Biotronik gets FDA approval for its BioMonitor 2 insertable cardiac monitor



Biotronik has announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI technology.

BioMonitor 2 is designed to provide physicians with the ability to accurately 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.

“The clinical and economic burdens of stroke are high and continue to grow. Prevention is necessary, yet more than 35% of strokes are cryptogenic and occur with no known cause,” says Mark Richards, Arrhythmia and Cryptogenic Stroke Programs, Promedica Heart & Vascular Institute. “The fast and accurate detection of clinically relevant atrial arrhythmias in these patients is critical to administering therapy that minimises risk of recurrent stroke. New diagnostic technologies, such as those found in the BioMonitor 2, can help manage these high-risk patients more effectively and efficiently.”

A recent Australian pilot study showed greater than 90% transmission reliability for daily Biotronik Home Monitoring transmissions, exceeding proven patient compliance. In addition, BioMonitor 2 has a capacity of more than 60 minutes of electrocardiogram (ECG) recording time and Intelligent Memory Management ensuring that the most relevant events are always available for review. BioMonitor 2 can transmit up to six subcutaneous ECGs daily via Biotronik Home Monitoring.

BioMonitor 2 is inserted subcutaneously through a minimally invasive process under local anaesthesia. The device provides a flexible antenna and positioning, adapting easily to a patient’s anatomy, while providing unmatched sensing amplitude that ensures reporting accuracy. BioMonitor 2 also features ProMRI technology, ensuring patients have access to full-body magnetic resonance imaging (MRI) scans (both 1.5T and 3.0T) as needed throughout their lifetime.