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CARDIOVASCULAR
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Assurity

About

IMPLANT TODAY. MRI READY TOMORROW.

The Assurity MRI™ pacemaker when combined with the Tendril MRI™, Tendril STS™ or IsoFlex™ Optim™ pacing leads allows for full body, 1.5T and 3T MRI scans.*† When the Assurity MRI pacemaker is combined with Tendril STS, Tendril MRI, or IsoFlex Optim pacing leads there is no wait time between implant and MRI scan readiness. The Assurity MRI pacemaker provides an option that can help patients receive a timely diagnosis so that they can get the care they need, when they need it.

% OF MRI SCANS ARE URGENT OR EMERGENT:

22.7%1

IFU RECOMMENDED WAIT TIME FOR MRI SCAN:

42
DAYS

For Medtronic, Boston Scientific and Biotronik2-4

NO
WAIT


For Abbott*

MRI Ready

Assurity MRI pacemaker with Tendril STS or IsoFlex Optim lead now gives you 3T MRI options you didn't have before -- immediate access to MRI scans without compromising device performance.** Eliminate the six-week wait time for MRI scans that Medtronic, Boston Scientific, and Biotronik recommend.2-4 Will your patient be ready?

  • Meets industry-standard MRI testing parameters
  • Shortest delay between implantation and scan feasibility on the market for pacemakers.2-4
  • MR Conditional for full body 1.5T and 3T MRI scans*

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 according to studies performed on the US population.5-8

 

 

27% reduction

in all-cause mortality over 3 years5

 

 

36% reduction

in in cardiac or device-related emergency room or hospital visits6

 

 

24x greater

probability of survival7

 

 

18% reduction

in mean length of stay, with an estimated savings of $1,793 USD per stay8

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

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

References

*Only paritcular models and lengths are MR conditional when combined. Only Tendril STS Pacing Leads 46, 52, 58cm lengths are 1.5T and 3T MR conditional when combined with the Assurity MRI Pacemaker system. Only IsoFlex Optim Pacing Lead 1944 46, 52cm lengths  are 1.5T and 3T MR conditional when combined with the Assurity MRI Pacemaker system. Only IsoFlex Optim Pacing Lead 1948 52, 58cm lengths  are 1.5T and 3T MR conditional when combined with the Assurity MRI Pacemaker system.  The Tendril MRI, LPA1200M pacing lead is only 1.5T MR Conditional when used with the Assurity MRI pacemaker.
**No minimum length of time requirement between implant and MRI scan. Stability of pacing capture thresholds is required prior to MRI scan.
See MRI Ready Systems Manual for device and lead combinations and associated MRI scan parameters.
††Per Class 1A Heart Rhythm Society recommendation.

  1. Strom JB, Whelan JB, Shen C, Zheng SQ, Monele KJ, Kramer DB. Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices. Heart Rhythm. 2017;14(8):1138·1144. doi:10.1016/j.hrthm.2017.03.039
  2. Medtronic. Medtronic Azure™ MRI Surescan™/Astra™ MRI Surescan™ pacing systems MRI technical manual. 2016 Medtronic, M964377A001 B. Accessed December 18, 2020.
  3. Boston Scientific. Imageready™ MR Conditional Pacing Systems MRI technical guide. Boston Scientific, 360167-003 EN US 2019-07. Accessed December 18, 2020.
  4. Biotronik. ProMRI System Technical Manual. Biotronik, 5/13/20, MN062r11. Accessed January 11, 2020. Sutton B, Zigler J, Gopinathannair R, Deam G, & Graver R. Improved health outcomes ond 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.
  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. 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.
  7. 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.
  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.
Indications, Safety & Warnings

MAT-2200902 v1.0

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