Re: DBS/STN?

[Raymond Strand <strandra@xxxxxxxxxxxxx>]

G'day:

I have been in contact with an old friend of mine (Minnesota).
He has been a free-lance technical writer for Medtronics (Minnesota
company).
He has had some work that relates to D B S.
Medtronics is the manufacturer of DBS  devices and  equipment.

The company thought that approval would go through last year,
and, is anxious for approval--of course. That is all I know.
My friend is not a decision maker with the company, but,
will let me know what is going on with new developments as they happen.

 Any major developments, will be  available as news releases,
and therefore available  to the list  through that route.

 It has been a good experience for him  to talk to me, because
knowing someone with Parkinsons puts a face it.


 ray

................................................................................

Perry Cohen wrote:
>
> 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
>
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--

                                 Ray Strand
                             Prairie Sky Design
 -----------------(   on  the Edge of the Prairie Abyss  )---------------
                          when  the  sky  is  clear
                            the ground is visible

                     49/dx PD 2 yrs/40? onset/retired

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