- Biotronik received CE approval for its BioMonitor 2 implantable continuous wireless cardiac monitor
- The device is designed for reliable long-term continuous remote monitoring of patients with atrial fibrillation
- A study showed the reliability of the unique, subcutaneous, insertable cardiac monitor
- Biotronik is headquartered in Berlin, Germany and represented in over 100 countries
- The cardiac monitor will be available on the European market soon
Biotronik, a leading manufacturer of cardio- and endovascular medical technology, has received CE approval for its BioMonitor 2 implantable continuous wireless cardiac monitor.
The device is designed for highly accurate and reliable long-term continuous remote monitoring of patients with atrial fibrillation – an abnormal heart rhythm characterized by rapid and irregular beating, syncope – a short loss of consciousness and muscle strength, bradycardia – abnormally slow heart action, and Tachycardia – abnormally rapid heart rate.
The company in a press release said that the results of a pilot study into the performance of BioMonitor 2 showed the reliability of the unique, subcutaneous, insertable cardiac monitor.
The study involved patients in Australia. BioMonitor 2 can provide an insertion time of fewer than two minutes, high R-Wave amplitudes and a greater than 90 percent 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 sECGs daily via home monitoring.
Dr. Sze-Yuan Ooi, Prince of Wales Hospital, Sydney, Australia, said that the results of the BioMonitor 2 study confirmed 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,” Dr. Ooi said.
Manuel Ortega, Senior Vice President at BIOTRONIK said that, “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.It’s 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 Home Monitoring
Biotronik Monitoring transmits patient heart data automatically on a daily basis, thereby rapidly detecting deterioration in a patient’s clinical status. Early detection of clinically relevant events, in particular paroxysmal and asymptomatic arrhythmias such as atrial fibrillation, enables the physician to adapt patient therapy at a very early stage. Home monitoring supported follow-up also helps to lower costs and streamline workflow.
Biotronik is headquartered in Berlin, Germany and represented in over 100 countries with more than 5,600 employees. Several million patients have received Biotronik implants designed to save and improve the quality of their lives or have been treated with Biotronik coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Biotronik home monitoring; the world’s first 4 F-compatible 200 mm peripheral stent; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI technology.