Assurity MRI™ Dual Chamber Pacemaker
Abbott
Product Highlights
- MRI-Ready device tested in combination with MR Conditional leads for full-body scans using a 1.5T and 3T Tesla field strength MRI Scanner.
- Physician-preferred size and physiologic shape minimize pocket size.
- Outstanding longevity provides 9.4 years of service life, supported by an eight-year warranty.
- InvisiLink™ wireless telemetry system, in conjunction with the Merlin@home™ transmitter and Merlin.net™ Patient Care Network (PCN), allows for daily remote monitoring and follow-up.
- The only pacemaker with programmable AT/AF alerts specifically indicated for detecting atrial tachyarrhythmias, which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF.
- A suite of state-of-the-art features – complete automaticity (atrial and ventricular), Ventricular Intrinsic Preference (VIP™) technology, AF Suppression™ algorithm and SenseAbility™ sensing algorithm technology – are designed to deliver optimal therapy for patients at implant and throughout their lives.
- Six-month ERI-EOL interval.
Ordering Information
MRI-Ready Pacing System
| MODEL NUMBER | DESCRIPTION | DIMENSIONS (H × W × T, MM) | WEIGHT (G) | VOLUME (CC) | CONNECTOR |
|---|---|---|---|---|---|
| PM2272 | Assurity MRI™ Pacemaker | 47 × 50 × 6 | 20 | 10.4 (± 0.5) | IS-1 |
| MODEL NUMBER | DESCRIPTION | INSULATION | FIXATION | MINIMUM INTRODUCER (F) | CONNECTOR | LENGTH (CM) |
|---|---|---|---|---|---|---|
| LPA1231 | UltiPace™ Pacing Lead | Optim™ | Ext/Ret helix | 6 | IS-1 bipolar | 46, 52, 58, 65 |
| 2088TC | Tendril™ STS Pacing Lead | Optim™ | Ext/Ret helix | 6 | IS-1 bipolar | 46, 52, 58, 65, 100** |
**Not MR Conditional
Product Specifications
PHYSICAL SPECIFICATIONS
| Parameter | Settings |
|---|---|
| Model | PM2272 |
| Telemetry | RF |
| Dimensions (mm) | 47 × 50 × 6 |
| Weight (g) | 20 |
| Volume (cc) | 10.46 |
| Connector | IS-1 |
| Remote Monitoring | Compatible with Merlin@home™ Transmitter |
RATE/TIMING
| Parameter | Settings |
|---|---|
| Atrial Pace Refractory (ms) | 190-400 in steps of 30; 440; 470 |
| Atrial Sense Refractory (ms) | 93; 125; 157; 190-400 in steps of 30; 440; 470 |
| Paced AV Delay (ms) | 25; 30-200 in steps of 10; 225-300 in steps of 25; 350 |
| Base Rate (bpm) | 30-130 in steps of 5; 140-170 in steps of 10 |
| Far-Field Protection Interval (ms) | 168 |
| Hysteresis Rate (bpm) | Off; 309-150 in steps of 5 |
| Search Interval (min) | Off; 1; 5; 10; 15; 30 |
| Cycle Count | 1-16 in steps of 1 |
| Intervention Rate (bpm) | Off; Same Base Rate; 80-120 in steps of 10; Intrinsic +0; Intrinsic +10; Intrinsic +20; Intrinsic +30 |
| Intervention Duration (min) | 1-10 in 1 minute intervals |
| Recovery Time | Fast; Medium; Slow; Very Slow |
| Maximum Tracking Rate (bpm) | 90-130 in steps of 5; 140-210 in steps of 10 |
| Mode | AOO(R); AAI(R); AAT(R); VOO(R); VVI(R); VVT(R); VDD(R); DOO(R); DVI(R); DDI(R); DDD(R); Pacing Off |
| Post Ventricular Atrial Blanking (ms) | 60-200 in steps of 10; 225; 250 |
| PVARP (ms) | 125-500 in steps of 25 |
| Sensed AV Delay (ms) | 25; 30-200 in steps of 10; 225-325 in steps of 25 |
| Rest Rate (bpm) | Off; 30-150 in steps of 5 |
| Rate Responsive AV Delay | Off; Low; Medium; High |
| Rate Responsive PVARP/VREF | Off; Low; Medium; High |
| Shortest AV Delay (ms) | 25-50 in steps of 5; 60-120 in steps of 10 |
| Shortest PVARP/VREF (ms) | 125-475 in steps of 25 |
| Ventricular Blanking (ms) | Auto; 12-52 in steps of 4 |
| Ventricular Pace/Sense Refractory¹⁰ (Fixed) (ms) | 125; 160-400 in steps of 30; 440; 470; 500 |
RATE-MODULATED PARAMETERS
| Parameter | Settings |
|---|---|
| Sensor | On; Off; Passive |
| Maximum Sensor Rate (bpm) | 80-150 in steps of 5; 160-180 in steps of 10 |
| Reaction Time | Very Fast; Fast; Medium; Slow |
| Recovery Time | Fast; Medium; Slow; Very Slow |
| Slope | Auto (-1); Auto (+0); Auto (+1); Auto (+2); Auto (+3); 1-16 in steps of 1 |
| Threshold | Auto (-0.5); Auto (+0.0); Auto (+0.5); Auto (+1.0); Auto (+1.5); Auto (+2.0); 1–7 in steps of 0.5 |
