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ESWT question

Posted by BrianG on 4/17/01 at 07:53 (044793)

Nothing like waiting until the last minute......
Today, after 7 years, I have an appointment with a new Pod for a 2nd opinion. Among the questions I would like answered, is am I a candidate for ESWT? She is not an ESWT doc, but if I ask her all the right queastions, she should be able to give me the right answers. What information am I looking for? Does anyone have a list? Thanks in advance.

BCG

Re: ESWT question

Dr. Zuckerman on 4/17/01 at hrmin (044802)

Hi,

In summary if the pod feels that pf release is needed then ESWT is an option.

The same clinicial criteria that you would use to determine if pf release is needed is how you determine if ESWT is needed

Re: ESWT question

BrianG on 4/18/01 at 07:49 (044935)

Thank you Dr Z, I got my second opinion. Yes, I do have PF. I was actually hoping it would have been something that could be cured. I guess somebody has to be in that 5% that cannot be cured, Why Me :*(

BCG

Re: ESWT question

Kay S on 4/18/01 at 15:21 (044997)

Brian
Why do you think your pf (or any, for that matter) cannot be cured? And did the second pod say anything about being a candidate for ESWT? If you haven't tried that yet, now is the time to start looking into it. Never give up, Brian!
I have had pf for almost five years and continue to be hopeful that something will come along to give me some relief. Believe me, my whole life has changed drastically, just as yours has, but we cannot give up!
I have read your posts for the past few months and think you have a lot to offer all of us.........lots of good suggestions, lots of support and understanding. It wouldn't be right for you to just bow out of this fight against pf, Brian, and you have a whole lot of people who care about you here on this board, and who certainly understand your frustration.
We all have those moments when it just seems too much to bear, but thankfully our spirits get renewed from time to time, and I hope yours will too.
If I had a team competition against pf, I'd want you on my side.
Kay

Re: I'm still here :*)

BrianG on 4/18/01 at hrmin (045036)

Thanks Kay,

Yes, I am VERY frustrated right now. My new Pod thinks ESWT might be good for me, but she would rather cut, as she is a board certified surgeon. I haven't given up on surgery again, but I will wait for ESWT to come to my area first. I have work and lousy insurance problems right now. Traveling for ESWT is out of the question. So I wait, and wait, and wait. I think I'm looking at least another year. I'll be around, thank you. When we someone coming to the forum in excruciatng pain, I'll still be there for a little advice and some good vibes.

I guess I'm one of the few people here that don't mind seeing some spirited converstion about the machines. It's most likely because I come for information, and a little help now and then. Others want to make this site a nice little family unit. Sorry, but this is an open forum, and will attract all types. If people feel they have to leave, I feel bad they must go running to Scott with their tales of woe. I realize I'm a new comer, and don't want to alienate anyone, but information is what is most important to me. Others who have been here longer, obviously feel different. OK, it's off the soap box now !!

If anyone feels they are at the end of their rope with chronic pain, I'd be glad to help point them in the right direction, towards pain relief.

BCG

Re: I'm still here :*)

Nancy N on 4/19/01 at 09:19 (045072)

Brian--I don't mind 'spirited conversation.' I don't think most of us do (it certainly makes life more interesting!) I do mind nasty, accusatory remarks made during the 'spirited conversation.' There are ways to have intelligent, mature debates that don't involve cutting other people down, but we seem to be in a cycle lately where that seems to be the exception rather than the rule. I may not agree with what you have to say, but I'll defend to the death your right to say it--and I expect that, in return, you won't skewer someone's character in an attempt to make your point.

As for the family unit--We are a community, whether we intended to be or not. We do come here for information, but we also come here for support, and that brings us together as more than info-seekers. We can choose to participate in that community as we see fit, so we're welcome to join in or not, but a support community can only exist where there's respect. That doesn't mean that we're not an open forum; it just means that we are an open forum that should respect each other. I fear that our lack of same has already alienated some of our recent first-time visitors, which is a crying shame.

Re: Am I characrter bashing ?

BrianG on 4/19/01 at 11:00 (045087)

Hi Nancy,

When you say that you expect that I 'won't skewer someone's character in an attempt to make your point' are you talking to me, or just making a generalization? I don't think I've done any character bashing, at least not on purpose.

BCG

PS Are you sure it's the 1st time visitors who are being alientated? Personally I think it's some of Dr. Z's most ardent supporters, which is just as bad. Why do they think they have to leave, why can't they just skip over what they don't like?

Re: No, you're not!

Nancy N on 4/19/01 at 11:17 (045091)

Brian--

I was speaking generally--sorry if I wasn't clear about that. I definitely was not referring to anyone in specific.

I haven't heard much from Tammie lately, or from Ellen, both of whom were new to the board. There are others we may never know about, if they come once, see the madness that's gone on lately, and leave forever without posting at all.

