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Study launched to evaluate office-based procedure for insertion of cardiac monitor
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Biotronik announced that it has begun enrolling patients in the Biolnsight clinical study, which will evaluate the safety and feasibility of an office-based procedure for insertion of a cardiac monitor.
According to a press release, the monitor (BioMonitor 2), which is placed underneath the skin of a patient, assists physicians in diagnosing and detecting atrial fibrillation and syncope.
Additionally, the device can monitor AF in patients who have undergone procedures for ablation, the company stated.
“One of the benefits of BioMonitor 2 is the ease of the insertion procedure, which typically only takes a few minutes,” Raul Weiss, MD, FACC, cardiologist at The Ohio State University, said in the release. “In-office procedures can reduce patient’s and physician’s time, increase access to the device and reduce cost burdens for health care systems. Early insertion will likely also reduce the time needed for a conclusive diagnosis.”
The multicenter, prospective, nonrandomized postmarket study will evaluate patients who have received the BioMonitor 2 device in an office setting for 90 days for complications such as infection and bleeding, according to the release.
Disclosure: Weiss reports receiving consultant fees, speaker fees and research grants from Biosense Webster, Biotronik, Boston Scientific, Medtronic and St. Jude Medical.