Medtronic (NYSE:MDT) said today that its Activa line of deep-brain stimulators won FDA approval for conditional, full-body MRI scans, claiming the devices as the only examples allowed on the U.S. market for full-body MR imaging.
The approval applies both to new Activa devices and to the roughly 43,000 U.S. patients already implanted with them, Fridley, Minn.-based Medtronic said.
“The use of MRI as a diagnostic tool has grown significantly, and Medtronic is proud to offer the only DBS systems that allow patients access to full-body MRIs,” brain modulation general manager Dr. Lothar Krinke said in prepared remarks. “Continuous innovation sets Medtronic apart, and we are allowing greater access to MRIs for those receiving DBS therapy as well as other implanted Medtronic systems such as pacemakers, ICDs and spinal cord stimulators.”
“Access to full-body MRI scans has been a critical unmet need with DBS therapy, as many patients require MRI imaging but could not always safely obtain it,” added Dr. Michael S. Okun of the National Parkinson Foundation. “There will be important guidelines for centers to follow in order to apply MRI imaging in patients, however, the availability of this type of imaging is an important step that will facilitate a more optimal care experience.”