Home The Book Dr Articles Products Message Boards Journal Articles Search Our Surveys Surgery ESWT Dr Messages Find Good Drs video

You could help---FDA panel meeting

Posted by Pauline on 6/20/00 at 16:06 (022123)

After reading the information on the other board posted by Karen K.
telling about the upcomming FDA vote on premarket approval application
for a shock wave lithotriptor (OssaTron and others) you that have had
this treatment may be able to help get it approved.

The posting reads:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by July 13,2000. Oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m. on July 20. At the end of the committee diliberations A Thirty Minute Open Public Session will be
conducted for interested persons to address issues specific to the submission before the committee.

This may be our chance to be heard. How about writing a letter, all
of us and especially those that have been helped by the OssaTron. The rest of us can tell our stories how we are waiting for this surgical
alternative and for how long.

I personally would like to go to this meeting and speak in the public
session. I think this is our chance to make a big difference.
Please read Karen's posting and decide to make a difference. The
address is posted there.

John
Will you be going to this meeting. It's your company


Re: You could help---FDA panel meeting

john h on 6/20/00 at 17:21 (022127)

john could you please advise what will happen if the committee approves the ossatron for treatment. will it be available immediately for use by the public. are there doctors standing in line to buy the machine? how long does it usually take to get medicare to approve a new procedure?

Re: You could help---FDA panel meeting

johnw on 6/20/00 at 18:48 (022135)

I will probably not be attending the meeting due to the fact that the stress of watching the panel vote would probably kill me.

It is my understanding that after the panel votes the fda usually takes up to a month to accept or deny the recommendation. As of when I left, there was a lot of interest by Drs.,etc. wanting to buy the devices. The short term problem will be meeting demand and ensuring that the Drs. are adequately trained so that their results do not vary from the international and fda study standards. It will probably take a year before the devices are located in all the major cities.

With respect to medicare, the fda recommended to HCFA that the procedure be reimbursed. However, a code must first be established. This could take a few months. Insurance reimbursement will also be slow at first although several companies reimbursed during the course of the study.


Re: You could help---FDA panel meeting

john h on 6/20/00 at 17:21 (022127)

john could you please advise what will happen if the committee approves the ossatron for treatment. will it be available immediately for use by the public. are there doctors standing in line to buy the machine? how long does it usually take to get medicare to approve a new procedure?

Re: You could help---FDA panel meeting

johnw on 6/20/00 at 18:48 (022135)

I will probably not be attending the meeting due to the fact that the stress of watching the panel vote would probably kill me.

It is my understanding that after the panel votes the fda usually takes up to a month to accept or deny the recommendation. As of when I left, there was a lot of interest by Drs.,etc. wanting to buy the devices. The short term problem will be meeting demand and ensuring that the Drs. are adequately trained so that their results do not vary from the international and fda study standards. It will probably take a year before the devices are located in all the major cities.

With respect to medicare, the fda recommended to HCFA that the procedure be reimbursed. However, a code must first be established. This could take a few months. Insurance reimbursement will also be slow at first although several companies reimbursed during the course of the study.