Medtronic SURETUNE2TM software is CE certified to optimize brain deep electrical stimulation therapy program-controlled operation

Release date: 2016-08-18

The new visual operating platform provides patient-specific visual images and data to help doctors make informed programmatic decisions

                      
 
Dublin August 17 --- --- Medtronic recently announced SureTune2 â„¢ software has received the European Union CE certification, the software can provide visual information specific to the patient, help doctors decide how to have deep brain stimulation (DBS) of the implant The patient undergoes relevant surgical programming or adjustment. Following the EU CE certification, SureTune2 is currently awaiting approval from the US FDA.
 
DBS therapy controls related disease symptoms by gently electrical stimulation of precise targets in the brain. The target is stimulated by an implanted electrode that is connected to the implantable neurostimulator via a subcutaneous pathway. Medical professionals use an external programmer to set and adjust settings related to the stimulator.
 
The current DBS program control is an interactive process that consumes a lot of time for both the hospital and the patient. SureTune2 was originally designed to work with Medtronic DBS Therapy and other delivery systems to provide a comprehensive view of patient-specific information, including anatomy, physiology and precision stimulation, to help doctors set optimal modes of the programmer more efficiently. . The user can use the grayscale threshold to segment the region of interest or outline the shape of interest from the patient image.
 
“SureTune will have a major impact on the care of patients with DBS because it allows me to implement a visual DBS activation model on a single patient for the first time,” said Professor Jens Volkmann, Department of Neurology, University of Würzburg. “By helping to find the best Contacts, which simplifies the process of repeated debugging of DBS program control, saving me time."
 
“Melton is committed to providing advanced technology to multidisciplinary teams that help DBS patients. I believe SureTune will be an easy-to-use tool for them and will further help optimize treatment outcomes,” said Medtronic, vice president and brain of restorative therapy business. Dr. Lothar Krinke, head of departmental regulation, said, "SureTune is a key part of Medtronic's commitment to providing a comprehensive solution for the accuracy and confidence of intraoperative and postoperative management of DBS patients."
 
More than 140,000 patients worldwide have received Medtronic DBS therapy, which is currently licensed in several regions of the world, including Europe, the United States, and China, including indications for essential tremor, Parkinson's disease, and dystonia. Dystonia is currently approved for use as a Humanitarian Device Exemption (HDE) in the United States. In Europe, Canada and Australia, Medtronic DBS therapy is approved for the treatment of intractable epilepsy. At the same time, in Europe and Australia, Medtronic DBS therapy is also approved for the treatment of refractory obsessive-compulsive disorder, and patients with this disease in the United States can also receive Medtronic DBS therapy through HDE exemption.

Source: Medtronic

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