FDA Approves Insertable Cardiac Monitor

Device provides data via remote home-monitoring transmissions

The FDA has approved BioMonitor 2 (Biotronik), an insertable cardiac remote monitor designed to provide physicians with the ability to detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who have undergone ablation procedures.

BioMonitor 2 is inserted subcutaneously through a minimally invasive procedure under local anesthesia. The device features ProMRI technology, which allows patients with a pacemaker, implantable defibrillator, cardiac monitor, or cardiac resynchronization therapy defibrillator (CRT-D) or pacemaker (CRT-P) to undergo magnetic resonance imaging (MRI) scans.

In an Australian pilot study, BioMonitor 2 offered greater than 90% transmission reliability for daily Biotronik Home Monitoring transmissions, exceeding proven patient compliance. Biotronik Home Monitoring is an internet-based, automatic remote-monitoring system that uses the cellular phone network to enable physicians to remotely monitor their patients’ clinical status and device status.

BioMonitor 2 has the capacity for more than 60 minutes of electrocardiogram (ECG) recording time. The device can transmit up to six subcutaneous ECGs daily via Biotrinik Home Monitoring.

Source: PR Newswire; April 12, 2016.