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Dear All,

I detect yet more confusion over the issue of deep brain stimulation.  The
confusion is apparently over what is FDA-approved and what is actually
being performed in certain hospitals in the USA.  Here are the facts:  In
order for Medtronic, or other companies, to obtain FDA approval for a
particular use of one of their devices (in this case implantation of their
deep brain stimulator into either the globus pallidus (GP) or the
subthalamic nucleus (STN)) they must demonstrate that the procedure is safe
and effective.  They do this by performing experiments on humans, commonly
known as "clinical trials".  By the time that the procedures are performed
in clinical trials, the safety has been established, but the effectiveness
may not be confirmed.  This is what is happening in the US hospitals that
are implanting the Medtronic device in the STN and/or GP.  They are part of
the clinical trials for Medtronic, or possibly other companies.  The
procedures are definitely NOT FDA-approved.  You could say that the
procedures are FDA-sanctioned.  Because the procedures are not yet
approved, they are termed "investigational".  Investigational procedures
are often NOT covered by insurance.

And so, the bottom line is, yes, you can get a dbs in the STN or GP, but
you may have to pay for the procedure yourself.  If you are part of a
clinical trial, the company will probably pay for the device itself, but
will probably not pay for the actual surgery or other hospital expenses.
 Also, you will be assigned into experimental groupings that may not be
ideal for your symptoms (because, after all, these are experiments and the
best procedure is not known yet).

Again, thalamic stimulation for tremor is the only approved use for the
DBS, but the other two target sites, the GP and STN will probably be
approved within 1-2 years.

Andy