The FDA approved the Evera MRI Surescan implantable cardioverter defibrillator (ICD) as the first ICD system for use with MRI scans.
The Evera MRI ICD system (Medtronic) is intended for patients with sudden cardiac arrest. The system, which is expected to be available this month, includes the Evera MCI ICD and the Sprint Quattro Secure MRI SureScan DF4 leads.
Previous ICD systems were contraindicated with MRI scans because their interaction may lead to risks for patients. However, the Evera MRI ICD system allows patients to safely undergo full-body MRI scans.
The approval was based on results of a multicenter, prospective, randomized clinical trial. Results were presented the at the Heart Rhythm Society’s scientific session in May and simultaneously published in the Journal of the American College of Cardiology.
Between April and September 2014, researchers enrolled 275 patients at 42 centers. After a mean follow-up period of 4.5 months, none of the 175 patients who underwent MR imaging had MRI-related complications. There were also no significant differences in the groups with regards to ventricular pacing capture threshold and sensing amplitude.