Assurity MRI

Size and Longevity

The small size of Assurity — combined with its outstanding longevity — may mean your patients could experience fewer complications and greater comfort. In particular, greater longevity reduces the chance of potential device replacement (with potentially less risk for infection and complications).⁴

Assurity features include:

MRI Ready

The Assurity MRI pacemaker and Tendril MRI™ and Tendril STS pacing leads allow full body, 1.5 and 3T MRI scans.^†

• Meets industry-standard MRI testing parameters
• Capable of full body 1.5T and 3T 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

The Tendril MRI, LPA1200M pacing lead is only 1.5T MR Conditional when used with the Assurity MRI pacemaker.

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:

Cost-Effective

• Reimbursement available for remote monitoring
• Remote monitoring can reduce spending over 3 years by 9% ($4,356 per patient)⁵
• Automatic scheduling of remote monitoring lets your clinic schedule and bill all appropriate device checks

References

*Among pacemakers < 15cc in total volume; as of September 2017.¹
** 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).
***Single-chamber model; Dual-chamber model warranty is 8 years; terms and conditions apply; refer to the warranty for details.
^†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. St. Jude Medical Research Report: Competitive Product Review: Wireless Pacemakers. No. 60082151. Rev B.
2. St. Jude Medical. Data on file, Report 60048640. Market Research Report: Pacemaker Size and Shape. 2016.
3. Rajappan K, Permanent pacemaker implantation technique: Part I and II. Heart. 2009;95(3), 259-264, 334-342.
4. Romeyer-Bouchard C, Da Costa A, Dauphinot V, Messier M, Bisch L, Samuel B, ... Isaaz K. Prevalence and risk factors related to infections of cardiac resynchronization therapy devices. European Heart Journal. 2010;31(2), 203-210.
5. Sutton B, Zigler J, Gopinathannair R, Deam G, & Graver R. Improved health outcomes and cost-savings with remote monitoring of cardiac implantable electronic devices. Heart Rhythm Society Meeting; May, 2013; Denver, CO. Retrospective claims analysis of Medicare 5% sample Limited Data Set Standard Analytical Files claims and enrollment data across all manufacturers.
6. Mittal S, Piccini J, Fischer A, Snell J, Dalal N, & Varma N. Remote monitoring of ICD patients is associated with reduced mortality irrespective of device type. Heart Rhythm Society Meeting; May 2014; San Francisco, CA. This was a retrospective data review and had limitations.
7. Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, ... Marzegalli M. 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, 2012;125(24), 2985-2992.
8. Crossley GH, Boyle A, Vitense H, Chang Y, & Mead RH. 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. 2011;57(10), 1181-1189.