The Assurity MRI™ pacemaker combines advanced features with a small size. The powerful, lightweight device allows a smaller incision and requires a smaller pocket for implantation.1,2
Equipped with the ability to connect wirelessly to Merlin.net™ Patient Care Network, the Assurity MRI pacemaker regularly communicates important information about your device to your hospital or clinic for your doctor to review. This means you may need to visit your doctor less often.
With the Assurity MRI pacemaker, you can receive magnetic resonance imaging (MRI) scans under certain parameters.
*Actual battery life depends on how frequently your device sends electrical signals to your heart, and whether it is a single- or dual-chamber device.
SINGLE CHAMBER
Dimensions (mm)
47 x 50 x 6
Weight (g)
20
DUAL CHAMBER
Dimensions (mm)
47 x 50 x 6
Weight (g)
20
The Assurity MRI™ pacemaker is made up of two components: a pulse generator and leads. The pulse generator contains the battery and electronic circuitry that send electrical pulses to the heart. This stimulates the heart and causes it to beat at a normal rhythm. The electrical pulses are very small.
The leads are thin wires that are inserted through a vein and connect the pulse generator to the heart. The leads pick up your own heart rhythm and transmit this information to the pulse generator, which adapts its response to your needs.
The programmer is an external tabletop computer that your doctor uses to change the pacemaker settings and download data stored in the pacemaker. Your doctor can adjust the therapy based on your needs over time without the need for further surgery.
The Assurity MRI pacemaker is an MR conditional device, which means that your doctor can set it so that you can get a magnetic resonance imaging (MRI) scan under certain parameters.
The Assurity MRI™ pacemaker is an MR conditional (also referred to as MRI ready) pacemaker. You can receive an MRI scan with the Assurity MRI pacemaker under certain parameters; talk with your doctor prior to having any MRI scan. Prior to have any MRI scan, talk with your doctor about the MRI scan you need and any specific parameters.
If you have an Abbott MR conditional pacemaker, download your MRI patient ID card.
Your pacemaker needs to be put into special MRI settings for you to safely undergo an MRI scan. There are two ways your doctor might do this. The first way is for your doctor to program your pacemaker to the special MRI settings ahead of time and store those settings in the pacemaker. This programming happens during a follow-up appointment. Then, when you need an MRI scan, the MRI settings are enabled by a clinician, who places a small hand-held device over your pacemaker. The hand-held device uses radio waves to communicate with your pacemaker and enable the preprogrammed MRI settings. Activating the MRI settings is painless and takes only moments. The second method involves programming your device to MRI settings when it is determined you need an MRI scan. With this method, your doctor uses the programmer to temporarily set your device to MRI settings before your MRI scan. You can then safely undergo the MRI procedure.
After the MRI scan, your device needs to be returned to its regular settings. In other words, your MRI settings need to be disabled. This can be accomplished in the same two ways in which your MRI settings were enabled. With the first method, the hand-held device is placed back over your device to disable MRI settings and enable your pacemaker to go back to its permanent settings. With the second method, the programmer is used to program your device back to its regular settings after the scan. With either method, your device is placed back to its regular settings.
Your MR conditional pacemaker is designed to give your heart the support it needs, in addition to ensuring you can receive the best in diagnostic imaging in the future should that need arise. Your doctor is the best source of information about your total overall health. It is important to discuss any questions or concerns you might have with him or her.
Cellular phones send electromagnetic signals, which can interfere with your pacemaker. You can minimize the risk by taking simple precautions, like:
Abbott currently has put special filters in our pacemakers to prevent cell phone interference. Learn more about electromagnetic interference.
Find answers to more frequently asked questions.
Assurity MRI™
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 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: 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.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
SJM-CV WEB-0718-0080a
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
