Biotronik said yesterday it won CE Mark approval in the European Union for its BioMonitor 2 subcutaneous insertable cardiac monitor and released results of a pilot study of the device.
The device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said.
The Australian pilot study reported an average insertion time of less than 2 minutes with a 90% success rate in sending transmissions to Biotronik’s home monitoring system, according to Berlin-based Biotronik.
“The results of the BioMonitor 2 study confirm the deliverability of the device and the excellent sensing amplitudes afforded by the increased sensing vector length. I am hopeful that future trials will show that this translates into improved diagnostic abilities that will aid physicians in the treatment of their patients,” Dr. Sze-Yuan Ooi of Sydney, Australia’s Prince of Wales Hospital said in a press release.
The device is capable of over 60 minutes of electrocardiogram monitoring, according to Biotronik, and can send up to 6 ECG scans daily through the company’s home monitoring system.
“With BioMonitor 2 to be available on the European market soon, we are pleased to see results indicating that physicians will be able to care for their patients based on information that is both high quality and reliably transmitted. Its accurate sensing and detection, combined with its transmission success and data capacity will provide doctors with more useful information on a patient’s condition over time,” senior veep Manuel Ortega said in prepared remarks.
Earlier this month, Biotronik announced 2 new studies that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor.
A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said.
Another trial, the BioGuard MI1 study, will examine the effectiveness of Biotronik’s BioMonitor at reducing the likelihood of major adverse cardiovascular events in patients with relatively preserved ejection fraction who have experienced myocardial infarction.