Biotronik announces CE mark approval and pilot study results for BioMonitor 2

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Biotronik has announced CE mark approval and the results of a pilot study into the performance of the subcutaneous, insertable cardiac monitor BioMonitor 2.

BioMonitor 2 is designed for highly accurate and reliable long-term continuous remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachycardia.

The company announced that 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% 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,” comments 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.”


“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,” says Manuel Ortega, senior vice president at Biotronik. “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.

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