Product Specifications
OUTPUT/SENSING
| Parameter | Settings |
|---|---|
| ACap™ Confirm Features | On; Off; Monitor |
| Primary Pulse Configuration | Bipolar |
| Backup Pulse Configuration | Bipolar |
| Backup Pulse Amplitude (V) | 5.0 |
| Search Interval (hours) | 8; 24 |
| A or V Pulse Amplitude (V) | 0.25-4.0 in steps of 0.25; 4.5-7.5 in steps of 0.5 |
| A or V Pulse Width (ms) | 0.05; 0.1-1.5 in steps of 0.1 |
| A or V Pulse Configuration | Unipolar (tip-case); Bipolar (tip-ring) |
| A or V Sense Configuration | Unipolar Tip (tip-case); Bipolar (tip-ring); Unipolar Ring (ring-case) |
| Atrial Sensitivity (mV) | 0.1-0.49 in steps of 0.1; 0.5; 0.75–2.0 in steps of 0.25; 2.5–4.0 in steps of 0.5; 5.0 |
| Ventricul Sensitivity (mV) | 0.5-5.0 in steps of 0.5; 6-10 in steps of 1.0; 12.5 |
| Ventricular AutoCapture™ | On; Off |
| Pacing System | Unipolar; Bipolar |
| Primary Pulse Configuration | Unipolar; Bipolar |
| Backup Pulse Configuration | Unipolar; Bipolar |
| Backup Pulse Amplitude (V) | 5.0 |
| Search Interval (hours) | 8; 24 |
| AutoCapture Paced/Sensed AV Delay (ms) | 50/25; 100/70; 120/100 |
| SenseAbility™ Sensing | Off; On (Automatic sensitivity control adjustment for atrial and ventricular events) |
| A Max Sensitivity (mV) | 0.2-1.0 in steps of 0.1 |
| V Max Sensitivity (mV) | 0.2-2.0 in steps of 0.1 |
| Threshold Start | (Atrial and Ventricular Post-Sense) 50; 62.5; 75; 100% (Atrial Post-Pace) 0.2-3.0 in steps of 0.1 mV |
| Decay Delay (ms) | (Ventricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 (Atrial Post-Pace) 0; 30; 60; 95; 125; 160; 190; 220 (Ventricular Post-Pace) Auto; 0; 30; 60; 95; 125; 160; 190; 220 |
AF MANAGEMENT
| Parameter | Settings |
|---|---|
| AF Suppression™ Algorithm | Off; On |
| Lower Rate Overdrive (bpm) | 10 |
| Upper Rate Overdrive (bpm) | 5 |
| No. of Overdrive Pacing Cycles | 15-40 in steps of 5 |
| Rate Recovery (ms) | 8; 12 |
| Maximum AF Suppression Rate (bpm) | 80-150 in steps of 5; 160-180 in steps of 10 |
| Atrial Tachycardia Detection Rate (bpm) | 110-200 in steps of 10; 225–300 in steps of 25 |
| Auto Mode Switch | Off; DDD(R) to DDI(R); DDD(R) to VVI(R); VDD(R) to VVI(R) |
| AMS Base Rate (bpm) | 40-170 in steps of 5 |
Product Specifications
STORED ELECTROGRAMS
| Parameter | Settings |
|---|---|
| Options | Off; Low; High |
| Priority Options | 1; 2; 3 |
| Channel | 1; 2; 3 |
| Triggers | Off; Low; High |
| Advanced Hysteresis | Off; Low; High |
| AMS Entry/AMS Exit/ AMS Entry and Exit | Off; Low; High |
| AT/AF Detection | Off; Low; High |
| Magnet Response | Off; Low; High |
| High Atrial Rate | Off; Low; High |
| Rate (bpm) | 125-300 in steps of 25 |
| No. of Consecutive Cycles | 2; 3; 4; 5; 10; 15; 20 |
| High Ventricular Rate | Off; Low; High |
| Rate (bpm) | 125-300 in steps of 25 |
| No. of Consecutive Cycles | 2; 3; 4; 5; 10; 15; 20 |
| PMT Termination | Off; Low; High |
| Consecutive PVCs | Off; Low; High |
| No. of Consecutive PVCs | 2; 3; 4; 5 |
| Noise Reversion | Off; Low; High |
MRI SETTINGS
| Parameter | Settings |
|---|---|
| MRI Mode | AOO; VOO; DOO; Pacing Off |
| MRI Base Rate | 85 bpm; 30-120 bpm in steps of 5 bpm |
| MRI Paced AV Delay | 120 ms; 25, 30-120 ms in steps of 10 ms |
| MRI Atrial Pulse Configuration | Bipolar |
| MRI Atrial Pulse Amplitude | 5.0 V; 7.5 V |
| MRI Atrial Pulse Width | 1.0 ms |
| MRI RV Pulse Configuration | Bipolar |
| MRI RV Pulse Amplitude | 5.0 V; 7.5 V |
| MRI RV Pulse Width | 1.0 ms |
MRI SCAN PARAMETERS™
| Lead Model | Magnet (Tesla) | RF Transmit Conditions | Scan Region |
|---|---|---|---|
| Tendril™ STS Pacing Lead 2088TC (lead lengths: 46, 52, 58 cm) | 1.5 T / 3 T | Normal Operating Mode | Full-body |
| UltiPace™ Pacing Lead LPA1231 (Lead lengths 46, 52, 58, 65 cm) | 1.5 T / 3 T | Normal Operating Mode | Full-body |
Product Specifications
OTHER
| Parameter | Settings |
|---|---|
| A and V Lead Monitoring | Monitor; Auto Polarity Switch |
| A and V Low Impedance Limit (Ω) | 100–500 in steps of 50 |
