Biotronik launches BioMonitor 2 subcutaneous heart monitor trial

Biotronik said today it enrolled the 1st patients in the BioInsight clinical study of its BioMonitor 2 heart monitor, which looks to investigate the feasibility implanting the BioMonitor 2 in office settings.

The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.

“One of the benefits of BioMonitor 2 is the ease of the insertion procedure, which typically only takes a few minutes. In-office procedures can reduce patient’s and physician’s time, increase access to the device and reduce cost burdens for healthcare systems. Early insertion will likely also reduce the time needed for a conclusive diagnosis,” Dr. Raul Weiss of Ohio State University said in prepared remarks.

The company’s BioInsight study is a multi-center, prospective, non-randomized post-market study in which patients will be implanted with the BioMonitor 2 via an in-office procedure, and will be followed for 90 days to monitor possible adverse events, including infection and bleeding.

“BioMonitor 2 has been rapidly adopted by physicians, becoming a trusted, reliable solution to monitor for cardiac arrhythmias. There is a significant need for BioMonitor 2, and we want to ensure our physicians have the utmost confidence in their ability to deliver efficient patient care. The BioInsight study will assure physicians and patients that performing the insertion procedure in an office setting safely and effectively improves access to this critical diagnostic tool,” prez Marlou Janssen said in a press release.

Biotronik said it hopes to complete the trial in the 3rd quarter of 2017. The company won FDA clearance for the device in April, and won CE Mark approval in the European Union last August.

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