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 car...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Clinical Trials Patient Monitoring Biotronik Source Type: news