BIOMONITOR IV

BIOMONITOR IV with SmartECG

Intelligence. Confidence. Clarity.

A real challenge exists in the clinical world today with the volume of data gathered, as more patients benefit from the proven value of long-term ICM monitoring. Precious time and resources are spent analyzing false positive arrhythmias, leaving patients waiting for accurate answers. BIOMONITOR IV can help. With artificial intelligence (for AF detection) and advanced detection algorithms, false positives are reduced by 86% across all major arrhythimas1. BIOMONITOR IV alleviates the review burden and helps clinicians achieve timely and accurate diagnosis to help focus on what's most important - the patient.



Intelligence with SmartECG

A significant challenge exists for clinicians with the volume of data gathered as more patients benefit from long-term ICM monitoring. BIOMONITOR IV comes with SmartECG, an intelligent system that powers AI and advanced algorithms, to reduce the number of false positive episodes for Atrial Fibrillation, Bradycardia, Tachycardia, and Pause. This allows you to focus on actionable events and spend more time on patient care.

  • SmartECG reduces 86% of false detections across all major arrhythmias while keeping 98% of the clinically relevant episodes.1
  • SmartECG is supported by AI for AF detection to reduce false positive and improve workflow efficiency.


Confidence from BIOTRONIK Home Monitoring

When it comes to system set-up, the BIOMONITOR IV with BIOTRONIK Home Monitoring offers indication-based templates, enhanced automaticity and intuitive reports to deliver efficient access to optimized clinical data and insights. BIOTRONIK Home Monitoring delivers on the promise of improving patient outcomes and driving operational efficiency.

  • Industry leading, 98% daily transmission reliability2
  • On-Demand transmissions for symptomatic episodes
  • New Quick View report for easy and efficient review

Clarity with PVC/PAC Discrimination

BIOTRONIK’s BIOMONITOR IV is the industry’s first to offer the capability to discriminate premature atrial and ventricular contractions (PACs and PVCs) and clearly report burden over time. BIOMONITOR IV brings a new level of intelligence to achieve accurate risk stratification based on the PAC and PVC burden and the related therapy strategy.

  • High frequency of PACs and PVCs is associated with the development of AF, and with an increased risk of stroke, heart failure, and death3,4,5
  • High PVC burden increases the risk of the combined endpoint of all-cause mortality, cardiovascular mortality, SCD, or development of ischemic heart disease5
  • High PVC burden is associated with 3-fold greater odds for LVEF decline (after 5 years), a 48% increased risk of incident CHF (after 13 years), and a 31% increased risk of death (after 15 years)6

1 Data on file. With AF filtering criterion set to Very specific in the Home Monitoring Service Center. Sensitivity is relative to performance without SmartECG.
2 Mariani JA, Weerasooriya R, van den Brink O, Mohamed U, Gould PA, Pathak RK, et al. Miniaturized implantable cardiac monitor with a long sensing vector (BIOMONITOR III): Insertion procedure assessment, sensing performance, and home monitoring transmission success. J Electrocardiol. 2020;60:118–25. doi: 10.1016/j.jelectrocard.2020.04.004.
3 Binici Z, Intzilakis T, Nielsen OW, Køber L, Sajadieh A. Excessive supraventricular ectopic activity and increased risk of atrial fibrillation and stroke. Circulation. 2010;121(17):1904–11. doi: 10.1161/CIRCULATIONAHA.109.874982.
4 Larsen BS, Kumarathurai P, Falkenberg J, Nielsen OW, Sajadieh A. Excessive Atrial Ectopy and Short Atrial Runs Increase the Risk of Stroke Beyond Incident Atrial Fibrillation. J Am Coll Cardiol. 2015;66(3):232–41. doi: 10.1016/j.jacc.2015.05.018.
5 Todo K, Iwata T, Doijiri R, Yamagami H, Morimoto M, Hashimoto T, et al. Frequent Premature Atrial Contractions in Cryptogenic Stroke Predict Atrial Fibrillation Detection with Insertable Cardiac Monitoring. Cerebrovasc Dis. 2020:1–7. doi: 10.1159/000505958. PubMed PMID: 32023609.
6 Dukes JW, Dewland TA, Vittinghoff E, Mandyam MC, Heckbert SR, Siscovick DS, et al. Ventricular Ectopy as a Predictor of Heart Failure and Death. J Am Coll Cardiol. 2015;66(2):101–9. doi: 10.1016/j.jacc.2015.04.062.

 

 

Indications for use: The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias:

  • Atrial fibrillation
  • Bradycardia
  • Sudden Rate Drop
  • Tachycardia
  • Pause

Contraindications: There are no known contraindications for the insertion of the BIOMONITOR device. 

Warnings and Precautions: Reference applicable technical manuals for detailed information about other devices used with the BIOMONITOR device. 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 device 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.