The Food and Drug Administration (FDA) has granted marketing clearance for a software package (Surgical Information Sciences, Plymouth, MN) to guide implantation of deep brain stimulators (DBS) for treatment of Parkinson’s disease.
Approximately 15% to 34% of people treated with DBS for PD need revision or removal of implanted electrodes, in part because methods for visualizing the implantation target(s), the subthalamic nuclei (STN), has been suboptimal. With this new software, the predicted location of the STN can be visualized in 3 dimensions. Using combined CT and MRI images, the software also allows expanded postprocedural visualization of STN.
"The software has demonstrated ability to predict the location of the STN with an average surface distance accuracy of less than 1 mm,” said Brad Swatfager, president and chief executive officer, Surgical Information Sciences. “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 post-operative feature, along with the results of ongoing clinical studies of this 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."
Matthew Varon, MD; and Pedro M. Machado, MD, PhD
Wijdan Rai, MD; and Bakri Elsheikh, MBBS
Arnold M. Salazar; Amanda M. Leisgang; Andrew A. Ortiz; and Jefferson W. Kinney, PhD