Biotronik begins study assessing in-office insertion of BioMonitor 2

Biotronik has announced that the first patients have been enrolled for a new study assessing the in-office use of its BioMonitor 2 cardiac monitor.

The BioInsight clinical study aims to evaluate the safety and feasibility of performing the minimally invasive BioMonitor 2 insertion procedure in an office setting – an option that would be quicker and cheaper for patients and physicians alike.

Participants will receive BioMonitor 2 via in-office insertion and will be evaluated for 90 days to monitor for any potential adverse events, including infection and bleeding. The study is expected to be completed in the third quarter of 2017.

Marlou Janssen, president of Biotronik, said: "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."

The cardiac remote monitor comes equipped with ProMRI technology and is placed underneath the skin to help physicians accurately detect and diagnose atrial fibrillation and syncope.

BioMonitor 2 provides the highest signal amplitude on the market, leading to excellent sensitivity for improved reporting accuracy. More than 2,000 devices have been sold since it was approved in the US in April 2016.

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