Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its SureTune3 deep-brain stimulation software, which is designed to map lead locations and indicate the level of stimulation.
The Fridley, Minn.-based Medtronic said its DBS devices are approved in the E.U. for treating Parkinson’s disease, dystonia, essential tremor, obsessive-compulsive disorder and epilepsy, claiming the portfolio as the only one to be full-body MR-conditional and able to operate during MRI scans.
and is the only DBS complete portfolio that, under specific conditions, is full body MR conditional and can be left on during an MRI scan.
“The latest innovations to our SureTune software take the Medtronic DBS solution to the next level: Beyond our former innovations of MR conditional devices and beyond the standard visualization of the stimulation field,” brain therapies president Brett Wall said in prepared remarks. “Medtronic has been leading the way in DBS therapy for more than 30 years and we will continue to explore and develop new innovations for both the patients and physicians who rely on them.”
“With SureTune3, I can integrate all patient data – both planning and procedure – which allows for more personalized management of each case,” added Dr. Jens Volkmann, of the University Clinic of Würzburg, who presented data on SureTune3 at the annual meeting of World Society for Stereotactic & Functional Neurosurgery this week in Berlin. “The improved software allows me to accurately visualize each DBS patient’s stimulation settings.”