FDA Panel Recommending "Deep Brain Stimulator" Manufacturer of
Pacemaker-like Deep Brain Device reports Dramatic Reductions in Tremors
On Friday, March 14th, the Neurological Device Panel Advisory Committee
to the U.S. Food and Drug Administration (FDA) unanimously recommended that
FDA approve for immediate use a deep brain stimulation device to control
Parkinson's tremor.
Medtronic, Inc., the Minneapolis company that developed the device is
hopeful that final clearance will be received by May 1st.
Network President Joan Samuelson testified at the march 14th hearing,
telling the panel that the Parkinson's community needs the fastest possible
review of the device. "Deep brain stimulation appears to be the next step
beyond the currently popular practice of lesioning the brain through
pallidotomy or thalamotomy, perhaps offering the same relief with less risk,"
she noted.
The therapy, known as "Activa tremor control," uses an implanted device
similar to a cardiac pacemaker to deliver electrical stimulation to block or
override brain signals that cause tremor. Data presented by Parkinson's
researcher William Koller, M.D. and an accompanying video, showed a dramatic,
instant reduction in tremor when the device was activated. The benefit
appears to be the same as thalamotomy, a surgical lesion used for tremor
control, without creating a permanent lesion.
Metronic reports 2,000 patients in Canada, Europe and Australia are
already using Activa to successfully control tremor caused by either
Parkinson's or Essential Tremor. Researchers present at the hearing,
including Dr. Koller of University of Kansas and Warren Olanow, M.D. of Mt.
Sinai Medical Center, say a similar device to control additional Parkinson's
symptoms is under development.
Further information on the device is available from Metronic by calling
800-328-0810.
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Parkinson's Action Network 800-850-4726
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phone 202-628-2079 fax 202-628-2077
Brad Udall, Chair
Joan I. Samuelson, President
John L. Dodge, Treasurer
Bonnie K. Mioduchoski, Administrator
Michael Claeys, Community Coordinator
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