Biomedical device company Biotronik announced that the first U.S. patients have received its Iforia implantable cardioverter-defibrillators (ICDs).
The ICDs were put into use soon after the company received U.S. Food and Drug Administration (FDA) approval for a new phase of its ongoing ProMRI trial. The new phase is investigating the safety of ICDs in the MRI environment, according to the firm.
The expansion phase of the ProMRI clinical study to include ICDs will involve recruiting and evaluating 172 patients at 35 U.S. investigational centers. It is designed to confirm the safety and efficacy of Biotronik's Iforia devices and Setrox and LinoxSmart leads during MRI scans. All of the devices in the study are commercially available but do not have FDA clearance for use during MRI scans, the company said.
