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So what's the vote do we send a letter to the FDA- Scott

Posted by Dr. Zuckerman on 10/14/01 at 02:03 (062956)

We have talked back and forth about the too much money for USA ESWT. What is the vote for sending in a petition to the FDA or the omnibus representative to express our concern about the cost. As I have stated before a re-classification of the entire ESWT for plantar fasciitis and other insertional tendonits to class one pain management would bring the price right down to the level where alot of companies would be able to bring machine to the USA next week. Do we vote. or do you just stand by and let the system work by itself which will keep the costs up for the next two to three years.

Scott what do you think of this idea.

Re: So what's the vote do we send a letter to the FDA- Scott

Dr. Zuckerman on 10/14/01 at 02:06 (062957)

I want to point out that this idea only hurts Dr. Z cause I have a machine that enables me to not have to charge 10,000 dollars . My goal is to be able to have more machines so that the price could come down even more.

Right now I benefit from this market the way it is.!!! So this idea is strictly for getting ESWT out to public on a volume scale.

Re: So what's the vote do we send a letter to the FDA- Scott

Scott R on 10/14/01 at 06:59 (062958)

We need documents from the FDA explaining why it's classified the way it is to make sure it's not appropriately classified. I could then send out an informative email to the ESWT email list (2,000 people) and put it on the ESWT page explaining things and bringing patients 'up to speed' before providing mailing addresses and information on how to effect a change. I think there is a litho meeting this week, so the ESWT companies are probably not seeing this, so the time for discussion may be off.

Re: So what's the vote do we send a letter to the FDA- Scott

Dr. Zuckerman on 10/14/01 at 15:46 (062983)

What ever classification system that removes double bind studies and removes mutlti-center studies is a big start. I believe that the same classificaion system that ultra sound is used is perfect. This would be a Class one . Pain management would be the proper indication. I do know that
the orbasone system used a class one application and that is why it entered the market so fast. So we have a choice class one , class two, or class three.

We know that two and three take too much time class one is the fastest. I also know that with the orbasone they provided studies showing the lack of damage to bone with high power energy with their specific device. So animal studies would have to be included if the companies wouldn't tell you exactly what the mj/mm2 would at the f2 treatment spot.

In my minde this is so simple. Let the doctors and the universities spent the money to do research on specific condition. This is what is being done every day with surgical procedures. so why not ESWT.

Yes the safety factor would have to be completely answered which I feel it already has but the efficiency factor well that is up to the medical field and the buy can determine this by careful education and comparison

Deos this make senses or am I just making this very simple because in my mind it is simple if you remove the manusfactors from the picture.

Re: Steps to Class 1 success

Scott R on 10/14/01 at 18:03 (062986)

Getting ESWT machines classified as Class 1 probably isn't just a matter of patients sending letters. Having the law on the side of making a machine class 1 is an absolute necessity. First we need to know how the law works in machine classification, then we need a machine that fits those requirements, and then we can petition the FDA.

I don't know how the FDA would view patients trying to make a machine class one when the company wants it class 3. Orbasone's FDA woes would indicate success is unlikely even with the support of the company. Politics is involved only to the extent that other manufacturers can acquire FDA's ear with valid complaints of the FDA allowing unfair competition in violation of its own regulations.

We all have to make a living and few of us have the time to persue avenues that are unlikely to succeed. There is no pot of gold at the end of the rainbow, eventhough many would be helped. This is the key if not only remaining problem with our system of government and economics. Now that Dr. Z and I have gone to the effort of discussing it, maybe someone else will do the legal background work addressing the issues I've mentioned above. http://www.fda.gov is a greatly informative website.

Re: Steps to Class 1 success

Dr. Zuckerman on 10/14/01 at 18:30 (062987)

I agree that the solution isn't simple . Maybe just a letter of support
to reduce the process tot he quickest method and at the same time the safest method possible. I will repeat safety is important and proof of sucess for a specific condition should be left to the medical field.

If I knew how to move forward with this believe me I would I just have
no idea how to do this. I have watched the process up close and see that
what I am saying isn't off the wall it may place companies that are
making ESWT machines stock go down the tubes but that isn't a medical
problem that is a finanical problem . So I hope that someone out there has the same strenght that Scott Roberts has when he came up with heelspurs.com
and that person can lead this fight in the cure for plantara fascia pain.

