PRODUCT CATALOG

Cardiac Rhythm Management | Pacemakers | Single-Chamber (Pacemakers)

Assurity MRI™

Single-Chamber Pacemaker

Product Highlights

The Assurity MRI™ pacemaker was designed to allow patients to undergo MRI scans:

  • When combined with the Tendril MRI™ LPA1200M lead, the MRI Ready device allows full-body, MRI scans*
  • 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
  • Physician preferred size and physiologic shape minimize pocket size1,2
  • InvisiLink™ wireless telemetry, in conjunction with the Merlin@home™ transmitter and Merlin.net™ Patient Care Network (PCN), allows for daily remote monitoring and follow-up
  • A suite of state-of-the-art features—such as automaticity, and Ventricular AutoCapture™ pacing system for ventricular implants, ACap™ Confirm, AF Suppression™ algorithm and AT/AF diagnostics for atrial implants, and SenseAbility™ technology—are designed to deliver optimal therapy for patients at implant and throughout their lives
  • Outstanding longevity provides 13.9 years of service life,3 which is supported by a 10-year warranty4
  • Six-month ERI-EOL interval
Assurity MRI | Merlin@home Compatible | MR Conditional


Ordering Information

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM1272 47 x 50 x 6 20 10.4 (± 0.5) IS-1
Reorder Number Description Insulation Fixation Minimum Introducer (F) Connector Length (cm)
LPA1200M Tendril MRI™ Pacing Lead Optim™ Ext/Ret helix 8 IS-1 bipolar 46, 52, 58

*See MRI Conditional Parameters

1. SJM Market Research Report: Pacemaker Size and Shape. 2012. No. 60048640.

2. SJM Market Research Report: Competitive Product Review: Wireless Pacemakers. 2016. No. 60082151

3. A,V = 2.5 V @ 0.4 ms; 500 ohms; 100% VVI pacing @ 60 bpm; AutoCapture™ Pacing System OFF; SEGMs ON.

4. Terms and conditions apply; refer to the warranty for details.

Rx Only

 

Brief Summary: Prior to using these devices, please review the User’s Manual 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 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.

 

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.

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.

©2018 St. Jude Medical, Inc. All rights reserved.

SJM-ASY-1216-0072

Customer Support: 855-478-5833

Last Updated: February 1, 2017