FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

LAKE OSWEGO, Ore., Dec. 16, 2020 /PRNewswire/ -- BIOTRONIK today announced FDA clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new BIOMONITOR IIIm injectable cardiac monitor (ICM), as shown in a published case report¹.

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 rates² and possible decreases in activity levels.

The first US case using BIOMONITOR IIIm was performed by Dr. Luigi Di Biase. "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 Dr. Di Biase, section head of Electrophysiology, Director of Arrhythmia Services at Montefiore Health System.

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

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.

About BIOTRONIK:
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.

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SOURCE BIOTRONIK