Surgical Information Sciences Announces FDA 510(k) Clearance for Additional Anatomical Structures for its DBS Visualization Software

MINNEAPOLIS, April 5, 2021 /PRNewswire/ -- Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market an updated algorithm with new visualization capabilities. Prior to this, the SIS System was cleared for visualization of brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a DBS procedure and visualization of the location of the STN relative to the implanted DBS leads, including identification of the lead contacts.

The updated algorithm and new capabilities enhance the industry-leading features of the SIS System, including:

  • Updated algorithm based on deep learning models optimized for brain image segmentation
  • Approval of the GPi/GPe in addition to the previously approved STN
  • Addition of functionality to determine the orientation of a directional DBS lead

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. The SIS System has approximately 70% better accuracy than atlas-based systems because it generates patient specific images to visualize the STN and GPi/GPe.

"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. "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 Mr. 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."

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 in order to accurately determine 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 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