Assurity MRI Pacemaker

CARDIOVASCULAR

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THE WORLD’S SMALLEST, LONGEST-LASTING WIRELESS MRI PACEMAKER*

The Assurity MRI™ pacemaker offers premium device features in a MR Conditional system, without compromising device performance or longevity. Among the thinnest devices¹ on the market, its small size, combined with its outstanding longevity, may mean your patients could experience fewer complications and greater comfort.

SIZE AND LONGEVITY

Designed with a physician-preferred size and physiologic shape,¹ the Assurity MRI pacemaker is the market’s smallest¹ wireless MR Conditional pacemaker, enabling you the option of creating a smaller incision and pocket size.² Greater longevity reduces the chance of potential device replacement (with potentially less risk for infection and complications).³

Features include:

10-year device longevity⁴
Industry-leading 10-year warranty⁵
10 cc in volume⁶
6 mm thickness — among the thinnest devices on the market^6,*
Confidence in device reliability — even in a MRI environment

MRI READY

The Assurity MRI pacemaker and Tendril MRI™ lead are designed specifically to allow full-body, 1.5T MRI scans** that meet certain scan conditions.

Meets industry-standard MRI testing requirements
Capable of full body 1.5T MRI imaging scans
SJM MRI Activator™ handheld device helps reduce required steps before and after scanning, resulting in more efficient workflow than conventional MRI pacemakers

WIRELESS REMOTE MONITORING

The Assurity MRI pacemaker assists you in monitoring patient disease status and device performance daily with automatic remote monitoring.

Standard of Care

As the new standard of care,*** wireless remote monitoring significantly improves patient outcomes and reduces hospital admissions:

27% reduction in all - cause mortality over 3 years⁷
2.4x greater probability of survival⁸
36% reduction in cardiac or device-related emergency room or hospital visits⁹
18% reduction in mean length of stay, with an estimated savings of $1,793 per stay¹⁰

Cost Effective

Reimbursement is available for remote monitoring
Remote monitoring can reduce spending over 3 years by 9% ($4,356 per patient)⁷
Automatic scheduling of remote monitoring allows your clinic to schedule and bill all appropriate device checks

See more about the Assurity MRI™ pacemaker’s premium features and technology.

EMPOWERING CARDIAC ARRHYTHMIA MANAGEMENT

When it comes to understanding and managing cardiac arrhythmias, we are your partner for life. Our vision is to transform the treatment of cardiac arrhythmias by designing cost‐saving technologies that span the patient care continuum and improve therapy outcomes. Read more about our approach to cardiac arrhythmia management.

RESOURCES AND DOCUMENTATION

Product Manuals

Reimbursement Information

MRI Ready Resources and Scan Parameters

How Wireless Remote Monitoring Improves Clinical Benefts

Using Remote Monitoring: A Practical Value Case Study

REFERENCES

*Among pacemakers < 15cc in total volume; as of February 1, 2017. St. Jude Medical. St. Jude Medical Research Report: Competitive Product Review: Wireless Pacemakers. No. 60082151. Rev B.
**See MRI Ready Systems Manual for device and lead combinations and associated MRI scan parameters.
***Per Class 1A Heart Rhythm Society recommendation.
1. St. Jude Medical. (2016). Data on file, Report 60048640. Market Research Report: Pacemaker Size and Shape.
2. Rajappan, K. (2009). Permanent pacemaker implanation technique: Part I and II. Heart, 95(3), 259-264, 334-342. http://dx.doi.org/10.1136/hrt.2007.132753
3. Romeyer-Bouchard, C., Da Costa, A., Dauphinot, V., Messier, M., Bisch, L., Samuel, B, ... Isaaz, K. (2010). Prevalence and risk factors related to infections of cardiac resynchronization therapy devices. European Heart Journal, 31(2), 203-210. http://dx.doi.org/10.1093/eurheartj/ehp421
4. Dual-chamber model; A,V = 2,5 V @ 0,4 ms; 600 ohms; 100% DDD pacing @ 60 bpm; AutoCapture™ pacing system OFF; SEGMs ON (10 years). Single-chamber model; A,V = 2,5 V @ 0,4 ms; 600 ohms; 100% VVI pacing @ 60 bpm; AutoCapture™ pacing system OFF; SEGMs ON (15 years).
5. Single-chamber model; Dual-chamber model warranty is 8 years; terms and conditions apply; refer to the warranty for details.
6. St. Jude Medical. Data on file, Report 60082151. Competitive Product Review: Wireless Pacemakers.
7. Sutton, B., Zigler, J., Gopinathannair, R., Deam, G., & Graver, R. (2013, May). Improved health outcomes and cost-savings with remote monitoring of cardiac implantable electronic devices. Presented at the meeting of the Heart Rhythm Society, Denver, CO. Retrospective claims analysis of Medicare 5% sample Limited Data Set Standard Analytical Files claims and enrollment data across all manufacturers.
8. Mittal, S., Piccini, J., Fischer, A., Snell, J., Dalal, N., & Varma, N. (2014, May). Remote monitoring of ICD patients is associated with reduced mortality irrespective of device type. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA. This was a retrospective data review and had limitations.
9. Landolina, M., Perego, G. B., Lunati, M., Curnis, A., Guenzati, G., Vicentini, A., ... Marzegalli, M. (2012). Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: The evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation, 125(24), 2985-2992. http://dx.doi.org/10.1161/CIRCULATIONAHA.111.088971
10. Crossley, G. H., Boyle, A., Vitense, H., Chang, Y., & Mead, R. H. (2011) The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: The value of wireless remote monitoring with automatic clinician alerts. Journal of the American College of Cardiology, 57(10), 1181-1189. http://dx.doi.org/10.1016/j.jacc.2010.12.012

