Product Highlights - Pacemaker

• The Endurity™ Core pacemaker allows patients to undergo MRI scans:
• In patients who have the Tendril™ 2088TC or IsoFlex™ Optim™ 1944/1948 leads, the MRI-ready device:
• – Allows MRI scans*
• – Permits a maximum whole body averaged specific absorption rate (SAR) of 2 Watts per kilogram (W/kg)
• Physician preferred size and physiologic shape minimize pocket size 
• Outstanding longevity provides 14,4 years of service life,1 which is supported by a 5-year warranty2 
• AutoCapture™ pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat-by-Beat™ capture confirmation. The AutoCapture pacing system automatically delivers a 5,0 V backup safety pulse when noncapture is detected, and it may be programmed to either a bipolar or unipolar configuration 
• Real-time electrogram (EGM) waveform, as well as the associated event markers that precede and follow a specific triggering event, can be programmed to automatically record up to 2 minutes of stored EGMs when encountering one or more programmable trigger options 
• An optional, easy-to-use hand-held device (SJM MRI Activator™ device) can be used to program the device to pre-approved MRI settings pre- and post-MRI scan, decreasing the number of workflow steps and increasing clinic efficiency 
• 6-month ERI-EOL interval

Indications: Implantation is indicated in one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block or sinus arrest, chronic atrial fibrillation, severe physical disability. Contraindications: Single-chamber pulse generators are contraindicated in patients with an implanted cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have demonstrated compromise of AV conduction. For specific contraindications associated with individual modes, refer to the programmer’s on-screen help.
Potential Adverse Events: The following are potential complications associated with the use of any pacing system: arrhythmia, heart block, thrombosis, threshold elevation, valve damage, pneumothorax, myopotential sensing, vessel damage, air embolism, body rejection phenomena, cardiac tamponade or perforation, formation of fibrotic tissue/local tissue reaction, inability to interrogate or program a device because of programmer malfunction, infection, interruption of desired device function due to electrical interference, loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface, or lead malfunction (fracture or damage to insulation), loss of normal device function due to battery failure or component malfunction, device migration, pocket erosion, or hematoma, pectoral muscle stimulation, phrenic nerve or diaphragmatic stimulation. The following, in addition to the above, are potential complications associated with the use of rate-modulated pacing systems: inappropriate, rapid pacing rates due to sensor failure or to the detection of signals other than patient activity, loss of activity-response due to sensor failure, palpitations with high-rate pacing. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.