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 making effective diagnosis more difficult.

BIOMONITOR IIIm provides answers to both of these issues. Minimizing unnecessary work by significantly reducing AF false positives1, and maximizing precision by consistently delivering clear, high definition ECGs. Helping physicians focus on the things that really matter.

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Injection Procedure in Less Than One Minute2

No need for unnecessarily complicated delivery tool assemblies. Eradicates time consuming and potentially costly multi-step procedures.

 


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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 fibrillation.

  • RhythmCheck eliminates 72% of false positive AF detections of patients with ectopic beats1
  • 52% of false positive detections are due to ectopic beats7
  • 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 evaluation
  • 89% mean P-wave visibility in sinus rhythm heart cycles delivers proven high quality signals3
  • High and stable 0.7 mV R-wave amplitude sensing allows for optimal arrhythmia detection3
  • Sensing is 99% noise free, helping maximize effective monitoring3
  • Precise calculation of AF burden includes episodes as short as 30 seconds
  • AF Episode sensitivity of the BIOMONITOR IIIm (without the RhythmCheck  algorithm) is 99.1%6
  • BIOMONITOR IIIm sensitivity for High Ventricular Rate, Brady, Asytoly and Sudden Rate Drop episodes is 100%5
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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.

  • 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 seconds2
  • Fully automated, zero set-up Home Monitoring provides an industry-leading transmission compliance rate of 98%3
  • Also industry leading is 5.5 years longevity, particularly valuable for patient groups that benefit from extended monitoring
  • A unique Ectopy Counter provides count and trend data for the last 240 days – a potential marker for HF, AF, and stroke risk
  • An optional Patient App with a Home Monitoring synchronized symptom diary facilitates fast evaluation of rhythm-symptom correlations

1. Performance of BIOMONITOR IIIm Ectopy Rejection Parameter in Patients with Ectopy. BIOTRONIK Data on File
2. BIO|CONCEPT.BIOMONITOR III. BIOTRONIK Data on file
3. Lovibond S et al. “The BIO|CONCEPT.BIOMONITOR III study: Sensing performance and Home Monitoring transmission success of a new miniaturized ICM.” Presented at the 12th APHRS Scientific Session. Bangkok, Thailand. 24-27
4. BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment (BioInsight); final study report; data on file.
5. Piorkowski C, et al. Pacing and clinical electrophysiology : PACE. 2019
6. 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.
7. Afzal. Et al. Incidence of false-positive transmissions during remote rhythm monitoring with implantable loop recorders. Heart Rhythm 2020;17:75–80)
8. 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.