Print
Share
Request More Information

Accent MRI™ Pacemaker

This device is commercially available for use in select international markets.

Everything and MRI

The Accent MRI pacemaker, with the Tendril MRI lead, is an MRI conditional system, offering safe performance of a full-body MRI scan on the patient using a 1.5 T (Tesla) field-strength MRI scanner.1 An optional, easy-to-use hand-held unit (SJM MRI Activator™ device) can be applied to enable and disable pre-programmed MRI settings, which is designed to simplify workflow and increase clinic efficiency. The Accent MRI pacemaker is the first MRI conditional pacemaker to offer the option of wireless telemetry for streamlined patient management.

1 MRI conditional pacemaker system; an MRI conditional pacing system is conditionally safe for use in the MRI environment when used according to the instructions in this manual. See the St. Jude Medical MRI Procedure Information document prior to performing an MRI scan.

 

This product is not approved by the United States FDA.

 

Materials & Links

accent-mri-pacemaker
Overview

The MRI They May Need

There is a growing need for a pacemaker system that allows the patient to receive the benefits offered by MRI scanning. The Accent MRI™ pacemaker system1 from St. Jude Medical allows for full-body, high-resolution MRI scans to accommodate patients' future medical needs.

  • Safe MRI conditional compatibility to meet the needs of patients
  • Full-body scanning with no zone restrictions for full coverage1
  • High-resolution scanning for superior image quality

pdf Do Pacemaker Patients Need an MRI? [PDF 716KB]

State-of-the-Art

The state-of-the-art device features:

  • InvisiLink™ Wireless Telemetry or inductive remote follow-up utilising a wand, in conjunction with the Merlin@home™ transmitter and Merlin.net™ Patient Care Network (PCN), allows for daily remote monitoring and follow-up.
  • AT/AF Alerts can be programmed to notify patients and/or their clinics when a programmed AT/AF threshold or continuous episode duration has been exceeded, or when a high ventricular rate accompanies the AT/AF episode.
  • A suite of features—complete automaticity (atrial and ventricular), Ventricular Intrinsic Preference (VIP™) technology, QuickOpt™ timing cycle optimisation, the AF Suppression™ algorithm and SenseAbility™ technology—is designed to deliver optimal therapy for patients at implant and throughout their lives.
  • Industry-leading longevity offers 9,1 years of service life,2 which is supported by a 7-year warranty.3

Safe

The Accent MRI™ pacemaker has been designed and tested for safe performance of a full-body MRI scan, without zone restrictions, using a 1,5 T (Tesla) field-strength MRI scanner.1 The MRI conditional device:

  • Allows a maximum whole body averaged specific absorption rate (SAR) of 4 watts per kilogram (W/kg) for high image resolution.
  • Must be used in conjunction with an MRI lead from St. Jude Medical.

Dr. Pakarinen Accent MRI™ Pacemaker Testimonial

Dr. Sami Pakarinen, Cardiologist, M.D., Helsinki University Hospital – Finland shares his experience with Accent MRI™ pacing system. His interview covers the importance of MRI conditional systems as well as implant considerations. In a second step, he also shares his thoughts on a MRI scan case for a patient implanted with Accent MRI pacemaker and Tendril MRI™ lead.

Length: 7:58

Simplified

An optional, easy-to-use handheld 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.


Simplified

The unique SJM MRI Activator™ device allows clinicians to enable and disable pre-programmed MRI settings pre- and post-scan for increased clinic efficiency.


References

1 The St. Jude Medical™ MRI conditional pacing system can be scanned in patients under the following conditions: horizontal closed bore clinical scanner working in the Normal Operating Mode or First Level Controlled Operating Mode; static magnetic field strength of 1,5 Tesla (T) only; maximum gradient slew rate of 200 T/m/s per axis. See the MRI Procedure Information document for additional details before performing an MRI scan.

2 Model 2224 (dual-chamber device with wireless telemetry); A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% DDD pacing @ 60 bpm; AutoCapture™ Pacing System OFF; SEGMs ON

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

4 The SJM MRI Activator device is designed to enable/disable pre-programmed MRI settings quickly and easily pre- and post-scan; do not take the SJM MRI Activator device into the MRI magnet/scanner room.

*Disclaimer: This is a third-party web site. When you access this site, you are leaving the St. Jude Medical site. St. Jude Medical is not responsible for content, policies or links unrelated to St. Jude Medical that appear on this site.

Tech Specs

Accent MRI™ DR

Dual-Chamber Pacemaker
Ordering Information   View Catalog   

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM2124 52 x 53 x 6 23 13.1 (± 0.5) IS-1

Accent MRI™ DR

Dual-Chamber Pacemaker with Wireless Telemetry
Ordering Information   View Catalog   

Contents: Cardiac pulse generator

Reorder Number Dimensions (H x W x T, mm) Weight (g) Volume (cc) Connector
PM2224 52 x 53 x 6 24 13.1 (± 0.5) IS-1

Indications, Safety & Warnings
Print

Accent MRI™ DR

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.

Indications: Implantation of a dual-chamber pulse generator 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. MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St. Jude Medical MRI conditional pacing system. 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 (ICD). 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.

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, and phrenic nerve or diaphragmatic stimulation. The following, in addition to the above, are potential complications associatedwith 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, and palpitations with high-rate pacing.

Refer to the User’s Manual for more detailed indications, contraindications, warnings, precautions and potential adverse events.

Accent MRI™ DR

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.

Indications: Implantation of a dual-chamber pulse generator 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. MRI conditional pulse generator is safe for use in the MRI environment when used in a complete MRI conditional pacing system and according to the instructions in the MRI Procedure Information document for the St. Jude Medical MRI conditional pacing system. 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 (ICD). 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.

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, and 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 thanpatient activity, loss of activity-response due to sensor failure, and palpitations with high-rate pacing.

Refer to the User’s Manual for more detailed indications, contraindications, warnings, precautions and potential adverse events.

Last Updated: 22 April 2013