Medtronic plc has announced that systems within its Activa portfolio of deep brain stimulation (DBS) therapy neurostimulators have received European regulatory approval for MR conditional full-body magnetic resonance imaging (MRI). The expanded approval for full-body MRI scans applies to all patients receiving a new system and to an estimated 13,000 people in Europe already receiving Medtronic DBS Therapy. Medtronic DBS systems have previously been approved for MRI scans of the head only, under limited conditions. Medtronic DBS systems are not approved in the United States for full-body scans.
MRI scans have become a diagnostic standard of care, allowing physicians to detect a wide range of health conditions by viewing highly detailed images of tumours, internal organs, blood vessels, muscles, joints and other areas of the body by using strong magnetic fields and radio frequency pulses to create images of structures inside the body. Worldwide, it is estimated that approximately 60 million MRI procedures are performed each year.
When programmed to appropriate settings, MR conditional Medtronic DBS systems allow patients to continue to receive therapy during MRI scans. Previously, patients receiving an MRI scan had their DBS systems turned off before the scan.
“MRI is commonly the method of choice to image the body to diagnose disease or monitor existing conditions, but MRI use has often been limited in patients receiving DBS therapy,” says John Thornton, medical physicist at the National Hospital for Neurology and Neurosurgery in London, UK. “Patients receiving DBS therapy can now receive more advantages of MRI technology.”
“Most patients who we consider for a DBS implant have other conditions which may require MRI,” says Ludvic Zrinzo, neurosurgeon at the National Hospital for Neurology and Neurosurgery in London. “The MR conditional Activa systems mean patients can receive DBS care, and still may have the option of MRI when needed to manage other conditions.”
To receive approval for MR conditional DBS systems, Medtronic developed proprietary test and measurement systems, in conjunction with advanced electromagnetic modelling tools. Existing Activa DBS systems were rigorously tested and evaluated across millions of simulated patient scans spanning over 38,000 unique implant conditions to demonstrate patient safety.