BIOTRONIK Wins FDA Clearance for its Vital Data Sensor in BIOMONITOR IIIm ICM

Biotronik FDA clearance for BIOMONITOR IIIm ICM
Biotronik

German biomedical company BIOTRONIK has won FDA clearance for the Vital Data Sensor, a body temperature component within the BIOMONITOR IIIm injectable cardiac monitor (ICM).

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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, reports Biotronik.

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 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.

An injectable cardiac monitor
Biotronik

“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.”

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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 that 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.