Biomedical device company Biotronik has received approval with conditions from the U.S. Food and Drug Administration (FDA) for the company's ProMRI clinical trial via an investigational device exemption.
The trial is designed to evaluate the safety and efficacy of Biotronik's Entovis dual- and single-chamber pacemaker systems in patients undergoing MRI scans under predetermined conditions. The ultimate goal of the trial is to determine whether patients with these devices can safely undergo MRI, the company said.
Biotronik intends to recruit 245 individuals at 30 U.S. investigational centers who are implanted with Biotronik's cardiac devices that include ProMRI technology. The company has already initiated site recruitment.
These systems, which include Biotronik's current pacing leads, are already approved in the U.S.
