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News Briefs
Dystonia Patients Gain Access to "Brain Pacemaker"
The U.S. Food and Drug Administration has given special regulatory clearance
(April 15, 2003) so that Americans with the most disabling forms of dystonia
now have access to a type of therapy that is sometimes described as a brain
pacemaker. The FDA has granted a Humanitarian Device Exemption (HDE) for the
brain implant known as Activa Therapy, made by Medtronic, Inc., of Minneapolis.
Dystonia is a movement disorder in which involuntary muscle contractions force
the body into abnormal and often painful movements and positions. No known cure
exists. Standard medical therapy includes oral medications and injection treatments.
Activa Therapy will now be available to people whose dystonia does not respond
well to those treatments. Activa Therapy has already been approved by the FDA
to treat symptoms of advanced Parkinson's disease and essential tremor, the
two most common movement disorders.
Medtronic estimates that about 10 percent of dystonia patients are candidates
for treatment with Activa Therapy. The treatment uses brain stimulation technology
to deliver carefully controlled electrical pulses to precisely targeted areas
of the brain involved in movement control. The stimulation appears to block
the brain signals that cause the motor symptoms of Parkinson's disease and essential
tremor, and scientists believe it works the same way for dystonia.
People who want more information about Activa Therapy can visit www.brainpacemaker.com
or call (800) 494-4104.
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