Interventional device developer Medtronic has received U.S. Food and Drug Administration (FDA) approval for an implantable cardioverter defibrillator system for use with MRI scanners.
The Medtronic Evera MRI SureScan implantable cardioverter defibrillator is approved for MRI scans on any part of the body without positioning restrictions. The newly approved system, which will be commercially available this month, includes the Evera device and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MR-conditional, the company said.
The FDA approval of Evera was based on safety and efficacy data from a multicenter, prospective, randomized, controlled clinical trial that enrolled 275 patients at 42 centers around the world. The data demonstrated that Evera is safe and effective, and that full-body MRI scans did not affect its ability to deliver therapy, according to Medtronic.