| A and V High Impedance Limit (Ω) | 750–2500 in steps of 250; 3000 |
| Lead Type | Uncoded; Unipolar; Bipolar |
| Magnet Response | Off; Battery Test |
| Negative AV Hysteresis Search (ms) | Off; -10 to -120 in steps of 10 |
| NIPS Options | Atrial or Ventricular |
| Stimulation Chamber | Atrial or Ventricular |
| Coupling Interval (ms) | 100-800 in steps of 10 |
| S1 Count | 2-25 in steps of 1 |
| S1¹²; S2; S3 and S4 Cycle (ms) | Off; 100-800 in steps of 10 (Fixed or Adaptive) |
| Ventricular Support Rate (bpm) | Off; 30–95 in steps of 5 |
| Sinus Node Recovery Delay (sec) | 1; 2; 3; 4; 5 |
| PMT Options | Off; Passive; Atrial Pace |
| PMT Detection Rate (bpm) | 90-180 in steps of 5 |
| PVC Response | Off; Atrial Pace |
| Ventricular Intrinsic Preference, VIP™ (ms) | Off; 50-150 in steps of 25; 160–200 in steps of 10 |
| VIP Search Interval | 30 sec.; 1; 3; 5; 10; 30 min. |
| VIP Search Cycles | 1; 2; 3 |
| Ventricular Safety Standby | Off; On |
| Diagnostic Trends | AT/AF Activity; Exercise; Lead Impedance; P and R Wave; A and V Threshold |
References
- Abbott. Data on file. Report 60048640. Market Research Report: Pacemaker Size and Shape.
- Rajappan K. Permanent pacemaker implantation technique: Part I. Heart. 2009;95(3):259-264.
End Notes
- A,V = 2.5 V @ 0.4 ms; 500 ohms; 100% DDD pacing @ 60 bpm; AutoCapture™ Pacing System OFF; SEGMS ON.
- Terms and conditions apply; refer to the warranty for details.
- 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.
- ± 0.5 cc
- Programming options dependent on pacing mode.
- This parameter is not programmable.
- The highest available setting for hysteresis rate will be 5 bpm below the programmed base rate.
- In dual-chamber modes, the maximum ventricular refractory period is 325 ms.
- Sensitivity is with respect to a 20 ms haversine test signal.
- Values 0.1-0.4 not available in a unipolar sense configuration.
- During atrial NIPS in dual-chamber modes, the shortest coupling interval will be limited by the programmed AV/PV delay.
- S1 burst cycle is applied at the preprogrammed S1 cycle length.
Rx Only
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.
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. Dual-Chamber Pacing is indicated 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 and other causes have been ruled out. 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. AF Suppression™ algorithm is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
Contraindications
Dual-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. 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 fibrillation, or silent atria, may provide no benefit beyond that of single-chamber pacing in such patients. Single-Chamber Ventricular Demand Pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffera 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.
Potential Adverse Events
The following are potential complications associated with the use of any pacing system: air embolism; body rejection phenomena; cardiac tamponade or perforation; hematoma, bleeding hematoma, seroma; formation of fibrotic tissue, local tissue reaction; inability to interrogate or program due to programmer or device malfunction; infection; erosion; interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic; lead malfunction due to conductor fracture or insulation degradation; loss of capture or sensing due to lead dislodgement or reaction at the electrode/tissue interface; 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; pacemaker migration or pocket erosion; pectoral muscle or diaphragmatic stimulation; phrenic nerve stimulation; pneumothorax/hemothorax; device migration and pocket erosion; endocarditis; excessive bleeding; induced atrial or ventricular arrhythmias; myocardial irritability; pericardial effusion; pericardial rub; pulmonary edema; rise in threshold and exit block; valve damage; death.
Refer to the User's Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
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