Are you out there we need you. Time only makes pf worse not better.!!!!!

Re: Steps to Class 1 success

David on 10/15/01 at 11:36 (063007)

I agree that the cost of ESWT treatments right now is prohibitively high. One of the main reasons I believe is that there is no competition right now....the Ossatron being the only FDA approved device out there. Although there are a few Orbasone machines, because of their issues with the FDA, I don't think you'll see an expansion of that device.

Once the low-energy devices become available on the market, possibly by the end of the year, I wouldn't be surprised to see the cost per treatment drop to the hundreds, instead of thousands. These devices, which will be much more affordable, and will not require anesthesia or imaging, and can be done in a doctor's office instead of a surgery center should dominate the market.

Rather than getting the FDA to change their regulatory structure, I think that good old fashioned competition will lower prices rapidly. David

Re: Steps to Class 1 success

Dr. Zuckerman on 10/15/01 at 14:19 (063016)

We have talked about this before David and I hope you are right but I still can't see how the soncur is going to make a big change with the present market structure. Unless I am not understanding the structure the cost of the machines is too high and the ability for the treating doctor to make a fair profit is too low. Very interesting how I will be able to use soncur for plantar fasciitis without it going thru FDA trials. The fact that if did go thru elbow FDA trials and since it did this it is ok to use it for plantar fasciitis treatment is ok but the system in my opinion is wrong and set up to create a lack of competition. The small company who can produce a machine that may be better and cheaper is left out of the picture.

The FDA or use of the FDA by companies is what has created this and so long as it stays this way the price will stay up there.

Re: Steps to Class 1 success and other treatments

Pauline on 10/17/01 at 23:09 (063203)

I think Scott is correct about the law. I remember reading some where that when one medical device is already FDA approved and rated as a Class III device all other medical devices that follow in it's footsteps must also be classified exactly the same. Can't quote it exactly, but I do remember reading something about it.

Another point I'd like information on, is using ESWT as a treatment for neuromas or other foot conditions which were not part of the original FDA application approval usage and for which no studies have been done.

Dr. Jan Rompe who's known for his research with ESWT said in a recent e-mail that he knows of no studies having been done using ESWT to treat neuromas. If this is the case is Healthronics allowing their Ossatron to be used to treat neruomas in patients and what are they charging for this treatment?

Re: So what's the vote do we send a letter to the FDA- Scott

Dr. Zuckerman on 10/14/01 at 02:06 (062957)

I want to point out that this idea only hurts Dr. Z cause I have a machine that enables me to not have to charge 10,000 dollars . My goal is to be able to have more machines so that the price could come down even more.

Right now I benefit from this market the way it is.!!! So this idea is strictly for getting ESWT out to public on a volume scale.

Re: So what's the vote do we send a letter to the FDA- Scott

Scott R on 10/14/01 at 06:59 (062958)

We need documents from the FDA explaining why it's classified the way it is to make sure it's not appropriately classified. I could then send out an informative email to the ESWT email list (2,000 people) and put it on the ESWT page explaining things and bringing patients 'up to speed' before providing mailing addresses and information on how to effect a change. I think there is a litho meeting this week, so the ESWT companies are probably not seeing this, so the time for discussion may be off.

Re: So what's the vote do we send a letter to the FDA- Scott

Dr. Zuckerman on 10/14/01 at 15:46 (062983)

What ever classification system that removes double bind studies and removes mutlti-center studies is a big start. I believe that the same classificaion system that ultra sound is used is perfect. This would be a Class one . Pain management would be the proper indication. I do know that
the orbasone system used a class one application and that is why it entered the market so fast. So we have a choice class one , class two, or class three.

We know that two and three take too much time class one is the fastest. I also know that with the orbasone they provided studies showing the lack of damage to bone with high power energy with their specific device. So animal studies would have to be included if the companies wouldn't tell you exactly what the mj/mm2 would at the f2 treatment spot.

In my minde this is so simple. Let the doctors and the universities spent the money to do research on specific condition. This is what is being done every day with surgical procedures. so why not ESWT.

