CARDIOVASCULAR
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Experience Advanced Detection Accuracy

Capture arrhythmia episodes correctly by significantly reducing false detections.

SharpSense™ technology harnesses the power of extra discriminators to confirm or reject detections - improving accuracy.1,2

Improve detection specificity with SharpSense technology

SharpSense technology is designed with more discriminators, improving specificity while maintaining a high relative sensitivity, to give you actionable information you can use to confidently diagnose bradycardia, pause and AF.1

See how SharpSense technology works

Confirm Rx ICM Is the Only ICM Available with an AF Indication.

SharpSense™ Technology has led to a 97% Reduction in False Detection of Events2*

Atrial Fibrillation

Actively reviews the previous 30 seconds for the presence of P-waves to discern an AF episode.

Relative Sensitivity: 97.2%1

Bradycardia

Dynamically evaluates multiple R-waves and P-waves to create customized thresholds to detect true bradycardia episodes.

Relative Sensitivity: 98.6%1

Pause

Analyzes P-wave and R-wave characteristics during the previous 6 seconds, based on customized secondary thresholds, to detect true pause episodes.

Relative Sensitivity: 98.1%1

Kaplan-Meier analysis showed that the Confirm Rx device detected signficantly more true arrhythmic episodes in more patients - and did so sooner.3

Kaplan-Meier: Confirm vs. Reveal

Diagnose difficult-to-detect arrhythmias

The Confirm Rx ICM device continously monitors patient rhythm for up to 2 years (730 days).6

84 Days

Median time to detect an AF episode in patients with Cryptogenic Stroke when using an implantable loop recorder.4†

134 Days

Median time for diagnosis in patients with Unexplained Syncope when using an implantable loop recorder.5

730 Days

Confirm Rx ICM offers up to 730 days of continuous heart monitoring — providing ample time to diagnose the most difficult-to-detect arrhythmias.6

*Determined by evaluation of real-world episodes in previously identified devices, using SharpSense Technology

This information was not collected with the Confirm Rx ICM Device and is meant to provide information to the broader class of devices.

References

  1. Design Validation Report and Trace Matrix, Insertable Cardiac Monitor (ICM) System document 60076435. Rev E. March 2019.
  2. Evaluation of Clinic Impact of Confirm Rx 1.2 Algorithm Enhancements. Abbott document 60098828. April 2019.
  3. Ip J, Jaffe B, Castellani M, et al. Arrhythmia Detection in Implantable Cardiac Monitor Randomized Clinical Trial Comparing Reveal LINQ and Confirm Rx. PACE. Sept. 24, 2020.https://doi.org/10.111/pace.14076
  4. Sanna, T., M.D., Diener, H., M.D., Ph.D., Passman, R. S., M.D., M.S.C.E., Di Lazzaro, V., M.D., Bernstein, R. A., M.D., Ph.D., Morillo, C. A., M.D., ... Brachmann, J., M.D. (2014). Cryptogenic Stroke and Underlying Atrial Fibrillation. The New England Journal of Medicine, 370(26), 2478-2486. doi:10.1056/NEJMoa1313600.
  5. Solbiati, M., et al, (2017). The diagnostic yield of implantable loop recorders in unexplained syncope: A systematic review and meta-analysis. International Journal of Cardiology, 231, 170-176.
  6. Data on file, Confirm Rx User’s Manual. ARTEN100154277 C, 2017/09
Indications, Safety & Warnings

MAT-2011391 v1.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.