Pacemakers

Endurity™ Core
Dual-Chamber Pacemaker

Product Highlights - Pacemaker

The Endurity™ Core pacemaker allows patients to undergo MRI scans*
n  hen combined with the Tendril™ 2088TC or IsoFlex™ Optim™ 1944/1948 leads,
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the MRI-ready device:
– Allows MRI scans*
– Permits a maximum whole body averaged specific absorption rate (SAR) of 2 Watts per kilogram (W/kg)
n Physician preferred size and physiologic shape minimize pocket size
n Outstanding longevity provides 9,7 years of service life,10 which is supported by an 5-year warranty11
n  utoCapture™ pacing system offers the maximum in threshold adaptability and patient safety with ventricular Beat-by-Beat™
A
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
n  tate-of-the-art features – Ventricular Intrinsic Preference (VIP™) technology, and the AF Suppression™ algorithm, are designed
S
to deliver optimal therapy for patients at implant and throughout their lives
n  he only pacemaker with programmable AT/AF alerts specifically indicated for detecting atrial tachyarrhythmias, which have been
T
found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF12
n  eal-time electrogram (EGM) waveform, as well as the associated event markers that precede and follow a specific triggering
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event, can be programmed to automatically record up to 2 minutes of stored EGMs when encountering one or more
programmable trigger options
n  n optional, easy-to-use hand-held device (SJM MRI Activator™ device) can be used to program the device to pre-approved MRI
A
settings pre- and post-MRI scan, decreasing the number of workflow steps and increasing clinic efficiency
n 6 -month ERI-EOL interval
*See MRI Conditional Parameters

Ordering Information - MRI-Ready Pacing System

Model Number Description Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM2152 Endurity Core Pacemaker 46 x 50 x 6
™
19 10,4 (± 0,5) IS-1

Min.
Model Number Description Insulation Fixation Introducer (F) Connector Length (cm)
2088TC Tendril STS Pacing Leads
™
Optim ™
Ext/Ret helix 6 IS-1 bipolar 46, 52, 58
1944 (J-shaped) IsoFlex™ Optim™ Pacing Leads Optim™ Tines 7 IS-1 bipolar 46,52
1948 (Straight) IsoFlex Optim Pacing Leads Optim ™
Tines 7 IS-1 bipolar 52, 58

DRAFT SPECIFICATIONS; CE MARK PENDING

Indications: Implantation is indicated in one or more of the following permanent conditions: syncope, Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated
presyncope, fatigue, disorientation due to arrhythmia/bradycardia or any combination of those symptoms. pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would onset of ventricular pacing. Single-Chamber Atrial Pacing is relatively contraindicated in patients who have
benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing is indicated demonstrated compromise of AV conduction.
for those patients exhibiting: sick sinus syndrome, chronic, symptomatic second- and third-degree AV
block, recurrent Adams-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia Potential Adverse Events: The following are potential complications associated with the use of any pacing
and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction system: arrhythmia, heart block, thrombosis, threshold elevation, valve damage, pneumothorax, myopotential
and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients sensing, vessel damage, air embolism, body rejection phenomena, cardiac tamponade or perforation,
with significant bradycardia and normal sinus rhythm with only rare episodes of A-V block or sinus arrest, formation of fibrotic tissue/local tissue reaction, inability to interrogate or program a device because of
chronic atrial fibrillation, severe physical disability. AF Suppression algorithm is indicated for suppression programmer malfunction, infection, interruption of desired device function due to electrical interference,
of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface or
indications. 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
Contraindications: Dual-chamber pulse generators are contraindicated in patients with an implanted nerve or diaphragmatic stimulation. The following, in addition to the above, are potential complications
cardioverter-defibrillator. Rate-Adaptive Pacing may be inappropriate for patients who experience angina associated with the use of rate-modulated pacing systems: inappropriate, rapid pacing rates due to sensor
or other symptoms of myocardial dysfunction at higher sensor-driven rates. An appropriate Maximum Sensor failure or to the detection of signals other than patient activity, loss of activity-response due to sensor failure,
Rate should be selected based on assessment of the highest stimulation rate tolerated by the patient. palpitations with high-rate pacing.
AF Suppression stimulation is not recommended in patients who cannot tolerate high atrial-rate stimulation.
Dual-Chamber Pacing, though not contraindicated for patients with chronic atrial flutter, chronic atrial Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential
fibrillation or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. adverse events.
 Pacemakers

