Medtronic DBS Stimulators Cleared In Europe For Full-Body MRI
By Jof Enriquez,
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European regulators recently cleared Medtronic’s Activa deep brain stimulation (DBS) implants for use before and during full-body magnetic resonance imaging (MRI) procedures.
Medtronic DBS neurostimulators have previously been cleared for MRI head procedures alone, under certain conditions, including having to turn the DBS devices off during scans. Now, patients will be able to continue to receive therapy while undergoing full-body scans. The expanded approval covers future patients and the approximately 13,000 people in Europe already receiving Medtronic DBS therapy. The system is yet to be cleared for full-body MRIs in the United States.
“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,” said Dr. John Thornton, medical physicist at the National Hospital for Neurology and Neurosurgery in London, in a Medtronic press release. “Patients receiving DBS therapy can now receive more advantages of MRI technology.”
Many patients who receive DBS therapy also suffer from comorbidities. Medtronic’s new technology allows patients to undergo MRI scans without having their DBS therapy interrupted.
“Most patients who we consider for a DBS implant have other conditions which may require MRI,” Mr. Ludvic Zrinzo, neurosurgeon at the National Hospital for Neurology and Neurosurgery in London, said in the press release. “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.”
In order to gain MR Conditional DBS systems approval, Medtronic developed proprietary test and measurement systems, plus advanced electromagnetic modeling tools. To test for safety, the company evaluated millions of simulated patient scans spanning over 38,000 unique implant conditions.
Medtronic has recently either developed or acquired some of the latest novel technologies in the field of DBS therapy.
Last year, the company acquired Sapiens SBS and its next-generation deep brain stimulation (DBS) device, which utilizes an advanced lead with 40 individual stimulation points that enables precise stimulation of the brain with fewer side effects.
In 2013, Medtronic announced the successful implantation of the Activa PC+S DBS system, the first DBS system that has the ability to sense and record brain activity while simultaneously providing targeted DBS therapy.
DBS implants deliver mild electrical impulses to specific areas of the brain. A clinician programs the settings of the device noninvasively. DBS is approved in Europe and the U.S. for the treatment of essential tremor, advanced Parkinson’s disease, and chronic intractable primary dystonia, for which approval in the U.S. is under a humanitarian device exemption (HDE).
It is also approved in the U.S. under HDE for the treatment of severe, treatment-resistant obsessive-compulsive disorder, as well as in the EU and Australia for the same condition. DBS therapy is also approved for the treatment of refractory epilepsy in Europe, Canada, and Australia.
Image credit: Medtronic