Surgical Information Sciences Announces CE Mark for its DBS
PLYMOUTH, Minn., June 2, 2020 /PRNewswire/ -- Surgical Information Sciences (SIS), a medical device company focused on improved visualization of targets for deep brain stimulation (DBS) surgery, announced completion of requirements to apply CE Mark to market its visualization capabilities in Europe. Prior to this, the SIS System was cleared only in the United States for the visualization of brain structures such as the subthalamic nuclei (STN) in the planning, targeting and post-procedure images for a DBS procedure. The STN is a key target 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 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.
The SIS System through incorporation of machine-learning methods generates a patient-specific anatomical model with the shape and position of target brain structures identified. The patient-specific model allows for the visualization of a surgical target based on a patient's own MRI data providing the surgeon with additional imaging information for use in the planning and targeting of a procedure. Post-procedurally, the SIS System provides 3D visualization of the predicted location of the STN relative to the implanted DBS leads, including the identification of the lead contacts. Validation testing has demonstrated the ability of the SIS System to predict the location of the STN with an average surface distance accuracy of 1mm.
"We are pleased to announce completion of the requirements to apply CE Mark in Europe," said Brad Swatfager, President and Chief Executive Officer. "Surgeons are seeking significant improvements in visualizing brain anatomy for targeting in DBS procedures and the SIS System provides the most accurate capabilities in existence. With CE Mark complete, our focus will shift to the collection of clinical evidence to demonstrate the effect of the SIS System on the accuracy of targeting and the potential benefit on key metrics such as improved clinical patient outcomes with lower medication use and reduced time and effort in the planning, implantation and programming of the DBS lead(s)."
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 as an added 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