Medtronic received the first approval in the U.S. for a MR-conditional implantable cardioverter defibrillator (ICD), allowing patients with the device to receive MRI scans over any part of the body given certain precautions. The Medtronic Evera MRI SureScan ICD relies on Sprint Quattro Secure MRI SureScan DF4 leads to be MRI compatible.
The Medtronic Evera MRI received CE Mark clearance in Europe back in April of last year.
From the announcement:
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 (JACC), 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.