Medtronic, Irish medical device company, has received the first U.S. Food and Drug Administration (FDA) approval for an implantable cardioverter defibrillator (ICD).
The Medtronic Evera MRI SureScan ICD System is approved for MRI scans on any part of the body without positioning restrictions. This means patients in the United States who depend on life-saving ICDs also now have access to MRI scans if and when they need them.
The approved system includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MR-conditional.
"Patients at risk for sudden cardiac arrest have long relied on ICDs to monitor their hearts, detect dangerous arrhythmias and deliver the life-saving therapy needed to survive. Many of these patients also need access to MRIs, so the approval of an ICD that can be used in an MRI environment is crucial, and can help provide patients with the peace of mind that they are receiving the best care available," said Michael R. Gold, M.D., Ph.D., chief of cardiology, Michael E Assey Professor of Medicine at the Medical University of South Carolina, and principal investigator in the Evera MRI Clinical Trial.
The approval of the 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.