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FDA Panel Meeting Notes on OssaTron

Posted by Scott R on 8/15/00 at 19:57 (025523)

Thanks to John H for sending me the following file.

http://heelspurs.com/eswt/ossatronpma.html



Re: FDA Panel Meeting Notes on OssaTron

john h on 8/16/00 at 17:23 (025589)

scott: after reading the full transcript it seems to me that at least initially only orthopedic foot and ankle surgeons who have been trained by Healthtronics will be able to perform this procedure. 1st in line will most likely be Dr Alverez in Chattanooga who is arlready trained. I did not read that they insisted on a given power setting but looks like around 18 joules and 1500 shocks. It was interesting to note that improvement up to 12 weeks they could consider due to ESWT treatment. improvement after that might just be improvement do to the natural course of events. there was one test mentioned for neuropathy which seemed very simple and invlolved cuffing the thigh and taking some readings. i would like to know more about that. The FDA will approve it but you can bet they will tack on some exceptions.

Re: FDA Panel Meeting Notes on OssaTron

Pauline on 8/16/00 at 18:54 (025598)

John,
Part of my letter is printed in the Introduction section that you
sent to Scott. Yea It is verbatim. You will recall that three
others posting also sent letters. That is exactly how it is reported. Hay, maybe we made the difference, at least I'd like to
think that. I don't think it will hurt anyone if we do! Still got
my great letter.

Re: FDA Panel Meeting Notes on OssaTron

john h on 8/16/00 at 19:00 (025600)

pauline: your letter could only have helped!!! congratualtions on your contribution. i was mesmerized reading the minutes of the meeting good insight as to how they operate. i will be very interested as to what conditions the FDA attaches on to the use of the OssaTron. An example might be you could be excluded if you have osteoporosis?

Re: FDA Panel Meeting Notes on OssaTron

Dr. Zuckerman on 8/16/00 at 22:49 (025620)

The attachments will probaby be neuropathy, immosuppressant diseases,
maybe certains type of PVD, patient on blood thinners.

The possibility of of being able to use the ossatron before six months of conversative treatment could be a problem for patients and this is what concerns me when you have insurance company intervention. If they do pay if won't be until the doctor has used a cook book treatment plan which has to be cooked for six months before you can try to shock the meal


Re: FDA Panel Meeting Notes on OssaTron

Dr. Zuckerman on 8/16/00 at 23:05 (025623)

I believe that the test that they were talking about is the use of a 10mg monofilament test. This is where you use a very thin plastic bending filament much like a fishing tackle line to touch various areas of the foot usually on the plantar aspect of the foot under the heel, first and fifth metatarasl heads. Another test I use is the simple use of a tuning fork. The first two clinical signs of neuropathy is one the lack of ability to feel pressure and the inability to know when vibration has started in the foot and when it has stopped to vibrate in the foot. If is my impression that the panel was very impressed with the Healthronic presentation and the rest of the discussion was just show. I don't know if you have ever been to a zoning board meeting in your local community but it read like a very typical zoning board meeting execept I though that the FDA was very nice and wanted to pass the ossatron . just my take.

Re: FDA Panel Meeting Notes on OssaTron

john h on 8/17/00 at 09:48 (025647)

dr Z: i would like for you to apply the tunning fork and monofiliment test to my feet when i am there next week. i like the tunning fork procedure. simple!

Re: FDA Panel Meeting Notes on OssaTron

Dr. Zuckerman on 8/17/00 at 15:20 (025669)

This is part of a orbasone examination for evaluation of ESWT

Re: FDA Panel Meeting Notes on OssaTron

john h on 8/16/00 at 17:23 (025589)

scott: after reading the full transcript it seems to me that at least initially only orthopedic foot and ankle surgeons who have been trained by Healthtronics will be able to perform this procedure. 1st in line will most likely be Dr Alverez in Chattanooga who is arlready trained. I did not read that they insisted on a given power setting but looks like around 18 joules and 1500 shocks. It was interesting to note that improvement up to 12 weeks they could consider due to ESWT treatment. improvement after that might just be improvement do to the natural course of events. there was one test mentioned for neuropathy which seemed very simple and invlolved cuffing the thigh and taking some readings. i would like to know more about that. The FDA will approve it but you can bet they will tack on some exceptions.

Re: FDA Panel Meeting Notes on OssaTron

Pauline on 8/16/00 at 18:54 (025598)

John,
Part of my letter is printed in the Introduction section that you
sent to Scott. Yea It is verbatim. You will recall that three
others posting also sent letters. That is exactly how it is reported. Hay, maybe we made the difference, at least I'd like to
think that. I don't think it will hurt anyone if we do! Still got
my great letter.

Re: FDA Panel Meeting Notes on OssaTron

john h on 8/16/00 at 19:00 (025600)

pauline: your letter could only have helped!!! congratualtions on your contribution. i was mesmerized reading the minutes of the meeting good insight as to how they operate. i will be very interested as to what conditions the FDA attaches on to the use of the OssaTron. An example might be you could be excluded if you have osteoporosis?

Re: FDA Panel Meeting Notes on OssaTron

Dr. Zuckerman on 8/16/00 at 22:49 (025620)

The attachments will probaby be neuropathy, immosuppressant diseases,
maybe certains type of PVD, patient on blood thinners.

The possibility of of being able to use the ossatron before six months of conversative treatment could be a problem for patients and this is what concerns me when you have insurance company intervention. If they do pay if won't be until the doctor has used a cook book treatment plan which has to be cooked for six months before you can try to shock the meal


Re: FDA Panel Meeting Notes on OssaTron

Dr. Zuckerman on 8/16/00 at 23:05 (025623)

I believe that the test that they were talking about is the use of a 10mg monofilament test. This is where you use a very thin plastic bending filament much like a fishing tackle line to touch various areas of the foot usually on the plantar aspect of the foot under the heel, first and fifth metatarasl heads. Another test I use is the simple use of a tuning fork. The first two clinical signs of neuropathy is one the lack of ability to feel pressure and the inability to know when vibration has started in the foot and when it has stopped to vibrate in the foot. If is my impression that the panel was very impressed with the Healthronic presentation and the rest of the discussion was just show. I don't know if you have ever been to a zoning board meeting in your local community but it read like a very typical zoning board meeting execept I though that the FDA was very nice and wanted to pass the ossatron . just my take.

Re: FDA Panel Meeting Notes on OssaTron

john h on 8/17/00 at 09:48 (025647)

dr Z: i would like for you to apply the tunning fork and monofiliment test to my feet when i am there next week. i like the tunning fork procedure. simple!

Re: FDA Panel Meeting Notes on OssaTron

Dr. Zuckerman on 8/17/00 at 15:20 (025669)

This is part of a orbasone examination for evaluation of ESWT