PREMIUM FEATURES

The Assurity MRI™ pacemaker offers premium technology designed to reduce complications and provide greater for the comfort for patients.

PHYSICIAN-PREFERRED SIZE AND SHAPE

Minimize pocket size with the Assurity MRI™ pacemaker’s physician-preferred size¹ and physiologic shape.²

DAILY REMOTE MONITORING AND FOLLOW-UP

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.

AUTOCAPTURE™ PACING SYSTEM

Offers the maximum in threshold adaptability and patient safety with ventricular Beat-by-Beat™ capture confirmation²
Automatically delivers a 5.0V backup safety pulse when noncapture is detected, and may be programmed to either a bipolar or unipolar configuration

REAL-TIME ELECTROGRAM WAVEFORM

Real-time electrogram (EGM) waveform, as well as the associated event markers that precede and follow a specific triggering event, can be programmed to automatically record up to 14 minutes of stored EGMs when encountering one or more programmable trigger options.

SPECIFIC FEATURES FOR OUR DUAL- AND SINGLE-CHAMBER MODELS

Dual-Chamber

State-of-the-Art Features

Complete automaticity (atrial and ventricular)
Ventricular Intrinsic Preference (VIP™) technology — reduces right ventricular (RV) pacing and heart-failure hospitalization;³ provides ventricular support on a beat-by-beat basis to optimize patient safety and support intrinsic heart rhythm³
AF Suppression™ algorithm and SenseAbility™ technology — designed to deliver optimal therapy for patients at implant and throughout their lives

Programmable AT/AF Alerts

The only pacemaker with programmable AT/AF alerts specifically indicated for detecting atrial tachyarrhythmias (ATs), which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of atrial fibrillation (AF).⁴

Longevity

Outstanding longevity provides 9.4 years of service life⁵ supported by an 8-year warranty⁶
6-month elective replacement indicator-end of life (ERI-EOL) interval

Single-Chamber

State-of-the-Art Features

Automaticity
Ventricular AutoCapture™ pacing system for ventricular implants
SenseAbility™ technology

Longevity

Outstanding longevity provides 13.9 years of service life⁷ supported by an 10-year warranty⁶
6-month ERI-EOL interval

BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

The Assurity MRI™ pacemaker is part of our cardiac arrhythmia management portfolio. Our vision is to transform the treatment of cardiac arrhythmias by designing cost-saving technologies that improve therapy outcomes. Read more about our approach to cardiac arrhythmia management.

REFERENCES

1. St. Jude Medical. (2012). Data on file, Report 60048640. Market Research Report: Pacemaker Size and Shape
2. Lau,C. & Sui, C. (2010). Pacing technology: Advances in pacing threshold management. 浙江大学学报：B卷英文版 / Journal of Zhejiang University Science, 11(8), 634-638. http://dx.doi.org/10.1631/jzus.B1001016
3. Faulknier, B., & Richards, M. (2012, December). The association of the use of the Ventricular Intrinsic Preference (VIP™) feature with heart failure hospitalization in pacemaker patients. Presented at the International Symposium on Progress in Clinical Pacing, Rome, Italy.
4. Healey, J. S., Connolly, S. J., Gold, M. R., Israel, C. W., Van Gelder, I. C., Capucci, A., … Hohnloser, S. H. (2012). Subclinical atrial fibrillation and the risk of stroke. New England Journal of Medicine, 366, 120-129. http://dx.doi.org/10.1056/NEJMoa1105575
5. A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% DDD pacing @ 60 bpm; AutoCapture™ pacing system OFF; SEGMs ON.
6. Terms and conditions apply; refer to the warranty for details.
7. A,V = 2,5 V @ 0,4 ms; 500 ohms; 100% VVI pacing @ 60 bpm; AutoCapture™ pacing system OFF; SEGMs ON.

