FDA approves first MRI-compatible ICD system
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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.