BIOTRONIK won FDA clearance for the Vital Data Sensor, a body temperature component within the BIOMONITOR IIIm injectable cardiac monitor (ICM). The ICM is designed to help cardiologists detect and diagnose cardiac arrhythmias remotely, but thanks to the Vital Data Sensor the implant now has an additional role in monitoring for signs of fever. This is particularly important right now as the COVID-19 pandemic lingers on, but will remain a useful patient monitoring tool even when the current virus recedes.
“The patient is at high risk for infection during this global pandemic due to underlying conditions,” said Dr. Di Biase, section head of Electrophysiology, Director of Arrhythmia Services at Montefiore Health System, in a BIOTRONIK press release. “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.”
Given that patients with existing cardiac conditions are at a greater risk for poor COVID-19 outcomes, closely monitoring them for the earliest signs of infection should help improve outcomes. Moreover, the technology can help keep such patients away from hospitals when there’s no need for them to come in, avoiding unnecessary in-person contacts and keeping the healthcare system focused on those with the greatest needs.
“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,” added 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.”
Here’s a quick animation showing how the device is implanted:
Product page: BIOMONITOR IIIm
Flashbacks: BIOTRONIK Releases BIOMONITOR III Injectable Cardiac Monitor; BIOMONITOR III Injectable Cardiac Monitor Wins FDA Clearance; BIOTRONIK BioMonitor 2 Wireless Implantable ECG Recorder FDA Approved; BIOTRONIK BioMonitor Implant Keeps a Close Eye on Heart Rhythms; BIOTRONIK Releases BioMonitor 2 Wireless Subcutaneous ECG System; BIOTRONIK’s BioMonitor 2 Implantable Wireless ECG Recorder Approved in Europe