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Update from an old OssaTron Gang member

Posted by Karen K on 10/04/00 at 12:43 (029764)

Hi All,
I know I haven't posted lately. I'm one of the 8 who had ESWT done in Canada. I had an extremly bad case and the treatment did wonders but, I'm one who needs multiple treatments. I've been tying to hold out for FDA approval of the Ossatron to be able to recieve treatment in the states. I am on the FDA e-mail list for notifications of PMAs and such. A little over a week ago I recived the e-mail from the FDA, 'July's Approvals' and there was no mention of the OssaTron. I was so upset I thought I'd call upthe FDA and give 'em hell! (in a nice way) Well, I got transferred around a few times until I ended up in someone's voicemail. Well, I left a message basically telling them to get their act together and asking them how much longer they thought approval would take. Much to my surprise, later that day, there was a message on my answering machine from the FDA. They apologised that they could not give me any info on the status of things but assured me the dicision would be made in a matter of weeks rather then months.

I'll keep my fingers crossed.

Re: Update from an old OssaTron Gang member

Barbara TX on 10/04/00 at 13:01 (029766)

I am confused. Hasn't the FDA given its approval yet? My understanding is that ESWT is available in the states. Many people have had it done in N.J, FL, TN and CA already. You can get it in the states. Perhaps its just your insurance company's coverage that you're waiting for? B.

Re: Update from an old OssaTron Gang member

Karen K on 10/04/00 at 14:05 (029773)

Yep, it's the whole insurance thing. As I understand it, the machines that are used now are registered with the FDA as a different class of divice then the OssaTron is going for. The OssaTron has done US clinical trials to prove safety and effictiveness of the product. As to my knowledge the Orbasone has not conducted or completed formal clinical trials in the US. Once a device has been proven effictive through clinical trials and Approved by the FDA in that respect, usually the Insurance companies will eventually pick up the tab (or you have a better leg to stand on in trying to get them to pay).

I hope I answered your question.
K.

Re: Update from an old OssaTron Gang member

Brandy on 10/09/00 at 21:08 (030126)

Can you tell me where in California the Ossatron treatment is available? Thanks.

Re: Update from an old OssaTron Gang member

Bob Ray on 10/12/00 at 16:29 (030375)

I have had two treatments at Mike Shapow's Rehab Healthcare, 6222 Wilshire Blvd suite 302 LA CA 90048 323 965 7333 http://www.myheelpain.com $1000/ condition for 3 treatments. I understand Cedar's Sinai in LA does it, but I couldn't get any help thru their maze of disorganization. UC Davis has a machine. But I think you have to be a horse to use it.
Good luck

Re: Update from an old OssaTron Gang member

Barbara TX on 10/04/00 at 13:01 (029766)

I am confused. Hasn't the FDA given its approval yet? My understanding is that ESWT is available in the states. Many people have had it done in N.J, FL, TN and CA already. You can get it in the states. Perhaps its just your insurance company's coverage that you're waiting for? B.

Re: Update from an old OssaTron Gang member

Karen K on 10/04/00 at 14:05 (029773)

Yep, it's the whole insurance thing. As I understand it, the machines that are used now are registered with the FDA as a different class of divice then the OssaTron is going for. The OssaTron has done US clinical trials to prove safety and effictiveness of the product. As to my knowledge the Orbasone has not conducted or completed formal clinical trials in the US. Once a device has been proven effictive through clinical trials and Approved by the FDA in that respect, usually the Insurance companies will eventually pick up the tab (or you have a better leg to stand on in trying to get them to pay).

I hope I answered your question.
K.

Re: Update from an old OssaTron Gang member

Brandy on 10/09/00 at 21:08 (030126)

Can you tell me where in California the Ossatron treatment is available? Thanks.

Re: Update from an old OssaTron Gang member

Bob Ray on 10/12/00 at 16:29 (030375)

I have had two treatments at Mike Shapow's Rehab Healthcare, 6222 Wilshire Blvd suite 302 LA CA 90048 323 965 7333 http://www.myheelpain.com $1000/ condition for 3 treatments. I understand Cedar's Sinai in LA does it, but I couldn't get any help thru their maze of disorganization. UC Davis has a machine. But I think you have to be a horse to use it.
Good luck