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Surgical Information Sciences Announces FDA 510(k) Clearance for Additional Visualization Capabilities in its DBS Targeting Software

PLYMOUTH, Minn., May 1, 2019 /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 new visualization capabilities.  Prior to this, the SIS software was cleared for visualization of brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a DBS procedure.  The STN is a key target for patients with Parkinson's disease.

The new capabilities enhance the industry-leading features of the SIS software, including:

  • Expanded visualization of the STN after completion of a DBS implant procedure through the fusion of MRI and CT images.
  • 3D visualization of the predicted location of the STN relative to the implanted DBS leads, including the identification of the lead contacts.
  • Improved user interface allowing for transfer of images through the web and a DICOM interface to permit seamless connection to medical centers.

"Today we announce another significant step forward in our drive to better targeting of the STN, particularly for patients undergoing a DBS procedure for the treatment of Parkinson's," said Jim Bullock, Chairman of the Board of Directors. "Parkinson's is a devastating and significantly prevalent disease around the world. The advancement of DBS has provided a potentially profound solution to patients who have exhausted pharmaceutical options. However, while DBS technology has advanced, it is still significantly underutilized because of lack of consistent results.  Studies have shown that 15% to 34% of patients undergo a revision or removal of the implanted leads and there is no definitive or optimal method for visualization and targeting the STN prior to or post implantation of the lead."

"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. "The software has demonstrated its ability to predict the location of the STN with an average surface distance accuracy of less than 1mm.  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 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."

This announcement follows the successful raise of a Series A financing in mid-2018 to help fund ongoing development and clinical research.  SIS was founded in 2012 through an intellectual property agreement with the University of Minnesota based on the work of Professors Noam Harel and Guillermo Sapiro.

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.

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SOURCE Surgical Information Sciences