Updated FDA Labeling for the Use of Deep Brain Neurostimulators in Full-Body MR Diagnostic Scan

The US Food and Drug Administration (FDA; Silver Spring, MD USA) has updated labeling of a series of Deep Brain Stimulation (DBS) neuro-stimulators, produced by a large medical technology company, enabling increased patient access to MRI scans.

The DBS neurostimulators are the first to receive FDA approval for full-body Magnetic Resonance Imaging (MRI) scans, dependent on specific conditions of use, and enable patients receiving DBS therapy to undergo MRI imaging. Previously, patients DBS were limited to low power Radio Frequency (RF) MRI head scans and the DBS system had to be switched off before the scan. The FDA approval enables increased MRI RF power limits, and scanning, and when programmed correctly the DBS systems can even continue to deliver therapy during scans.

The Medtronic (Dublin, Ireland) Activa portfolio of DBS Therapy systems uses a surgically implanted medical device to deliver mild electrical pulses to precisely targeted areas of the brain. A trained clinician can program and adjusted the system noninvasively to maximize symptom control and minimize side effects. Medtronic DBS Therapy is used by more than 130,000 patients worldwide.

Medtronic tested and evaluated the DBS systems using advanced electromagnetic modeling tools across 10 million simulated patient scans, and over 38,000 unique implant conditions, in order to ensure patient safety. The therapy is currently approved in US and Europe, for the treatment of the symptoms of Parkinson's disease, and chronic intractable primary dystonia, and in Europe, Canada and Australia for the treatment of refractory epilepsy. DBS therapy is also approved for the treatment of severe, treatment-resistant Obsessive-Compulsive Disorder (OCD) in Australia, the US (under Humanitarian Device Exemption regulations) and in the European Union.

Michael S. Okun, national medical director, US National Parkinson Foundation, said, "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. 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. 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."

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