDE MEDICAL SYLMAR CAUSA AT AF Alerts notify patients and their clinics when a programmed AT AF threshold or continuous episode duration has been exceeded or when a high ventricular rate accompanies the AT AF episode Automatic Daily High Voltage Lead Integrity Test is designed to ensure optimal patient safety Morphology Discrimination plus AV Rate Branch SVT discrimination feature helps reduce the risk of inappropriate ICD shocks and is intended to promote fast accurate diagnosis and delivery of therapy Clinical data states that this combination resulted in a sensitivity of 100 with a specificity of 85 Programming ATP schemes per zone may increase the success of ATP prior to requiring a shock Exercise Trend diagnostic assists clinicians in determining the level of exercise in which a patient may be engaged Combining sensor data with heart rate information this feature allows clinicians to see what heart rates are achieved during patient activity
4. the number of non responders Active during auto mode switch triggered pacing with BiV Trigger Mode helps maintain a high percentage of BiV pacing by triggering pacing in both the left and right ventricles in response to a sensed ventricular event e VectSelect programmable LV pulse configuration LV ring RV coil LV tip RV coil or LV bipolar may be adjusted noninvasively via the programmer e Negative AV hysteresis with search promotes ventricular pacing by automatically reducing the AV delay when intrinsic activity is present thereby promoting a high degree of ventricular pacing e DeFT Response Technology allows more non invasive programming flexibility in the management of DFTs to ensure adequate safety margins with unsurpassed energy delivery Programmable pulse widths allow the user to tailor the shock to the individual patient making shocks more efficacious SVC shocking electrode can be quickly and noninvasively activated or deactivated with the press of a button 36 J delivered energy provides unsurpassed energy for defibrillation Four programmable tilt options are available to accommodate variances among patients Together these features can help to reduce risk by managing unpredictably high DFTs and providing adequate defibrillation safety margins The SenseAbility feature with Decay Delay and Threshold Start provides the flexibility to fine tune sensing to individual patient needs
5. Programmable Rate and Delay Parameters Auto Mode Switch AMS Atrial Tachycardia Detection Rate ppm AMS Base Rate Auto PMT Detection Termination St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar CA 91342 USA 1 818 362 6822 1 818 364 5814 Fax sjm com CAUTION FEDERAL LAW USA RESTRICTS THIS DEVICE TO SALE DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN Consult the User s Manual for information on indications contraindications warnings and precautions Unless otherwise noted Off DDD R DDT R Off DDD R DDT R AAT R On Off Passive Off Base Rate ppm Rest Rate ppm Maximum Tracking Rate ppm Maximum Sensor Rate ppm Paced AV Delay ms Sensed AV Delay ms Rate Responsive AV Delay Pulse Amplitude Atrial RV and LV V Pulse Width Atrial RV and LV ms Hysteresis Rate ppm Rate Hysteresis with Search Off DDI R DDT R VVI R VVT R 110 300 40 45 135 Atrial Pace Off Passive DI R VVT R VVI R AAI R DOO R VOO R AOO R D DDI R VVT R VVI R AAI R AAT DOO VOO A00 St Jude Medical Sweden AB Veddestavagen 19 175 84 Jarfalla Sweden 46 8 474 4000 46 8 760 9542 Fax St Jude Medical Europe Inc The Corporate Village Figueras Building Avenue Da Vinci laan 11 Box F1 B 1935 Zaventem Belgium 32 2774 6811 32 2 772 8384 Fax or indicates that the name is a trademark of or licen
6. Promote Plus Cardiac Resynchronization Therapy Defibrillators CRT Ds with DF 1 and SJ4 Connectors MODELS CD3211 36 and CD3211 36Q SPECIFICATIONS The SJ4 connector is designed to simplify implants by streamlining defibrillation connections into a single terminal pin and reducing the number of set screws The SJ4 connection reduces pocket bulk which may provide increased comfort particularly for patients who are thin or small in stature and could lessen the risk of lead to can abrasion a known complication Triple Redundancy Safety Platform is designed to minimize risk and increase security and patient comfort through multiple hardware and software system safeguards Vibratory Patient Notifier