ESC Congress 2015: BIOTRONIK Announces CE Approval and Pilot Study Results for BioMonitor 2

First Results for Thinner, Lighter Insertable Cardiac Monitor show High Performance in Sensing, Detection and Home Monitoring Transmission.

BERLIN, Germany, August 27, 2015 — BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, today announced CE approval and the results of a pilot study into the performance of BioMonitor 2. The findings, being shared just ahead of the 2015 ESC Congress in London, showcase the reliability of the unique, subcutaneous, insertable cardiac monitor.

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.”

BioMonitor 2 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.”

    About BIOTRONIK:

    At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular and endovascular solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.