Surgical Information Sciences (SIS) announced US FDA 510(k) clearance of an updated algorithm that provides new visualization capabilities for improved targeting in deep brain stimulation (DBS) surgery. The new capabilities include deep-learning models optimized for brain image segmentation, approval of the GPi/GPe—a key target for patients with Parkinson's disease—and the addition of functionality to determine the orientation of a directional DBS lead.
According to the company, the SIS System has approximately 70% better accuracy than atlas-based systems because it generates patient specific images to visualize the subthalamic nuclei (STN) and GPi/GPe. In Parkinson’s disease patients, DBS may be underutilized due to a lack of consistent results and challenges with the procedure.
"We are pleased to announce clearance of the latest version of the SIS System which is another significant step forward in visualizing the key targets for patients undergoing a DBS procedure for the treatment of Parkinson's," said Brad Swatfager, President and Chief Executive Officer at SIS. "This version is based on the latest deep learning models trained using proprietary imaging data which has taken almost a decade to collect. Use of these models has reduced processing times from 50 minutes to a few minutes with improved accuracy. Adding the GPi/GPe and detection of all commercially available leads in the US expands our offering to address almost all DBS procedures performed in patients with Parkinson's disease."
"Physicians and patients are seeking improvements in DBS focused on accurate anatomical lead placement. The SIS System provides a tool which could increase the efficiency of procedures by reducing or eliminating intraoperative steps required to confirm the DBS lead was placed correctly, potentially leading to faster procedures and the ability for patients to remain asleep during surgery" continued Swatfager. "The SIS System provides the only patient specific and most accurate tool for visualizing brain anatomy for DBS surgical planning. With this new FDA clearance, we will now shift focus to applying the CE Mark and having the ability to commercialize in the key DBS markets around the world. The value of SIS is based upon its ability to address customer concerns and provide an avenue to improve the DBS procedure and programming experience for physicians and most importantly, patients."Back To Top
Updated Algorithm Provides New Visualization Capabilities for Deep Brain Stimulation Surgery. Appl Radiol.