Biotronik has enrolled first patients in the BioInsight clinical study of its BioMonitor 2 heart monitor, which looks to evaluate the feasibility of in-office procedure.
The study will assess time and resources in comparison to traditional hospital settings.
Participants of the study will receive BioMonitor 2 through an in-office insertion and will be analysed for 90 days for any potential adverse effects such as infection or bleeding.
BioMonitor 2 is an insertable remote cardiac monitor based on ProMRI technology.
The device will be placed underneath the skin of a patient and it will help physicians to detect and diagnose atrial fibrillation and syncope.
Atrial fibrillation, according to Biotronik is one of the leading causes of stroke and heart failure. The company claims that BioMonitor 2 offers the highest signal amplitude that leads to high sensitivity for improved reporting accuracy.
The device can also be used for monitoring patients with atrial fibrillation and who have undergone ablation procedures. Since, the device received an approval from the USFDA in April this year, about 2000 devices have been sold.
Biotronik president Marlou Janssen said: "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."
Image: Biotronik starts study to validate in-office insertion of BioMonitor 2. Photo: Courtesy of PRNewsFoto/BIOTRONIK.