Interventional device developer Medtronic Canada has received a Health Canada license for its Evera MRI SureScan implantable cardioverter defibrillator (ICD) system.
Evera MRI ICD is licensed for MRI scans on any part of the body without positioning restrictions, according to the vendor. The newly licensed system includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MRI-conditional, Medtronic said.
The system includes hardware and software design enhancements from previous generation devices that allow it to safely undergo full-body MRIs, Medtronic said.
The Health Canada license 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 session at the Heart Rhythm 2015 meeting in May and published simultaneously in the Journal of the American College of Cardiology, the trial results demonstrated that Evera MRI ICD is safe and effective when used as directed, and full-body MRI scans did not affect its ability to deliver therapy, according to the company.
