The Fridley, Minn.-based medical technology giant said the expanded approval applies to patients receiving the Activa implant for the 1st time, plus some 13,000 European patients already implanted with Medtronic DBS devices.
"Medtronic is proud to be the only company to offer DBS systems to patients across Europe allowing them access to full-body MRI technology," vice president Lothar Krinke said in prepared remarks. "Additionally, now patients with MR conditional systems will be able to continue to receive the benefits of the therapy during the scanning procedure. Continuous advancements such as these set Medtronic apart and reinforce our commitment to the field of brain modulation."
Medtronic’s DBS therapy is approved in various jurisdictions for indications including essential tremor, Parkinson’s disease and chronic intractable primary dystonia, refractory epilepsy, and severe, treatment-resistant obsessive-compulsive disorder, the company said.
The devices were previously approved under limited conditions only for MRI scans of the head, according to a press release.
"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," Dr. John Thornton of London’s National Hospital for Neurology & Neurosurgery said the release. "Patients receiving DBS therapy can now receive more advantages of MRI technology."