Results from the Evera MRI study, presented today at the annual Heart Rhythm Society meeting in Boston, showed no MRI-related complications among 275 patients randomized 2:1 to receive a course of MRIs or no MRI scans.
"The results of the study were very reassuring," principal investigator Dr. Michael Gold of the Medical University of South Carolina said today. "Zero patients in the whole study had complications associated with the MRI."
The study’s 2 main efficacy endpoints, changes to the minimal ventricular pacing threshold and R-wave amplitude, were also "clearly and very easily met," Gold said. In fact, he said, the only patient to demonstrate a ventricular pacing threshold change was in the control arm.
The Evera MRI SureScan won CE Mark approval in the European Union in April 2014, the same month that Medtronic launched a U.S. investigational device exemption trial for the device.
"Access to MRI scans is vital to ICD patients," vice president Dr. Marshall Stanton said in prepared remarks. "Medtronic has long been the leader in developing implantable devices that are approved for use in an MRI environment, and we look forward to being able to provide an MR-conditional ICD to patients."