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    BIOMONITOR IIIm

BIOMONITOR IIIm

Maximized Precision. Minimized Workload.

Physicians working with ICMs generally have a very heavy workload  and false positive AF detections just add to this, as well as making effective diagnosis more difficult.1

BIOMONITOR IIIm provides answers to both of these issues. Minimizing unnecessary work by significantly reducing AF false positives2, and maximizing precision by consistently delivering clear, high definition ECGs. Helping physicians focus on the things that really matter.3
 

Category

Insertable Cardiac Monitor Arrhythmia Monitoring Remote Patient Monitoring

Product Highlights

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Minimized workload

Minimized Workload

With its breakthrough RhythmCheck algorithm, BIOMONITOR IIIm greatly reduces time-consuming ECG reviews of episodes falsely detected as atrial fibrillation2

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Maximized Precision

Maximized Precision

BIOMONITOR IIIm delivers clinically actionable high-definition ECGs4

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Patient centered monitoring experience

Patient-Centered Monitoring Experience

From injection to diagnosis, BIOMONITOR IIIm enhances workflow efficiency in every step  of delivering a timely and accurate diagnosis

Minimized Workload

With its breakthrough RhythmCheck algorithm, BIOMONITOR IIIm greatly reduces time-consuming ECG reviews of episodes falsely detected as atrial fibrillation.

  • RhythmCheck eliminates 78% of false positive AF detections of patients with ectopic beats11
  • 52% of false positive detections are due to ectopic beats10
  • RhythmCheck recognizes every single ectopic beat and avoids them being misinterpreted as atrial fibrillation
  • For maximum precision, the intelligent RhythmCheck algorithm dynamically adjusts to each patient’s unique rhythm

Maximized Precision

BIOMONITOR IIIm delivers clinically actionable high-definition ECGs.

  • The unique BIOvector design provides high signal quality for fast and confident ECG evaluation7
  • 95.1% mean P-wave visibility in sinus rhythm heart cycles delivers proven high quality signals4
  • High and stable 0.7 mV R-wave amplitude sensing allows for optimal arrhythmia detection3
  • Sensing is 99% noise free,* helping maximize effective monitoring7
  • Precise calculation of AF burden includes episodes as short as 30 seconds12
  • AF Episode sensitivity of the BIOMONITOR IIIm (without the RhythmCheck  algorithm) is 99.1%9
  • BIOMONITOR IIIm sensitivity for High Ventricular Rate, Brady, Asystole and Sudden Rate Drop episodes is 100%8

Patient-Centered Monitoring Experience

From injection to diagnosis, BIOMONITOR IIIm enhances workflow efficiency in every step  of delivering a timely and accurate diagnosis.

  • One-Step Injection with a preloaded ICM makes it ideally suitable for in-office procedures
  • During the One-Step Injection, the median time from incision to tool removal was 39 seconds7
  • Fully automated, zero set-up Home Monitoring provides an industry-leading transmission compliance rate of 98%7
  • Also industry-leading is 5.5 years longevity,13 particularly valuable for patient groups that benefit from extended monitoring
  • A unique Ectopy Counter provides count and trend data for the last 240 days13 — a potential marker for HF, AF, and stroke risk
  • MRI scanning can be performed without any waiting period after injection, as the device is 1.5T and 3.0T full-body MR conditional13

Media

BIOMONITOR IIIm
Video
BIOMONITOR IIIm Injection Animation

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References

*The proportion of a 24-hour period, during which very fast signals (<180 ms) prevent the evaluation of the rhythm

1) Seiler A, Biundo E, Di Bacco M, et al. Clinic Time Required for Remote and In-Person Management of Patients With Cardiac Devices: Time and Motion Workflow Evaluation. JMIR Cardio. 2021;5(2):e27720. Published 2021 Oct 15. doi:10.2196/27720 2) Bisignani G, Cheung JW, Rordorf R, et al. Implantable cardiac monitors: artificial intelligence and signal processing reduce remote ECG review workload and preserve arrhythmia detection sensitivity. Front Cardiovasc Med. 2024;11:1343424. Published 2024 Jan 23. doi:10.3389/fcvm.2024.1343424 3) McDowall L et al. The BIO|CONCEPT.BIOMONITOR III study: Performance of implanted BIOMONITOR IIITM for detection of baseline electrocardiogram (ECG) parameters. Poster AP19-01240; APHRS 2019 4) Deneke T, Cabanas P, Hofer D, et al. New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population. Heart Rhythm O2. 2022;3(2):152-159. Published 2022 Jan 30. doi:10.1016/j.hroo.2022.01.010  5) Performance of BIOMONITOR IIIm Ectopy Rejection Parameter in Patients with Ectopy. BIOTRONIK Data on File; 6) BIO|CONCEPT.BIOMONITOR III. BIOTRONIK Data on file; 7) Mariani JA et al. J Electrocardiol. 2020, 60.;  8) Piorkowski C, et al. Pacing and clinical electrophysiology : PACE. 2019; 9) BIOTRONIK AF Detect Analysis data on file 2019. PPV and sensitivity from analysis of BIOMONITOR III algorithm in patients with known AF from BIOTRONIK AF Detect study; 10) Afzal. Et al. Incidence of false-positive transmissions during remote rhythm monitoring with implantable loop recorders. Heart Rhythm 2020;17:75–80; 11) Assaf A, Theuns DAMJ, Sakhi R, Bhagwandien RE, Szili-Torok T, Yap SC. Accuracy of atrial fibrillation detection by an insertable cardiac monitor in patients undergoing catheter ablation: Results of the BioVAD study. Ann Noninvasive Electrocardiol. 2022;27(3):e12960. doi:10.1111/anec.12960; 12) Schreiber T, Cretnik A, Schauerte P, et al. P-wave detection performance of the BioMonitor III, Confirm Rx and Reveal Linq implantable loop recorders. J Electrocardiol. 2022;71:62-66. doi:10.1016/j.jelectrocard.2022.01.005; 13) BIOTRONIK. BIOMONITOR IIIm Technical Manual. MN093r1 12/10/20