BIOTRONIK‘s new BioMonitor 2 implantable continuous wireless cardiac monitor won regulatory approval in the European Union. The device is intended to keep a close eye on patients with atrial fibrillation, bradycardia, tachycardia, and syncopal episodes while they’re ambulatory and out of the clinic.
The device is implanted within about two minutes under the skin and begins recording anytime there are unusual rhythms. It has a recording time of 60 minutes and will automatically upload the ECGs to a cardiologist’s online portal via BIOTRONIK’s Home Monitoring system.
The pilot 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.”