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Andy,

Thanks for the clear explaination.  That is my understanding of the situation
also.

Andy Blatz wrote:

> 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