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FDA & Dornier

Posted by John h on 2/06/02 at 17:28 (072827)

if you will go to http://www.fda.gov and then enter Dornier in the search block on that site it will take you to the FDA results of the study on the Dornier Epos ESWT for Plantar Fasciaitis. It appears to me that the protocol they approved is different from that in Australia and Canada (if i read this correctly). In the U.S. studies only one treatment was used and a local block was used. In Australia and Canada 3 treatments and no block is the protocol. Between 60-70% of patients in the study who received the active treatment reported at least a 50% reduction in pain. Is this the way you read this Dr. Zuckerman. Why do you think the different protocol in the U.S.?

Re: FDA & Dornier

Dr. Zuckerman on 2/06/02 at 17:49 (072832)

I really don't know except maybe a one shot treatment that needs a local needs to go to the ASC. Just a quest . Not to happy. I still think you can use the machine like the orbie

Re: FDA & Dornier

John h on 2/06/02 at 18:15 (072838)

from a patients viewpoint i agree dr. z. why could you no in fact use the orby from the side the same as Dornier if you wanted to? Did you get a chance to read the FDA site I posted on the Dornier test results in the U.S. They used 150 patients with a mean age of just over 50. Most were women. Most appeared over weight it would seem as the average or mean weight for the women was right at 180 lbs. You were excluded if you had previous PF surgery, diabetic, any neuropathy disease, etc. The site did not say 'This is the protocol' but if they used a block and only 1 treatment in the study would that not indicate that is the protocol? Did Dornier give you a copy of the protocol?

Re: FDA & Dornier

Dr. Zuckerman on 2/06/02 at 17:49 (072832)

I really don't know except maybe a one shot treatment that needs a local needs to go to the ASC. Just a quest . Not to happy. I still think you can use the machine like the orbie

Re: FDA & Dornier

John h on 2/06/02 at 18:15 (072838)

from a patients viewpoint i agree dr. z. why could you no in fact use the orby from the side the same as Dornier if you wanted to? Did you get a chance to read the FDA site I posted on the Dornier test results in the U.S. They used 150 patients with a mean age of just over 50. Most were women. Most appeared over weight it would seem as the average or mean weight for the women was right at 180 lbs. You were excluded if you had previous PF surgery, diabetic, any neuropathy disease, etc. The site did not say 'This is the protocol' but if they used a block and only 1 treatment in the study would that not indicate that is the protocol? Did Dornier give you a copy of the protocol?