Endurity™ Core
Dual-Chamber Pacemaker

Product Specifications - Pacemaker

PHYSICAL SPECIFICATIONS Stored Electrograms
Model PM2152 Options
Telemetry Inductive Priority Options Off; Low; High
Dimensions (mm) 46 x 50 x 6 Channel 1; 2; 3
Weight (g) 19 Triggers
Volume (cc) 10,41 Advanced Hysteresis Off; Low; High
Connector IS-1 AMS Entry/AMS Exit/
AMS Entry and Exit Off; Low; High
AT/AF Detection Off; Low; High
PARAMETER SETTINGS Magnet Response Off; Low; High
High Atrial Rate Off; Low; High
Rate/Timing Rate (min-1) 125-300 in steps of 25
No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Atrial Pace Refractory (ms) 190-400 in steps of 30; 440; 4702 High Ventricular Rate Off; Low; High
Atrial Sense Refractory (ms) 93; 125; 157; 190-400 in steps of 30; 440; 4702 Rate (min-1) 125-300 in steps of 25
Paced AV Delay (ms) 25; 30-200 in steps of 10; 225-300 in steps of 25; 350 No. of Consecutive Cycles 2; 3; 4; 5; 10; 15; 20
Base Rate (min-1) 30-130 in steps of 5; 140-170 in steps of 10 PMT Termination Off; Low; High
Far-Field Protection Interval (ms) 163 Consecutive PVCs Off; Low; High
Hysteresis Rate (min-1) Off; 30 4-150 in steps of 5 No. of Consecutive PVCs 2; 3; 4; 5
Search Interval (min) Off; 1; 5; 10; 15; 30 Noise Reversion Off; Low; High
Cycle Count 1-16 in steps of 1
Intervention Rate (min-1) Off; Same as Base Rate; 80-120 in steps of 10; Intrinsic +0; Other
Intrinsic +10; Intrinsic +20; Intrinsic +30
Intervention Duration (min) 1-10 in 1 minute intervals A and V Lead Monitoring Monitor; Auto Polarity Switch
Recovery Time Fast; Medium; Slow; Very Slow A and V Low Impedance Limit (Ω) 100-500 in steps of 25
Maximum Tracking Rate (min-1) 90-130 in steps of 5; 140-180 in steps of 10 A and V High Impedance Limit (Ω) 750-2500 in steps of 250; 3000
Mode AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); Lead Type Uncoded; Unipolar; Bipolar
VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); Magnet Response Off; Battery Test
DDD(R); Pacing Off Negative AV Hysteresis Search (ms) Off; -10 to -120 in steps of 10
Post Ventricular Atrial Blanking (ms) 60-200 in steps of 10; 225; 250 NIPS Options
PVARP (ms) 125-500 in steps of 25 Stimulation Chamber Atrial; Ventricular
Sensed AV Delay (ms) 25; 30-200 in steps of 10; 225-325 in steps of 25 Coupling Interval (ms) 100-800 in steps of 108
Rest Rate (min-1) Off; 30-150 in steps of 5 S1 Count 2-25 in steps of 1
Rate Responsive AV Delay Off; Low; Medium; High S19; S2; S3 and S4 Cycle (ms) Off; 100-800 in steps of 10 (Fixed or Adaptive)
Rate Responsive PVARP/VREF Off; Low; Medium; High Ventricular Support Rate (min-1) Off; 30-95 in steps of 5
Shortest AV Delay (ms) 25-50 in steps of 5; 60-120 in steps of 10 Sinus Node Recovery Delay (sec) 1; 2; 3; 4; 5
Shortest PVARP/VREF (ms) 125-475 in steps of 25 PMT Options Off; Passive; Atrial Pace2
Ventricular Blanking (ms) Auto, 12-52 in steps of 4 PMT Detection Rate (min-1) 90-180 in steps of 5
Ventricular Pace/Sense Refractory5 PVC Response Off; Atrial Pace2
(Fixed) (ms) 125; 160-400 in steps of 30; 440; 470; 500 2 Ventricular Intrinsic
Preference, VIP™ (ms) Off, 50-150 in steps of 25; 160-200 in steps of 10
Output/Sensing VIP Search Interval 30 sec.; 1; 3; 5; 10; 30 min.
VIP Search Cycles 1; 2; 3
A or V Pulse Amplitude (V) 0,25-4,0 in steps of 0,25; 4,5-7,5 in steps of 0,5 Ventricular Safety Standby Off; On
A or V Pulse Width (ms) 0,05; 0,1-1,5 in steps of 0,1 Diagnostic Trends AT/AF Activity; Lead Impedance; P and R Wave; V Threshold
A or V Pulse Configuration Unipolar (tip-case); Bipolar (tip-ring)
A or V Sense Configuration Unipolar Tip (tip-case); Bipolar (tip-ring); MRI Settings
Unipolar Ring (ring-case)
Ventricular AutoCapture™ MRI Mode AOO; VOO; DOO; Pacing Off
Pacing System On; Off MRI Base Rate 30-120 bpm in steps of 5 bpm
Primary Pulse Configuration Unipolar; Bipolar MRI Paced AV Delay 25 ms; 30-120 ms in steps of 10 ms
Backup Pulse Configuration Unipolar; Bipolar MRI Atrial Pulse Configuration Bipolar
Backup Pulse Amplitude (V) 5,03 MRI Atrial Pulse Amplitude 5,0 V; 7,5 V
Search Interval (hours) 8; 24 MRI Atrial Pulse Width 1,0 ms
AutoCapture MRI RV Pulse Configuration Bipolar
Paced/Sensed AV Delay (ms) 50/25; 100/70; 120/100 MRI RV Pulse Amplitude 5,0 V; 7,5 V
Atrial Sensitivity (mV) 0,1-0,46 in steps of 0,1; 0,5; 0,75-2,0 in steps of 0,25; MRI RV Pulse Width 1,0 ms
2,5-4,0 in steps of 0,5; 5,07
Ventricular Sensitivity (mV) 0,5-5,0 in steps of 0,5; 6-10 in steps of 1,0; 12,57 MRI Scan Exclusions
Rate-Modulated Parameters Lead Lead Lengths Scan Exclusion Zone
Tendril 2088TC Lead 46, 52, 58 cm Isocenter must be inferior to L4 or 10 cm superior to C1
Maximum Sensor Rate (min-1) 80-150 in steps of 5; 160-180 in steps of 10 IsoFlex 1944 Lead 46, 52 cm Isocenter must be inferior to L4 or superior to C1
Reaction Time Very Fast; Fast; Medium; Slow IsoFlex 1948 Lead 52, 58 cm Isocenter must be inferior to L4 or superior to C1
Recovery Time Fast; Medium; Slow; Very Slow
Sensor On; Off; Passive MRI Scan Parameters
Slope Auto (-1); Auto (+0); Auto (+1); Auto (+2); Original
Auto (+3); 1-16 in steps of 1 Lead Lead Lengths Magnet Full-Body
SAR SAR