CLINICAL ADVANTAGES

In addition to allowing for full-body, 1.5T MRI scans,* the Assurity MRI™ pacemaker provides other clinical benefits.

MINIMIZE RISK OF HEART FAILURE HOSPITALIZATION

Unnecessary right ventricular (RV) pacing can exacerbate heart conditions:

Pacing > 40% can lead to increased HF hospitalizations and mortality¹
Patients with low RV pacing (0-9%) have the same negative outcomes as those with high RV pacing (40-49%)²

The Abbott Ventricular Intrinsic Preference (VIP™) algorithm with dynamic AV delay is clinically proven to reduce unnecessary RV pacing.³ The VIP algorithm is shown to reduce heart-failure-related hospitalization³ and offers RV pacing at desirable levels (10-19%)³

EARLY INSIGHT

The Assurity MRI pacemaker works together with a wireless remote monitoring system. Remote monitoring capabilities, combined with the audible patient notifier, provide earlier notification of actionable clinical events—allowing you to detect patient status changes sooner.

The ASSERT clinical trial has shown that subclinical atrial tachyarrhythmias (AT) are associated with a 2.5-fold increased risk of stroke or systemic embolism⁴
Remote monitoring has been shown to reduce mortality in pacemaker patients⁵
The Assurity MRI pacemaker can help you identify patients at risk for stroke earlier, with clinically proven AT/AF diagnostic tools⁴
The Abbott remote follow-up system, Merlin.net™ Patient Care Network (PCN), reduces clinician^6,7 and patient follow-up costs⁷
Wireless, radio-frequency telemetry offers faster access to clinical data, increasing the possibility for clinical efficiency at implant and follow-up⁸

BUILDING COMPREHENSIVE CARDIAC ARRHYTHMIA MANAGEMENT

REFERENCES

*See MRI Scan Parameters—Lead Models in Lead Models in MRI Scan Parameters.
1. Sweeney, M. O., Hellkamp, A. S., Ellenbogen, K. A., Greenspon, A. J., Freedman, R. A., Lee, K. L. & Lamas, G. A. (2003) Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation, 107, 2932-2037. http://dx.doi.org/10.1161/01.CIR.0000072769
2. Olshansky, B., Day, J., Lerew, D., Brown, S., & Stolen, K. (2007). Eliminating right ventricular pacing may not be best for patients requiring implantable cardioverter–defibrillators. HeartRhythm, 4(7), 886-891. http://dx.doi.org/10.1016/j.hrthm.2007.03.031
3. Faulknier, B., Richards, M. (2012, Dec 4-7). The association of the use of the Ventricular Intrinsic Preference (VIP™) feature with heart failure hospitalization in pacemaker patients. Paper presented at the XV International Symposium on Progress in Clinical Pacing, Rome, Italy.
4. Healey, J. S., Connolly, S. J., Gold, M. R., Israel, C. W., Van Gelder, I. C., Capucci, A., … Hohnloser, S. H. (2012). Subclinical atrial fibrillation and the risk of stroke. New England Journal of Medicine, 366, 120-129. http://dx.doi.org/10.1056/NEJMoa1105575
5. Mittal, S. (2014, May). Increased adherence to remote monitoring is associated with reduced mortality in both pacemaker and defibrillator patients. Presented at the meeting of the Heart Rhythm Society, San Francisco, CA.
6. Lazarus, A. (2007). Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: Analysis of a worldwide database. Pacing and Clinical Electrophysiology, 30(1), S2-S12. http://dx.doi.org/10.1111/j.1540-8159.2007.00595.x
7. St. Jude Medical. (2009). Remote Monitoring. Technical Monograph; GMCRM494.
8. Crossley, G. H., Boyle, A., Vitense, H., Chang, Y., Mead, R. H., & CONNECT Investigators. (2011). The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: The value of wireless remote monitoring with automatic clinician alerts. Journal of the American College of Cardiology, 57(10), 1181-1189. http://dx.doi.org/10.1016/j.jacc.2010.12.012

ASSURITY MRI™

DUAL-CHAMBER PACEMAKER

Ordering Information

Reorder Number	Description	Dimensions (H x W x T, mm)	Weight (g)	Volume (cc)	Connector
PM2272	Assurity MRI Pacemaker	47 x 50 x 6	20	10.4 (± 0.5)	IS-1

SINGLE-CHAMBER PACEMAKER

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 bipolar

INDICATIONS, SAFETY & WARNINGS

Assurity MRI™

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.

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ASSURITY MRI PACEMAKER