PLYMOUTH, Minn., May 3, 2021 /PRNewswire/ -- Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced the first use of the SIS System which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The SIS System uses deep learning models to identify brain structures such as the subthalamic nuclei (STN) and globus pallidus internus/externus (GPi/GPe) commonly targeted for DBS procedures. The SIS System provides visualization of these structures for surgical planning and for location of the implanted DBS leads and lead contacts post-surgery.
The STN and GPi/GPe are key targets for patients with Parkinson's disease. The advancement of DBS has provided a potentially profound solution to patients with Parkinson's disease; however, it is still significantly underutilized due to a lack of consistent results and challenges with the procedure. Despite advances in imaging, the STN and GPi/GPe anatomy are too small to be accurately visualized with today's imaging capabilities. The SIS System generates patient specific images to visualize the STN and GPi/GPe which have approximately 70% better accuracy than the atlas-based systems used today.
"Placing a lead accurately in the target can make all the difference in patient outcomes and symptoms after DBS surgery" said Dr. Kyle Nelson, neurosurgeon from Metropolitan Neurosurgery in Minneapolis, MN, who conducted the first commercial use with the recently cleared software. "After comparing SIS to my standard target planning and intra-operative testing, I found the SIS image to be valid. SIS is more accurate than standard surgical planning programs I've used, and leaves no doubt as to where the target structure is located."
"This marks a significant milestone for SIS as we have spent 9 years building the most accurate visualization tool for the key targets used in DBS procedures for the treatment of Parkinson's. To finally have it used is very satisfying," said Brad Swatfager, President and Chief Executive Officer. "The improved accuracy of the visualized structure coupled with the ease of image use in the planning or programming should significantly improve the experience for physicians and patients."
SIS expects to apply the CE Mark to this latest version of the SIS System by the end of May.
About Surgical Information Sciences
SIS has developed a patented, state–of–the–art, clinically validated, patient–specific solution for the visualization of brain structures to be used in surgical planning to facilitate accurate determination of the target location for DBS surgery. The system utilizes highly sophisticated algorithms designed by international leaders in computer science and clinical applications to analyze complex data to provide the neurosurgeon with a rapid, objective and reliable assessment tool for their determination of the optimal location for electrode placement during DBS surgery. SIS technology produces three-dimensional anatomical models of brains, uniquely defined for each patient, created by using proprietary innovations in high–field MRI (7 Tesla or "7T") acquisition combined with proprietary data processing and analysis algorithms.
SOURCE Surgical Information Sciences