Biotronik announced Dec. 5 that the first patients had enrolled in the BioInsight trial, which is evaluating the use of the BioMonitor 2 in an office setting.
In April, the FDA approved the BioMonitor 2, which is a cardiac remote monitor with ProMRI technology that is inserted beneath the skin and used to detect and diagnose atrial fibrillation and syncope. Since the approval, more than 2,000 BioMonitor 2 devices have been sold in the U.S., according to the company.
During the BioInsight study, the researchers expect to enroll 75 patients who are indicated for continuous arrhythmia monitoring. Patients will receive the BioMonitor 2 device in the office and be monitored for 90 days for any signs of infection, bleeding or other adverse events.
Biotronik expects to complete the study in the third quarter of 2017.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.