4 2 2
SAR SAR
Threshold Auto (-0,5); Auto (+0,0); Auto (+0,5); Auto (+1,0); Tendril 2088TC Lead 46, 52, 58 cm 1.5T ≤ 2 W/kg
Auto (+1,5); Auto (+2,0); 1-7 in steps of 0,5 IsoFlex 1944 Lead 46, 52 cm 1.5T 1.5T ≤ 2 W/kg
AF Management 1.5T 1.5T
IsoFlex 1948 Lead 52, 58 cm 1.5T ≤ 2 W/kg
AF Suppression™ Algorithm Off; On
Lower Rate Overdrive (min-1) 103 1. ± 0,5 cc
Upper Rate Overdrive (min-1) 53 2. Programming options dependent on pacing mode.
No. of Overdrive Pacing Cycles 15-40 in steps of 5 3. This parameter is not programmable.
Rate Recovery (ms) 8; 123 90%
4. The highest available setting for hysteresis rate will be 5 min-1 below the programmed base rate. Reduction
Maximum AF 5. In dual-chamber modes, the maximum ventricular refractory period is 325 ms.

4 2 2
Suppression Rate (min-1) 80-200 in steps of 10; 225-300 in steps of 25 6. Values 0,1-0,4 not available in a unipolar sense configuration. SAR SAR SAR
Atrial Tachycardia 7. Sensitivity is with respect to a 20 ms haversine test signal.
Detection Rate (min-1) 110-200 in steps of 10; 225-300 in steps of 25 1.5T 1.5T
8. During atrial NIPS in dual-chamber modes, the shortest Coupling Interval will be limited by the programmed AV/PV delay. 1.5T
Auto Mode Switch Off; DDD(R) to DDI(R); DDD(R) to DDT(R); DDD(R) to VVI(R); 9. S1 Burst Cycle is applied at the preprogrammed S1 cycle length.
DDD(R) to VVT(R); VDD(R) to VVI(R); VDD(R) to VVT(R) 10. A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% DDD pacing @ 60 bpm; AutoCapture™ Pacing System OFF; SEGMs ON
AMS Base Rate (min-1) 40-170 in steps of 5 11. Terms and conditions apply; refer to the warranty for details.
12. Healey JS, Connolly SJ, Gold MR, et al. on behalf of the ASSERT investigators. Sub-clinical atrial fibrillation and the risk of stroke:
ASymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the AF Reduction atrial pacing Trial (ASSERT). N Engl J
Med 2012; 366:120 –129. 80% Reduction

4 2 2
SAR SAR SAR

1.5T 1.5T 1.5T

Customer Support: 46-8-474-4756

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing
of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for
product availability in your country.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or
one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks
of St. Jude Medical, Inc. and its related companies. © 2015 St. Jude Medical, Inc. All Rights Reserved.

SJM-END-1214-0012 | This document is approved for international use only.