Published on December 10, 2009 at 10:43 AM
Nexstim Oy, a medical device company, announced today that the
U.S. Food and Drug Administration (FDA) has cleared the Navigated Brain
Stimulation System for use in the assessment of the primary motor cortex
for pre-procedural planning.
Using transcranial magnetic stimulation (TMS) guided by standard
MR-image data, Nexstim has developed Navigated Brain Stimulation (NBS),
the first non-invasive direct technique for functional mapping of the
motor cortex. In its FDA submission, Nexstim included data comparing the
accuracy of NBS pre-operative mapping with the results of “gold
standard” direct cortical stimulation during actual brain tumor surgery.
Neurosurgeons have long awaited a reliable, non-invasive, tool for
pre-operative planning as an alternative to direct cortical stimulation,
an invasive technique which is performed after craniotomy at the
beginning of surgery. Cortical mapping with NBS is a major advance that
may help in tailoring neurosurgical treatment and planning to the needs
of the individual patient - potentially saving valuable time in the OR
and helping ensure the best possible outcome for the patient.
Lothar Koob, Chairman of the Board of Nexstim commented, “This
first FDA clearance for Nexstim marks an important milestone in the
development of the company, and based on very encouraging feedback from
clinicians we see many additional potential applications for our
proprietary navigated brain stimulation technologies.”
SOURCE Nexstim Oy