BIOTRONIK announces CE approval, pilot study results for BioMonitor 2

BioMonitor 2

BIOTRONIK has scored CE approval for its BioMonitor 2, long-term continuous remote monitoring device of patients with atrial fibrillation, syncope, bradycardia and tachycardia. The approval will allow the company to launch the BioMonitor 2 on the European market soon.

Also, the company announced the results of a pilot study into the performance of BioMonitor 2. Said study, involving patients in Australia, showed that BioMonitor 2 can provide an insertion time of less than two minutes, high R-Wave amplitudes and a greater than 90 percent success rate for daily BIOTRONIK Home Monitoring transmissions. In addition, the device has a capacity of over 60 minutes of ECG recording time and can transmit up to six sECGs (subcutaneous ECG) daily via Home Monitoring.

“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,” commented Dr. Sze-Yuan Ooi, Prince of Wales Hospital, Sydney, Australia. “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.”