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Insertable cardiac monitor gains FDA approval
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Biotronik recently announced that the BioMonitor 2 insertable cardiac remote monitor with ProMRI technology was approved by the FDA.
The BioMonitor 2 device is designed to detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope, and can also be used to monitor atrial events in patients who have undergone ablation procedures, according to a press release.
The device is inserted subcutaneously via a minimally invasive procedure under local anesthesia and features a flexible antenna and positioning to adapt to a patient’s anatomy. Other features include ProMRI technology, which enables patients to undergo MRI scans as needed; more than 60 minutes of electrocardiogram recording time; and Intelligent Memory Management, according to the release.
Results of a recent pilot study conducted in Australia demonstrated greater than 90% transmission reliability for daily transmissions with the BioMonitor 2 device.
"Prevention is necessary, yet more than 35% of strokes are cryptogenic and occur with no known cause,” Mark Richards, MD, PhD, FACC, FHRS, with the Arrhythmia and Cryptogenic Stroke Programs, ProMedica Heart and Vascular Institute, said in a press release. “The fast and accurate detection of clinically relevant atrial arrhythmias in these patients is critical to administering therapy that minimizes risk of recurrent stroke.”
Disclosure: Richards reports consulting and serving on the speaker’s bureau for Biotronik.