Re: DBS/STN?

[Perry Cohen <pdc@xxxxxxx>]

Almost one year after the unanimous recommendation for approval by the FDa
Advisory Committee (I was non-voting patient representative), DBS is NOT yet
approved by FDA. It is only available under experimental protocols.  While
neither the sponsor nor the FDA have made public what the concerns have been,
both have reported that they are working very hard to resolve the issues.  I
believe that some missing data and other additional information requested at the
hearing has been at least part of the problem.

I have received calls from people looking for information on where they can get
the procedure done, how much it costs, whether Medicare or insurance pay, etc.
Does anyone have this information?

With problems like this in mind, The Parkinson's Disease Foundation began
organizing the "Parkinson's - FDA - Industry Initiative" early this year to work
with Sponsors and the Government to provide patient input to design of clinical
trials and to the determination of risk-benefit tradeoffs for "timely" approval
of safe and effective new PD treatments. In our early stages of development we
have not worked with Medtronic to date. For more information see
www.parkinsonscare.org/RxDEV.html

Perry Cohen
Washington DC

----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:listserv@xxxxxxxxxxxxxxxxxxxx
In the body of the message put: signoff parkinsn