Yes the safety factor would have to be completely answered which I feel it already has but the efficiency factor well that is up to the medical field and the buy can determine this by careful education and comparison

Deos this make senses or am I just making this very simple because in my mind it is simple if you remove the manusfactors from the picture.

Re: Steps to Class 1 success

Scott R on 10/14/01 at 18:03 (062986)

Getting ESWT machines classified as Class 1 probably isn't just a matter of patients sending letters. Having the law on the side of making a machine class 1 is an absolute necessity. First we need to know how the law works in machine classification, then we need a machine that fits those requirements, and then we can petition the FDA.

I don't know how the FDA would view patients trying to make a machine class one when the company wants it class 3. Orbasone's FDA woes would indicate success is unlikely even with the support of the company. Politics is involved only to the extent that other manufacturers can acquire FDA's ear with valid complaints of the FDA allowing unfair competition in violation of its own regulations.

We all have to make a living and few of us have the time to persue avenues that are unlikely to succeed. There is no pot of gold at the end of the rainbow, eventhough many would be helped. This is the key if not only remaining problem with our system of government and economics. Now that Dr. Z and I have gone to the effort of discussing it, maybe someone else will do the legal background work addressing the issues I've mentioned above. http://www.fda.gov is a greatly informative website.

Re: Steps to Class 1 success

Dr. Zuckerman on 10/14/01 at 18:30 (062987)

I agree that the solution isn't simple . Maybe just a letter of support
to reduce the process tot he quickest method and at the same time the safest method possible. I will repeat safety is important and proof of sucess for a specific condition should be left to the medical field.

If I knew how to move forward with this believe me I would I just have
no idea how to do this. I have watched the process up close and see that
what I am saying isn't off the wall it may place companies that are
making ESWT machines stock go down the tubes but that isn't a medical
problem that is a finanical problem . So I hope that someone out there has the same strenght that Scott Roberts has when he came up with heelspurs.com
and that person can lead this fight in the cure for plantara fascia pain.

Are you out there we need you. Time only makes pf worse not better.!!!!!

Re: Steps to Class 1 success

David on 10/15/01 at 11:36 (063007)

I agree that the cost of ESWT treatments right now is prohibitively high. One of the main reasons I believe is that there is no competition right now....the Ossatron being the only FDA approved device out there. Although there are a few Orbasone machines, because of their issues with the FDA, I don't think you'll see an expansion of that device.

Once the low-energy devices become available on the market, possibly by the end of the year, I wouldn't be surprised to see the cost per treatment drop to the hundreds, instead of thousands. These devices, which will be much more affordable, and will not require anesthesia or imaging, and can be done in a doctor's office instead of a surgery center should dominate the market.

Rather than getting the FDA to change their regulatory structure, I think that good old fashioned competition will lower prices rapidly. David

Re: Steps to Class 1 success

Dr. Zuckerman on 10/15/01 at 14:19 (063016)

We have talked about this before David and I hope you are right but I still can't see how the soncur is going to make a big change with the present market structure. Unless I am not understanding the structure the cost of the machines is too high and the ability for the treating doctor to make a fair profit is too low. Very interesting how I will be able to use soncur for plantar fasciitis without it going thru FDA trials. The fact that if did go thru elbow FDA trials and since it did this it is ok to use it for plantar fasciitis treatment is ok but the system in my opinion is wrong and set up to create a lack of competition. The small company who can produce a machine that may be better and cheaper is left out of the picture.

The FDA or use of the FDA by companies is what has created this and so long as it stays this way the price will stay up there.

Re: Steps to Class 1 success and other treatments

Pauline on 10/17/01 at 23:09 (063203)

I think Scott is correct about the law. I remember reading some where that when one medical device is already FDA approved and rated as a Class III device all other medical devices that follow in it's footsteps must also be classified exactly the same. Can't quote it exactly, but I do remember reading something about it.

Another point I'd like information on, is using ESWT as a treatment for neuromas or other foot conditions which were not part of the original FDA application approval usage and for which no studies have been done.

Dr. Jan Rompe who's known for his research with ESWT said in a recent e-mail that he knows of no studies having been done using ESWT to treat neuromas. If this is the case is Healthronics allowing their Ossatron to be used to treat neruomas in patients and what are they charging for this treatment?