Activa deep brain stimulation systems receive FDA approval for full-body MRI


Deep brain stimulation (DBS) systems within the Medtronic Activa portfolio have received US Food and Drug Administration (FDA) approval for full-body magnetic resonance imaging (MRI), under certain conditions of use.

This makes the company’s MR Conditional DBS systems the only products approved for full-body MRI scans. This approval applies to people receiving new Medtronic DBS systems, and to those 43,000 patients already receiving Medtronic DBS Therapy in the USA, so long as updated MRI guidelines are followed.

“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,” says Michael S Okun, national medical director at the National Parkinson Foundation. “There will be important guidelines for centres 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.”

Since FDA approval of MRI instructions for use in 2002, patients with Medtronic DBS have been able to receive head scans at a low radiofrequency (RF) power limit, but the DBS system had to be turned off before the MRI scan. Now with full-body scanning capability, increased MRI RF power limit are designed allow for improved image quality, faster scan times, or larger scan coverage for better diagnostic capabilities.  Additionally, when programmed to appropriate stimulation settings, and when certain other conditions have been met, Medtronic DBS systems should allow patients to continue receiving therapy during scans.

“Medtronic is proud to offer the only DBS systems that allow patients access to full-body MRIs,” says Lothar Krinke, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. “We are allowing greater access to MRIs for those receiving DBS therapy as well as other implanted systems such as pacemakers, ICDs and spinal cord stimulators.”

According to a press release, Medtronic performed rigorous safety testing, including developing proprietary test and measurement systems, in conjunction with advanced electromagnetic modelling tools. Activa DBS systems were tested and evaluated across 10 million simulated patient scans spanning over 38,000 unique implant conditions to demonstrate patient safety. In all, Medtronic has 14 years of MRI research and testing experience.