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Home Industry News Biotronik receives CE Mark approval for Biomonitor 2 cardiac monitor

Biotronik receives CE Mark approval for Biomonitor 2 cardiac monitor

28th August 2015

Biotronik has been granted European CE Mark approval for BioMonitor 2, its unique new subcutaneous insertable cardiac monitor.

The device has been designed for highly accurate and reliable long-term continuous remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachycardia.

Results from a new pilot study of the device have been shared just ahead of the 2015 European Society of Cardiology Congress in London, showing it can provide an insertion time of less than two minutes, high R-Wave amplitudes and a success rate for daily Home Monitoring transmissions of greater than 90 percent.

It also has a capacity of more than 60 minutes of electrocardiogram (ECG) recording time and can transmit up to six subcutaneous ECGs daily via Home Monitoring.

Manuel Ortega, senior vice-president at Biotronik, said: "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."

This comes after the firm recently launched BioCONTINUE, a study that will evaluate the relevance of defibrillator backups following the replacement of a cardiac resynchronisation therapy defibrillator.ADNFCR-8000103-ID-801799125-ADNFCR

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