St. Jude Medical for Medical Professionals

• High output option: Available in 36 J or 30 J output model options for patients with varying needs.
• AF Suppression™ algorithm: The only algorithm clinically proven to suppress symptomatic episodes of paroxysmal and persistent AF by promoting atrial-based pacing at patient-tailored rates. Studies show a 25% decrease in symptomatic AF burden.¹
• Unique SJM® patient notifier: Promote CRT-D RF devices use vibration to notify the patient of critical system changes, i.e. low battery. The intent is to help patients with hearing difficulties receive the critical notification, as well as to avoid false alarms due to confusion with environmental noises.
• Automatic Daily High Voltage Lead Integrity Test: This device provides a painless daily high-voltage lead integrity check, featuring a low-voltage output pulse measured from several angles or vectors in the body. Lead impedance values can be safely and reliably checked painlessly. Data are reported in a trending chart to alert the physician about sudden or pronounced changes in lead impedance.

Biventricular Pacing

VectSelect™ programmable LV pulse configuration (LV ring-RV coil, LV tip - RV coil or LV bipolar): May be adjusted noninvasively via the programmer.

Independently programmable RV and LV amplitude and pulse widths: Accommodates patients with different energy demands for each chamber, aiding in efficient maintenance of capture.

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.

Independent RV and LV threshold testing during follow-up: Enables verification of each lead independently to determine each chamber's pacing threshold and program the outputs for consistent capture and battery longevity.

DeFT Response®  technology: Many drugs have been shown to raise defibrillation thresholds (DFTs) to potentially unsafe levels.^2-4 Unique DeFT Response technology tools provide more clinically proven, noninvasive options for managing high DFTs.

SenseAbility® technology: SenseAbility feature with Decay Delay and Threshold Start provides the flexibility to fine-tune sensing to individual patient needs and help eliminate the over-sensing of T waves, far-field R waves, fractionated QRS complexes, and other extraneous signals.

InvisiLink™ wireless telemetry: These devices feature wireless telemetry, which opens the door to passive remote patient monitoring and offers the following:

• Range sufficient for use during implant programming as well as followup.
• "Invisible" link to patients for remote monitoring.
• Minimal impact to device longevity in normal use.

QuickOpt® timing cycle optimization: Provides quick and effective optimization for more patients at the push of a button.⁵

• IEGM-based AV and V-V optimization allows optimized timing without the need for echo-guided optimization.
• V-V timing optimization may help improve patient outcomes. Programmable timing of the right and left ventricular outputs helps to ensure appropriate therapy and may reduce the number of nonresponders ⁶ because not all patients respond to simultaneous biventricular pacing.

DC Fibber™ induction: Exclusive DC Fibber VF induction has a documented 95.5% success rate for inducing fibrillation on the first induction as compared to a 72.7% success rate for Shock-on-T.⁷

¹ 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). J Am Coll Cardiol 2003; 42:627-33.

² Crystal E, Ovsyshcher Eli et al. Mexiletine related chronic defibrillation threshold elevation: case report and review of the literature. PACE 2002; 25 (Part I):507-508.

³ McBride B, Clyne C et al. Does the use of beta-blocker or choice of beta-blocker impact the defibrillation threshold? Circulation 2004; Supplement III, 110 (17):III-625, 2907.

⁴ Nielsen T, Hamdan M et al. Effect of acute amiodarone loading on energy requirements for biphasic ventricular defibrillation. American Journal of Cardiology; 88:446-448.

⁵ 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 dual-chamber ICD implants. Journal of Cardiovascular Electrophysiology 2007; 18: 185-191.

⁶ 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. J Cardiac Failure 2004; 10:4 (supplement): 572 (abstract 199).

⁷ Sharma AD, O'Neill PG, Fain E et al. Shock on T versus DC for induction of ventricular fibrillation: a randomized perspective comparison. 21st Annual Scientific Session North American Society of Pacing & Electrophysiology (NASPE). Poster presentation published in meeting proceedings. Washington, DC USA. May 2000.

Indications & Usage

The Current™ and 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 (as defined in the clinical trials section included in the Merlin 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 III 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 & 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 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 used, 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. Patients should be directed to avoid devices which generate a strong electric or magnetic interference (EMI). EMI could cause device malfunction or damage, resulting in nondetection or delivery of unneeded therapy. Moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation.

Device Modification: 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 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.

Electromagnetic Interference

Instruct patients to avoid devices which generate a strong electric or magnetic interference (EMI). EMI could cause device malfunction or damage, resulting in non-detection or delivery of unneeded therapy. Moving away from the source or turning it off will usually allow the pulse generator to return to its normal mode of operation.

Electrosurgical cautery: Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause device malfunction or damage. If electrocautery is necessary, keep the current path and groundplate as far away from the pulse generator and leads as possible.

External defibrillation. External defibrillation may damage the pulse generator or may result in temporary and/or permanent myocardial damage at the electrode-tissue interface as well as temporarily or permanently elevated pacing capture thresholds. Minimize current flowing through the pulse generator and lead system by following these precautions when using external defibrillation on a patient with a pulse generator:

• Position defibrillation paddles as far from the pulse generator as possible (minimum of 5 inches [13 cm])
• Use the lowest clinically appropriate energy output
• Confirm pulse generator function following any external defibrillation.

High radiation sources: Do not direct high radiation sources such as cobalt 60 or gamma radiation at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage and confirm its function after treatment.

Lithotripsy: Lithotripsy may permanently damage the pulse generator. Avoid it unless the therapy site is not near the pulse generator and leads.

Diathermy: Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or may permanently damage the pulse generator.

Magnetic resonance imaging (MRI): MRI for patients with implantable pulse generators has been contraindicated by MRI manufacturers. Clinicians should carefully weigh the decision to use MRI with ICD/CRT-D patients. MRI may cause device malfunction or injury to the patient.

Ultrasound therapy: Diagnostic and therapeutic ultrasound treatment is not known to affect the function of the pulse generator.

Transcutaneous Electrical Nerve Stimulation (TENS): TENS may interfere with device function. To reduce interference, place the TENS electrodes close to one another and as far from the device/lead system as possible. Monitor cardiac activity during TENS use.

Radiofrequency ablation: Radiofrequency (RF) ablation in a patient with a pulse generator may cause device malfunction or damage. Minimize RF ablation risks by:

• Programming the device to Defib Off and Pacer Off
• Avoiding direct contact between the ablation catheter and the implanted lead or pulse generator
• Positioning the groundplate so that the current pathway does not pass near the pulse generator system, i.e., place the groundplate under the patient’s buttocks or legs
• Having external defibrillation equipment available.

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, thromboemboli, 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 that shocking capability may be lost,imagined shocking (phantom shock).

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Please see the physician’s manual for appropriate devices for indications, contraindications, warnings, precautions and potential adverse events.

 Complete Arrhythmia Management Brochure

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 Delivering Complete Arrhythmia Management Presentation

Promote RF CRT-D

• 3213-36 (36 J)
• 3213-30 (30 J)
• InvisiLink Wireless Telemetry
• VectSelect LV Pace Configuration
• QuickOpt Timing Cycle Optimization
• AF Suppression Pacing
• Exercise Trending

Promote RF CRT-D Spec Sheet