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Boston Scientific LUX-Dx II+ Insertable Cardiac Monitor and report strip.

Clinical data

Focused on clinical impact

First generation LUX-Dx™ ICM System demonstrated highest overall Positive Predictive Value (PPV)1

PPV across different arrhythmia episodes and device types

Data chart showing how the LUX-Dx ICM System compares to competitors in alert-level PPV across arrythmia types.
Graph key.

An independent manuscript evaluated real-world arrhythmia detection accuracy across insertable cardiac monitor (ICM) manufacturers. 25,826 alerts from 1140 randomly selected patients (285 patients per ICM vendor) at 25 centers were analyzed and rates of true and false positives transmissions were published.  Results show the LUX-Dx ICM System had the highest overall PPV across all ICMs evaluated.1

Download an overview (PDF)
Read the full manuscript

Clear P-wave visibility may reduce analysis time and improve clinic workflow​

90%

of P-waves clearly visible in heart cycles2*​

97%

of patients had at least one presenting ECG with visible P-waves2*​

LUX-Dx PERFORM Study preliminary results: signal quality​

Results​

Preliminary data from an interim evaluation of the LUX-Dx PERFORM study found LUX-Dx ICM Systems provided consistent P-wave visibility through 180 days post insertion, with most patients having a clearly defined P-wave in most beats within a 10 second ECG strip.3*​

P-wave Visibility in At Least One ECG at a Patient Level

Data chart showing the P-Wave visibilty of the LUX-Dx Insertable Cardiac Monitor (ICM) System through 180 days post insertion.

Reliable remote programming. Seamless connectivity.

92%

of programming changes were applied within 48 hours4*​

Real-world data​!

94%

median % of days with a data transmission for individual patients4*​

Real-world data​​!

LUX-Dx PERFORM Study preliminary results: remote programming​

Study overview​

  • Multicenter, prospective, single-arm, post-market, observational study (NCT04732728)​

  • First 369 patients enrolled were selected for interim evaluation

Results​

Preliminary data from an interim evaluation of the LUX-Dx PERFORM study found successful daily data transmission from the ICM to LATITUDE Clarity™ Data Management System occurred 86% of the time.4* Other findings include:
  • Median percent of days with a data transmission for individual patients was 94%.4*​
  • 43 reprogramming sessions in 34 subjects.4*​
  • 36 reprogramming sessions in 24 patients were completed using the myLUX™ Patient App.4*​
  • 92% of the changes were applied within 48 hours.4*​

Timeline of publications and clinical trials

See a extensive list of the LUX-Dx ICM Systems publications and ongoing clinical trials.

Download the overview (PDF)​
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LUX-Dx II+ ICM Technical Specifications

Get additional information on product specs, battery longevity, system components and more.

LUX-Dx II™ and LUX-Dx II+™ Insertable Cardiac Monitor Systems Indications, safety, and warnings

* Evaluated using the LUX-Dx™ ICM System

1. Kamsani, S, Middeldorp, M, Evans, S. et al. Accuracy of Implantable Loop Recorders: Multicenter, Multidevice Comparison. J Am Coll Cardiol EP. Feb 2026, https://doi.org/10.1016/j.jacep.2025.12.039.

2. Frazier-Mills C, Raja A, Saleeby RC, et al. Consistent visibility of P-waves observed in patients implanted with LUX-Dx Insertable Cardiac Monitor (ICM). Heart Rhythm. 2021;18(8):S398. doi:10.1016/j.hrthm.2021.06.985

3. Richards M, Mahajan D, Simon T, et al. Interim evaluation of insertable cardiac monitor signal quality in the LUX-Dx PERFORM study. EP Europace. 2023;25:S1. doi:10.1093/europace/euad122.612

4. Stolen C, Rosman J, Manyam H, et al. Preliminary results from the LUX-Dx insertable cardiac monitor remote programming and performance (LUX-Dx PERFORM) study. Clinical Cardiology. 2023;46(1):100-107. doi: 10.1002/clc.23930