OVERVIEW
TECHNOLOGY
EVIDENCE
SPECIFICATIONS
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:approach to cardiac arrhythmia management
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
How Wireless Remote Monitoring Improved Clinical Benefits
Using Remote Monitoring: A Practice 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/ehp4214. 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.111.08897110. 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