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The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices.

The SureTune4 Software is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Neural Activation (VNA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated preoperative and postoperative magnetic resonance imaging (MRI), Oarm™, and computed tomography (CT) images are uploaded to SureTune4 and can be navigated through in multiple 2D projections and 3D reconstructions. Medtronic DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. The SureTune4 Software mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translates potential stimulation settings and electrode configurations into a visualized VNA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. The SureTune4 software is used to do the following: - TM Import MR, O-arm ", and CT patient images over a DICOM network or from . physical media (hard drive, USB drive, CD, or DVD) - Import DICOM archives from StealthStation TM S7 TM systems with Cranial 3.x . software and StealthStation S8 Cranial software systems, and SureTune4 systems over a DICOM network - Combine MR. O-arm and CT images for more detail . - Superimpose an anatomical atlas to better understand the position of structures of . interest relative to a patient's anatomy - Manually segment structures of interest to highlight particular brain structures . - . Localize graphical Medtronic DBS lead models (based on preoperative imaging) - Enter electrophysiological annotations . - Visualize VNA fields relative to structures of interest in the patient anatomy or . lead position - . Create patient-specific stimulation plans for DBS programming - Generate reports that summarize stimulation plans for patients . - Export patient sessions to SureTune4 XLS spreadsheets (in Microsoft™ Excel format) .