FDA approves the Evera MRI SureScan ICD System for arrhythmias-Medtronic

Medtronic has received the first FDA approval for the Evera MRI SureScan ICD System, an implantable cardioverter defibrillator system for use with magnetic resonance imaging (MRI) scans. The system is approved for MRI scans on any part of the body without positioning restrictions, which means that patients in the U.S. who depend on life-saving ICDs also now have access to MRI scans if and when they need them. The newly approved system, which will be commercially available this month, includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MR-conditional.

The FDA approval of the Evera MRI ICD system was based on safety and efficacy data from the Evera MRI Clinical Trial, a multicenter, prospective, randomized, controlled clinical trial that enrolled 275 patients at 42 centers around the world. Presented during a late-breaking clinical trial session at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, and published simultaneously in the Journal of the American College of Cardiology, these data demonstrated that the Evera MRI ICD system is safe and effective, and that full-body MRI scans did not affect its ability to deliver life-saving therapy.