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Hi Ruth, My understanding is that that the hold-up is at the FDA level. STN stimulators are being implanted by some experimental surgeons approved by the FDA. My understanding is that Medicare will pay for this if it is done by these particular surgeons. I know that surgeons at Emery in Atlanta, NYU in New York and Rush-Presbyterian in Chicago are authorized. Some insurance companies will also pay but they often don't. The cost for paying for the procedure and devices is about $50,000. The FDA is between a rock and a hard place with this and other situations. To officially approve the device for the particular location of implantation they must have evidence of safety and efficacy. I believe there is an increased risk with implantation of an electrode at the STN over say the thalamus for which it is already approved since the STN is deeper and and in a more vascular area. We will bitch either way. If it is delayed they are holding it back and if it is OKed and trouble develops later then they are not protecting us (e.g. Tasmar). One would hope they can use the European Data to speed things up. Also this status of not being approved might give some people who are uninsured a chance to be part of the study group and possibly get free surgery (although I don't know this for a fact- they might just use medicare patients, insured (who will pay) and self-payers in their series. Maybe Bob Fink can comment on this as well, I am to be evaluated at NYU sometime in the next few months. I have seen the surgeon at Rush but because of the fetal transplant study I am in, it is preferable that I be seen outside of Rush since the surgeon will need to know what group I was in in the double blind study I am already in. I have yet to clear it with my insurance company and I obviously will need to clarify the situation prior to any surgery. The preliminary data on STN is extremely exciting and I am looking forward to the chance of trying it out. If anyone has had the surgery to date I would love to hear from you. Charlie ".Joan Waterman" wrote: > I would like to bring up the subject once again of the bilateral > STNDBS(subthalamic nuclei deep brain stimulator) which is under investigation > by FDA. The electronic implant has been approved for tremor (I don't > understand why Michael J. Fox did not opt for this) but not for other PD > problems. It is being used in Europe apparently quite successfully. I feel > that from what I have come to know about it, that it is the best way to go for > me and many others. I believe Ivan would be benefited greatly by it. > > I wrote FDA about why it has not been approved and their answer was that > Medtronic(the exclusive manufacturer) has it still being studied. Yet > Medtronic is apparently selling it in France! So what's the stall? > down on our use. Who knows? > > I'm thinking of our power together to get on Medtronics case and then FDA to > get this show on the road! The holidays are over and we must keep up our > pursuit of all the help available. IS ANYONE INTERESTED? I am going to > contact Medtronic again and find out what I can. > > Ruth Clark > [log in to unmask] >> > > ---------------------------------------------------------------------------------------------------- > > Subject: Back to PD > Date: Thu, 7 Jan 1999 08:23:17 EST > From: [log in to unmask] > To: [log in to unmask] > > I agree with Barb M. It sems that our correspondence has gone far afield from > our original reason for being. I have been hanging in there with my ever > ready "delete" key waiting for the helpful gems of wisdom that occasionally > fall out. I wouldn't have it any other way, but I know there's folks crying > out for help and I believe they are being short changed! > > I would like to bring up the subject once again of the bilateral > STNDBS(subthalamic nuclei deep brain stimulator) which is under investigation > by FDA. The electronic implant has been approved for tremor (I don't > understand why Michael J. Fox did not opt for this) but not for other PD > problems. It is being used in Europe apparently quite successfully. I feel > that from what I have come to know about it, that it is the best way to go for > me and many others. I believe Ivan would be benefited greatly by it. > > I wrote FDA about why it has not been approved and their answer was that > Medtronic(the exclusive manufacturer) has it still being studied. Yet > Medtronic is apparently selling it in France! So what's the stall? Has the > HMO's and Medicare stopped them because of the expense, or is Medtronic > holding it hostage, or is there something I haven't discovered? Perhaps the > drug companies would lose a lttle business, too, as it could certainly cut > down on our use. Who knows? > > I'm thinking of our power together to get on Medtronics case and then FDA to > get this show on the road! The holidays are over and we must keep up our > pursuit of all the help available. IS ANYONE INTERESTED? I am going to > contact Medtronic again and find out what I can. > > Ruth Clark > [log in to unmask] -- ****************************************************************************************** Charles T. Meyer, M.D. Middleton (Madison), Wisconsin [log in to unmask] ******************************************************************************************