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Confirm Rx

Insertable Cardiac Monitor with SharpSense Technology

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Clinical Evidence

Clinical Evidence

Clinical Compendium

Insertable cardiac monitors are becoming a widely used diagnostic tool to detect arrhythmias. The Confirm Rx™ ICM has been updated with SharpSense™ technology to further improve the performance of the device. This compendium is a collection of product and clinical data to help you make informed decisions for your patients.

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A comparison between Reveal LINQ‡ and Confirm RX ICM1

Confirm Rx ICM data from patient-initiated transmission is approximately

20X FASTER

than Reveal LINQ‡ ICM1

Mean time to data transmission is significantly faster with Confirm Rx ICM1

Abbott Confirm Rx ICM

Medtronic Reveal LINQ‡ ICM

P-value (P<0.0001)

24 ± 103 min.1

475 ± 426 min.1

Detect AF Study2

First study to evaluate performance of the Confirm Rx ICM predecessor DM2102 ICM to detect AF published in the Journal of Cardiovascular Electrophysiology in September 2016:

  1. The 90-patient study that compared the DM2102 ICM to a Holter monitor found:
    1. DM2102 ICM can accurately detect AF episodes at least two minutes in length
    2. DM2102 ICM had a 94% AF episode sensitivity and a 93.7% Postitive Predictive Value (PPV)                                                                        
  2. The positive finding shows value of Abbott technology to detect AF
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References

  1. 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/10.1111/pace.14076
  2. Nölker, Georg & Mayer, Julia & Boldt, Leif-Hendrik & Seidl, Karlheinz & Van Driel, Vincent & Massa, Thomas & Kollum, Marc & Brachmann, Johannes & Deneke, Thomas & Hindricks, Gerhard & Jung, Werner & J. Brunner, Kyle & Kraus, Stacia & Hummer, Alexander & Lewalter, Thorsten. (2016). Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. Journal of Cardiovascular Electrophysiology. https://doi.org/10.1111/jce.13089

MAT-2011207 v1.0

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