News | Implantable Cardiac Monitor (ICM) | December 22, 2020

FDA Clears Fever-Detecting Cardiac Monitor From Biotronik

With the FDA clearance of the Vital Data Sensor, Biotronik's Biomonitor IIIm features two-in-one detection, providing physicians the ability to monitor for early signs of potential life-threatening cardiac arrhythmias and body temperature increases potentially associated with fever.

With the FDA clearance of the Vital Data Sensor, Biotronik's Biomonitor IIIm features two-in-one detection, providing physicians the ability to monitor for early signs of potential life-threatening cardiac arrhythmias and body temperature increases potentially associated with fever.


December 22, 2020 — The U.S. Food and Drug Administration (FDA) cleared Biotronik's Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new Biomonitor IIIm injectable cardiac monitor (ICM). 

The fever monitoring technology was recently discussed in an article in the journal Heart Rhythm Case Reports.[1]

Physicians will now have access to daily reports on vital data, including body temperature, and cardiac arrhythmia data to help them monitor patient health and their treatment remotely. Biomonitor IIIm contains integrated sensor technologies designed to measure patient activity, heart rate and body temperature. The interrelationship between these vital signs and health conditions is well-documented, particularly fever, which leads to increases in mean and resting heart rates and possible decreases in activity levels.[2]

The first U.S. case using Biomonitor IIIm was performed by Luigi Di Biase, M.D., Ph.D. "The patient is at high risk for infection during this global pandemic due to underlying conditions. It is comforting for me and my patients knowing that we will be able to monitor for early signs of potential life-threatening cardiac arrhythmias and infections for up to 5.5 years. Coupled with the workflow advantages, this device is a step forward for injectable cardiac monitors," said Di Biase, who is the section head of electrophysiology and director of arrhythmia services at Montefiore Health System in New York City.

This exclusive integrated sensor in Biomonitor IIIm enables physicians to stay connected with cardiac patients and proactively monitor them for warning signs at home — preserving capacity in hospitals for the sickest patients. This meaningful digital health innovation can potentially provide earlier detection while helping to streamline remote patient management.

"Vital data trends help support the diagnosis for a range of illnesses and, given the additional impact of the current pandemic on cardiac health, we have worked with urgency to advance Biomonitor IIIm's unique sensor technology," said Dr. David Hayes, chief medical officer of Biotronik Inc. "Patients with cardiac conditions are at an increased risk for worse outcomes from many systemic illnesses, so closer monitoring of these patients may help manage potential symptoms associated with a febrile response, particularly if it can be done safely and remotely."

In addition to these benefits, Biomonitor IIIm is the industry leader in battery longevity with 5.5 years of continuous monitoring, providing long-term monitoring of chronic cardiac conditions.  Biomonitor devices have a unique design which facilitates a one-step injection procedure, delivers class-leading detection performance, and signal fidelity comparable to gold-standard 12-lead ECG recordings. In addition, the proven performance of Biotronik Home Monitoring ensures 98 percent daily transmission success for streamlined clinical device management.[3]

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FDA Clears Boston Scientific LUX-Dx Insertable Cardiac Monitor

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References:

1. Whittington RH et al. Temperature monitoring with an implantable loop recorder in a patient with presumed COVID-19. Heart Rhythm Case Reports. 2020, 6(8). https://www.heartrhythmcasereports.com/article/S2214-0271(20)30113-5/pdf

2. Jensen MM, Brabrand M. The relationship between body temperature, heart rate and respiratory rate in acute patients at admission to a medical care unit. Scand J Trauma Resusc Emerg Med 23, A12 (2015). https://doi.org/10.1186/1757-7241-23-S1-A12.

3. Mariani JA, 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.

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