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