First generation LUX-Dx™ ICM System demonstrated highest overall PPV1
Alert-level PPV across arrythmia types and device manufactures
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An independent abstract presented at HRS 2024 evaluated real-world arrhythmia detection accuracy across all insertable cardiac monitor (ICM) manufacturers. A total of 652 patients with 18,665 alerts were randomly selected across multiple centers and analyzed for rates of true and false positive transmissions. They found the first-generation LUX-Dx ICM Systems had the highest overall Positive Predictive Value (PPV) across all ICMs evaluated.
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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 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
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 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*
Clinical compendium
Get access to detailed information on our publications, including methods, results, and LUX-Dx systems clinical trials.
Timeline of publications and clinical trials
See a extensive list of the LUX-Dx ICM Systems publications and ongoing clinical trials.
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* Evaluated using the LUX-Dx™ ICM System
1. Kamsani S, Middeldorp M, Evans S, et al. Accuracy of Implantable Loop Recorders: A Multi-Centre, Multi-Device Comparison of False Positive Alert Burden in Remote Transmissions. Heart Rhythm Journal. 2024;21(5):PO-01-021. Doi: 10.1016/j.hrthm.2024.03.635
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