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.
Injection Procedure in Less Than One Minute2
No need for unnecessarily complicated delivery tool assemblies. Eradicates time consuming and potentially costly multi-step procedures.
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
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. 3 Mariani JA et al. J Electrocardiol. 2020, 60.
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)
Indications for use: The BIOMONITOR III/IIIm are indicated to detect the following cardiac arrhythmias: atrial fibrillation, bradycardia, sudden rate drop, high ventricular rate (HVR) and asystole. The BIOMONITOR III/IIIm is indicated for patients with clinical syndromes or situations at increased risk of cardiac arrhythmias; patients who experience transient symptoms that may suggest a cardiac arrhythmia. The device has not been tested for and it is not intended for pediatric use.
Contraindications: There are no known contraindications for the insertion of the BIOMONITOR III/IIIm.
Warnings and Precautions: Reference applicable technical manuals for detailed information about other devices used with the BIOMONITOR III/IIIm. Certain therapeutic and diagnostic procedures may cause undetected damage to an insertable cardiac monitor (ICM), resulting in malfunction or failure at a later time. Please note the following warnings and precautions:
MR Conditional - The cardiac monitor is labeled as MR conditional. Conditions for MR scans of the BIOMONITOR III/IIIm are located in the appropriate technical manual.
Storage (temperature) - Recommended storage temperature range is -10° to 45°C (14°-113°F). Exposure to temperatures outside this range may result in insertable cardiac monitor malfunction.
FOR SINGLE USE ONLY - Do not resterilize the insertable cardiac monitor, incision tool or insertion tool; they are intended for one-time use.
Use Before Date - Do not implant the device after the USE BEFORE DATE because the device sterility and longevity may be compromised.
Sharp - Packaging includes an incision tool that is sharp and should be handled with care.
For additional information see instructions for use at manuals.biotronik.com.