clinically proven to be superior to auditory notifiers enables patients with hearing problems to be alerted to a low battery lead related complications and more Jailoredvherapy features designed to customize treatment to each patient s unique needs e QuickOpt Timing Cycle Optimization provides quick and effective optimization for more patients at the push of a button IEGM based AV and V V optimization allows optimized timing without need for echo guided optimization V V timing optimization may help improve patient outcomes Because not all patients respond to simultaneous biventricular pacing programmable timing of right and left ventricular outputs helps to ensure appropriate therapy and may reduce
7. as defined in the clinical trials section included in the Merlin Patient Care System PCS on screen help and have a left ventricular ejection fraction less than or equal to 35 and a prolonged QRS duration to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic permanent atrial fibrillation and have NYHA Class II or Ill heart failure Contraindications Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity electrolyte imbalance or acute myocardial infarction Warnings and Precautions Resuscitation Availability Do not perform device testing unless an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation CPR are readily available Lead system Do not use another manufacturer s lead system without demonstrated compatibility as undersensing cardiac activity and failure to deliver necessary therapy may result Avoiding shock during handling Disable tachyarrhythmia therapy Enable Disable Tachy Therapy or program tachyarrhythmia therapies Off during surgical implant and explant or post mortem procedures as well as when disconnecting leads as the device can deliver a serious shock if you touch the defibrillation terminals while the device is charged Additional pacemaker implanted These devices provide bradycardia pacing If another pacemaker is u
8. mboemboli venous occlusion venous or cardiac perforation Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT D system that may include the following dependency depression fear of premature battery depletion fear of shocking while conscious fear of losing shock capability imagined shocking phantom shock Refer to the User s Manual for detailed indications contraindications warnings precautions and potential adverse events Ean TEM ST JUDE MEDICAL MORE CONTROL LESS RISK PHYSICAL SPECIFICATIONS Models Telemetry Delivered Energy Volume cc Weight g Size mm Defibrillation Lead Connections Sense Pace Lead Connections High Voltage Can D3211 36 CD3211 360 RF RF 36 365 43 42 82 82 81x 50x14 75x50x 14 DF 1 SJ4 IS 1 IS 1 Electrically active titanium can Electrically active titanium can PARAMETER SETTINGS V Triggering BiV Trigger Mode QuickOpt Timing Cycle Optimization Ventricular Pacing Interventricular Pace Delay ms Ventricular Sensing Ventricular Pacing Chamber Negative AV Hysteresis Search ms Rate Responsive AV Delay VectSelect LV Pulse Configuration On Off Sensed paced AV delay Interventricular Pace delay Simultaneous RV First LV First RV Only RV First 10 80 LV First 15 80 in increments of 5 RV only not programmable RV only biventricular Off 10 20 30 40 Off L
9. ow Medium High LV tip to RV coil LV bipolar LV ring to RV coil AF Management AF Suppression Pacing On Off No of Overdrive Pacing Cycles 15 40 in steps of 5 Maximum AF Suppression Rate 80 150 ppm Sensing Detection SenseAbility Technology Threshold Start Decay Delay Ventricular Sense Refractory ms Detection Zones SVT Discriminators Reconfirmation Antitachycardia Pacing Therapy Automatic Sensitivity Control adjustment for atrial and ventricular events Post Sensed Atrial 50 62 5 75 100 Post Paced Atrial 0 2 3 0 mV Post Sensed Ventricular 50 62 5 75 100 Post Paced Ventricular Auto 0 2 3 0 mV Post Sense Post Pace Atrial Ventricular 0 220 Post Pace Ventricular Auto 125 157 VT 1 VT 2 VF AV Rate Branch Sudden Onset Interval Stability Morphology Discrimination MD with Manual or Automatic Template Update Continuous sensing during charging ATP Configurations Burst Cycle Length Min Burst Cycle Length ms Number of Bursts Stimuli Add Stimuli per Burst High Voltage Therapy Ramp Burst Scan 1 or 2 schemes per zone Readaptive or Fixed 150 400 in increments of 5 1 15 with 2 20 Stimuli On Off High Voltage Output Mode Waveform RV Polarity Electrode Configuration Bradycardia Pacing Fixed Pulse Width Fixed Tilt Biphasic Monophasic Cathode Anode RV to Can RV to SVC Can Permanent Modes Temporary Modes Rate Adaptive Sensor
