Vital Data Sensor in New Cardiac Monitor receives clearance from FDA

BIOTRONIK 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 report.

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.

Dr. Di Biase, Section Head of Electrophysiology, Director of Arrhythmia Services, Montefiore Health System said: “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.” 

Dr. David Hayes, Chief Medical Officer, BIOTRONIK Inc. said: “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. 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.”