BIOTRONIK Unveils New BIOMONITOR IV Insertable Cardiac Monitor

BIOTRONIK has received CE Mark approval for and completed the first European implant of its latest insertable cardiac monitor (ICM), BIOMONITOR IV, which features artificial intelligence (AI) for false positive reduction. The company touts BIOMONITOR IV as the only ICM on the market with premature ventricular and atrial contraction (PVC and PAC) discrimination capabilities,^1,2 as well as industry-leading signal quality and transmission success for highly reliable remote patient management.³
 
False positive detections may take clinicians a considerable amount of time to review. Consequently, BIOMONITOR IV features SmartECG, an intelligent system powered by AI and advanced algorithms to reduce false positive detections for atrial fibrillation (AF), bradycardia, tachycardia, and pause.^4,5 SmartECG reduces 86% of false detections across all major arrhythmias while keeping 98% of the clinically relevant episodes.⁶
 
“BIOMONITOR IV enables me to distinguish between PVC and PACs and clearly report burden over time. The new AI-based algorithm and the Quick View report offer me easy and efficient review, dedicate more time to my patients and their personalized treatment,” said Prof. Gerardo Nigro, head of the Electrophysiology Unit at “L. Vanvitelli” University of Naples, Monaldi Hospital, Italy, who implanted the first BIOMONITOR IV in Europe.
 
Compared to other ICMs on the market, BIOMONITOR IV offers significant workflow enhancements through increased automaticity, intuitive templates and reports, along with providing valuable clinical insights.^1-7 Clinical evidence, such as from a recent publication by Bisignani et al. demonstrates a meaningful workload reduction through SmartECG, resulting in up to 42% reduced time spent for episode reviews.⁷ The improvements in BIOMONITOR IV with SmartECG are based on advanced algorithms together with BIOTRONIK’s experience, all incorporated in a fully explainable machine learning system for false AF filtering.
 
“AI and connected cardiac solutions have the potential to revolutionize healthcare. Our latest innovation, BIOMONITOR IV, will propel the field of cardiac monitoring in this new direction. BIOTRONIK was the first company to introduce remote care of cardiac rhythm devices over 20 years ago. Today, we will lead a new direction in intelligent systems that streamlines clinicians’ workflow and turns an industry overwhelmed with data into personalized and actionable care,” said Dr. Andreas Hecker, president CRM/EP at BIOTRONIK.
 
BIOTRONIK is a global medical technology company with products and services designed to treat heart and blood vessel diseases as well as chronic pain. The company is headquartered in Berlin, Germany, and is represented in more than 100 countries.
 
References
¹ Dukes et al., Novel PVC detection algorithm in an implantable cardiac monitor for longitudinal risk monitoring. Presented at ESC Congress 2023, August 25-27; Amsterdam, Netherlands.
² Marmerstein, Joseph, et al. Evaluation of a Novel PVC and PAC Detection Algorithm in an Implantable Cardiac Monitor for Longitudinal Risk Monitoring. Heart Rhythm O2, Aug. 2023.
³ 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.
⁴ Kapur et al., AI/machine learning AF algorithm improves clinical workflow in ICM. Presented at 16th Asia Pacific Heart Rhythm Society Scientific Session in Conjunction with CardioRhythm (APHRS 2023), 31 August – 3 September, Hong Kong.
⁵ Iwai et al., Novel automated overread strategy significantly improves clinical workflow in ICM remote monitoring. Presented at 16th Asia Pacific Heart Rhythm Society Scientific Session in Conjunction with CardioRhythm (APHRS 2023), 31 August – 3 September, Hong Kong.
⁶ SmartECG AF filtering programmed to Very Specific. Sensitivity and specificity depend on the programmed SmartECG filter configuration. Data on file 2023.
⁷ Bisignani et al., Implantable cardiac monitors: Artificial intelligence and signal processing reduce remote ECG review workload and preserve arrhythmia detection sensitivity. Frontiers in Cardiovascular Medicine. Volume 11 – 2024. doi: 10.3389/fcvm.2024.1343424.