The FDA approved the ProMRI implantable cardioverter defibrillator (ICD) systems for use with full-body MRI scans on Dec. 22.
The approval includes the Iperia DR-T in the DF-1 and DF-4 configurations, the Iperia DX System and the Inventra ProMRI DX, according to a news release from Biotronik, the devices’ manufacturer. The company cited research that found 75 percent of patients with an ICD or pacemaker will need an MRI scan during their lives.
Biotronik said this is the third FDA approval in the past 18 months for its ProMRI technology, which allows patients with approved pacemakers, implantable defibrillators or cardiac monitors to have 1.5 Tesla MRI scans without an exclusion zone.
“Our goal is to integrate ProMRI technology across our entire line of implantable systems, and in doing so, provide access to MRI diagnostic scans for all [cardiac rhythm management] patients,” Biotronik President Marlou Janssen said in a news release.