10. sed it should have a bipolar pacing reset mode and be programmed for bipolar pacing to minimize the possibility of the output pulses being detected by the device Modifying the device This device has been tested for compliance to FCC regulations Changes or modifications of any kind not expressly approved by St Jude Medical Inc could void the user s authority to operate this device Suboptimal radio frequency RF communication The Merlin PCS indicates the quality of the RF communication by the telemetry strength indicator LEDs on both the Merlin PCS and the Merlin Antenna Please see the User s Manual for a list of potential causes to suboptimal radio communication Potential Adverse Events Possible adverse events in alphabetical order associated with the system include but are not limited to the following acceleration of arrhythmias caused by device air embolism allergic reaction bleeding cardiac tamponade chronic nerve damage death erosion exacerbation of heart failure excessive fibrotic tissue growth extracardiac stimulation phrenic nerve diaphragm chest wall extrusion fluid accumulation formation of hematomas or cysts inappropriate shocks infection keloid formation lead abrasion and discontinuity lead migration dislodgment myocardial damage pneumothorax shunting current or insulating myocardium during defibrillation with internal or external paddles potential mortality due to inability to defibrillate or pace thro
11. sed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL the nine squares symbol and MORE CONTROL LESS RISK are trademarks and service marks of St Jude Medical Inc and its related companies 2009 St Jude Medical Inc All Rights Reserved Item No G0218 Rate Responsive PVARP VREF Off Low Medium High Ventricular Intrinsic Preference VIP Off 50 200 50 150 in increments of 25 160 200 in increments of 10 Post Therapy Pacing Independently programmable from Bradycardia and ATP Post Shock Pacing Mode Post Shock Base Rate ppm Post Shock Pacing Duration min Device Testing Induction Methods Off AAI VVI DDI or DDD 30 100 in increments of 5 Off 0 5 1 2 5 5 7 5 or 10 DC Fibber Pulse Duration sec Burst Fibber Cycle Length ms Noninvasive Programmed Stimulation NIPS Patient Notifiers 0 5 5 0 20 100 2 25 stimuli with up to three extrastimuli Programmable Notifiers On Off Device Parameter Reset Entry into Backup VVI Mode Vibration Duration sec Number of Vibrations per Notification Number of Notifications Time Between Notifications hours Electrograms and Diagnostics Device at ERI Charge Time Limit Reached Possible HV Circuit Damage Atrial Lead Impedance Out of Range Right Ventricular Lead Impedance Out of Range AT AF Burden Backup VVI HV Lead Impedance Out of Range LV Lead Impedance Out of Range On On 2 4 6 8 10 12 14 16 2 1 16
12. ual chamber ICD implants Journal of Cardiovascular Electrophysiology Vol 8 No 2 Feb 2007 3 Chan et al Tissue Doppler guided optimization of A V and V V delay of biventricular pacemaker improves response to cardiac resynchronization therapy in heart failure patients supplement 572 abstract 199 Cardiac Failure 2004 10 4 4 Mouchawar G Kroll M Val Mejias JE et al ICD waveform optimization a randomized prospective pair sampled multicenter study PACE 2000 23 Part Il 1992 1995 5 Carlson MD et al A new pacemaker algorithm for the treatment of atrial tial ADOPT JACC 2003 42 627 633 Overdrive Pacing ibrillation results of the Atrial Dynamic 6 Sperzel J Meine M et al A new automatic update function of the morphology template used for SVT VT discrimination in an ICD Europace Supplements Vol 3 July 2002 A 131 1515 7 Sharma AD O Neill PG Fain E et al Shock on T versus DC for induction o ventricular fibrillation a randomized prospective comparison 21st Annual Scientific Session North American Society of Pacing and Electrophysiology NASPE Poster presentation published in meeting proceedings Washington D C U S A May 2000 St Jude Medical World Headquarters One Lillehei Plaza St Paul MN 55117 USA 1 651 483 2000 1 651 482 8318 Fax aaa HSH aa ST JUDE MEDICAL MORE CONTROL LESS RISK
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