The FDA has granted marketing clearance for new visualization software from Surgical Information Sciences (SIS) for use in deep brain stimulation (DBS) procedures.

The updated capabilities allow for expanded visualization of the subthalamic nuclei, a key target for DBS in patients with Parkinson disease. 

"Surgeons are seeking significant improvements in visualizing brain anatomy for targeting in DBS procedures, and the SIS software provides the most accurate capabilities in existence," said Brad Swatfager, president and chief executive officer of SIS, in a statement. 

The software update allows for neurosurgeons to not only plan and target the location of the subthalamic nuclei ahead of the procedure, but see where the DBS leads have been placed in relation to the location of the subthalamic nuclei post-procedure using a fusion of MRI and CT scans, as well as 3D visualization of lead contacts.

The update also offers an improved user interface allowing for the easy transfer of images over the web or a DICOM interface in order to facilitate sharing of data across medical centers.

“The software has demonstrated its ability to predict the location of the STN with an average surface distance accuracy of less than 1mm,” Swatfager added. “With this expanded FDA clearance, we will not only be able to assist in the planning and targeting prior to the procedure, but provide the ability to see where the lead was placed relative to the STN post procedure.”

“We believe this postoperative feature, along with the results of ongoing clinical studies of this SIS software, will demonstrate improved accuracy related to targeting and could provide a potential solution to creating much greater consistency of results leading to higher utilization of this life changing therapy,” Swatfager said.

The SIS software was developed by Noam Harel, PhD, an associate professor of radiology and neurosurgery and a faculty member of the Center for Magnetic Resonance Research at the University of Minnesota, and Guillermo Sapiro, PhD, the James B. Duke Professor of Electrical and Computer Engineering at Duke University, and combines highly sophisticated algorithms with high-field 7T MRI to produce 3D models of the brain.
REFERENCE
Surgical Information Sciences Announces FDA 510(k) Clearance for Additional Visualization Capabilities in its DBS Targeting Software [news release]. Plymouth, MN: Surgical Information Sciences. May 1, 2019. Accessed May 1, 2019. https://www.prnewswire.com/news-releases/surgical-information-sciences-announces-fda-510k-clearance-for-additional-visualization-capabilities-in-its-dbs-targeting-software-300842004.html