Biotronik, a leading manufacturer of cardio- and endovascular medical technology, has received CE approval for its BioMonitor 2 implantable continuous wireless cardiac monitor.
According to the company, the results of a pilot study into the performance of BioMnitor 2 show the reliability of the unique, subcutaneous, insertable cardiac monitor.
The study demonstrated that monitor 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.
Also, the device has a capacity of over 60 minutes of ECG recording time and can transmit up to six 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.
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," said Dr. Sze-Yuan Ooi, Prince of Wales Hospital, Sydney, Australia.
The device is designed for highly accurate and reliable long-term continuous remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachycardia.
"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," commented 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."