Medtronic’s SureTune2 for Deep Brain Stimulation Therapy Granted CE Mark

Medtronic plc today announced it has received CE (Conformité Européenne) Mark for SureTune2 software, which provides patient-specific visualization to help physicians make decisions on how to program—or tune—their patient’s deep brain stimulation (DBS) therapy. SureTune2 is currently not approved in the United States.
 
DBS therapy applies mild electrical stimulation to precise targets in the brain in order to modulate specific symptom control. The brain targets are stimulated through lead(s) inserted into the brain and connected to an implantable neurostimulator through extensions running under the skin. A medical professional uses an external programmer to set and adjust stimulation settings.
 
Today DBS patient programming can be an interactive process, which can be time- consuming for the hospital and the patient. SureTune2 is designed for Medtronic DBS therapy and other DBS therapy delivery systems to help physicians more efficiently select the optimal stimulation settings on their programmer by visualizing patient-specific information in one comprehensive view including anatomy, physiology, and calculated stimulation field. Users can segment structures using a greyscale threshold within a region of interest, or by outlining shapes of interest from a patient image.
 
“SureTune will have an important impact on the care of patients with deep brain stimulation because it allows me for the first time to visualize activation patterns of DBS within the individual segmented patient anatomy,” said Professor Jens Volkmann, MD, PhD, FEAN, chairman and professor of neurology in the University Clinic of Würzburg. “It simplifies the trial and error process associated with DBS programming by helping me identify the best contacts, which saves me time.”
 
“Medtronic is committed to providing advanced technology to the multidisciplinary teams who are helping DBS patients, and I’m convinced that SureTune will provide them with easy-to-use tools to aid in optimizing therapy outcomes,” said Lothar Krinke, PhD, vice president and general manager of the Brain Modulation business in Medtronic’s Restorative Therapies Group. “SureTune is a key aspect of Medtronic’s commitment to providing integrated solutions for improving accuracy and confidence from surgery to post-operative DBS patient management.”
 
Medtronic helped pioneer DBS, and more than 140,000 patients worldwide have received Medtronic DBS Therapy, which is approved in many locations around the world, including Europe and the United States, for the treatment of the disabling symptoms of essential tremor, Parkinson’s disease and dystonia, the latter for which approval in the United States is under a Humanitarian Device Exemption (HDE). In Europe, Canada, and Australia, Medtronic DBS therapy is approved for the treatment of refractory epilepsy. Medtronic DBS therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in Europe and Australia, and in the United States under an HDE.