I don't see why we have to talk about Dr. Z's 'supporters'--this isn't a campaign or a popularity contest. The thing is that Dr. Z has been around this board for a very long time and has always eagerly offered his advice and support without cost. There are a lot of people on the board who are very grateful for that, and see some of the comments that were made as attacks on his character and in bad form considering all that Dr. Z does to try to help us (there are several other doctors that do this, too, but they weren't mentioned inthe discussion). That makes it a lot harder to skip over something that someone doesn't 'like,' especially when the feeling is that someone's being attacked unfairly. It's not like skipping a post about trying MSM just because you're not interested in MSM. When things get personal, it's harder to walk away. And I don't think that's entirely unjustified--if nobody did anything about it, like Pauline said in another post, things could get out of hand.

We should both ask the questions we feel should be asked, and stand up for the things we believe in. And it's OK to have different opinions, and to agree to disagree. I just think we can (and should) do that without making things personal and attacking each other.

Re: No, you're not!

BrianG on 4/19/01 at 11:35 (045094)

Tammie has been posting regularly on 'foot surgery'. She just had her surgery this week, and is doing OK, considering it's only been a few days.

BCG

Re: ESWT question

john h on 4/20/01 at 10:11 (045181)

i would think a very important point is there a spot on your foot that you can press on an reproduce Pain? if there is no spot the doctor can focus the very narrow shock wave beam on then you are shooting in the dark. my spot is just forward fo the heel on the inside edge of the foot which seems to be the classic place for PF to appear.

Re: No, you're not!

ellen w on 4/20/01 at 19:12 (045230)

Hi Nancy, and hello to others also,

I haven't been on this board much mostly because I've been extremely busy at work -- it's quarter to eight, Friday night -- and I'm still here -- and have only been reading the products and social boards. I jumped to the ESWT site only after seeing the argument referred to on these boards. I am actually doing extremely well and have been meaning to post on it, and the fact that I think MSM has helped.

Re. this discussion, I will add that discussion is good, attacks not good. And this: how many people on this board have had an MRI? How many have asked in advance whether the MRI machine being used is made by GE or Fonar? How many patients even know that there are different MRI manufacturers, and that the doctors and administrators who make the purchase decisions use their own set of clinical experiences/standards as well as business management plans to make decisions between which manufacturer's device to use.

My point is that ultimately the medical market and insurance reimbursement will settle out the issue of whether Orbasone or OssaTron, or another device is best...as well as clinical studies. What patients should be asking is, one, whether their insurance will pay for it, and two, what experience has the person administering the treatment had with the device?

I do have one question for Dr. Z (who I think is great by the way). Is there any chance that you could participate in clinical trials of the Orbasone? Or develop one yourself in connection with an academic medical center? And you should probably consider writing up your experiences for publication.

Ellen

Re: No, you're not!

Pauline on 4/22/01 at 11:55 (045353)

Ellen,
I disagree with some of what you said, because the manufacturer and capability of the machine is important and simply because some people never ask does not mean this is not true. I will tell you when I have my mamography I do ask the center which machine they are using because one machine produces better, clearer images. Many people do not keep current with new medical developments that take place and are not aware that one machine is certainly better than another and they should go where the latest technologically advanced machine is located.

With the Orbasone and OssaTron the main part of our discussion is centered around FDA approval for the machine to be used to treat P.F. in the U.S.

Here are things we know:

Ossatron:

Manufacturered by Healthronics
High Power Machine
Granted full FDA approval in Oct, 2000 to be used to treat Plantar Fasciitis in the U.S.
Must be used in a Surgical Setting
Physician must have training I believe Healthronics is providing the training.
I.V. Sedation used during treatment
Reports required by Healthronics from practitioners
FDA requiring continuted postapproval studies be done on 300 patients annually to study nurological and long term follow up.
Additional studies required to treat other Soft tissue diseases

Orbasone:

Manufacturered by MIP (distrubuted by Norland Medical in U.S.)
High Power Machine with possible options per Dr.Z
European studies conducted as indicated by Dr.Z
No FDA approval to be used to treat Plantar Fasciitis in the U.S.
Currently listed on the FDA Import Detainment list because it lacks either a filed 510 (K) or approved PMA (pre market approval) for commercial distribution.
Norland Medical has currently stopped marketing the Orbasone.

** I have confirmed with 2 individual sources the lack of FDA approval and the FDA Import Detainment List. One through the FDA and the other an independent research firm called FDC Reports Inc/ Library Research in Chevy Chase MD. Each produced the same results ( No FDA Approval Granted)
and on the list.

Knowing these facts ahead of time may be of very important to some patients who are considering having ESWT treatment. If the machine was going to be used to treat their eyes maybe having an FDA approval might be more meaningful. Lasix surgery machines carry FDA approval. Why? I think it's all too often people think 'After all it's just my feet, what could happen with feet?

Although Dr. Z. loves his Orbasone machine and defends it to the bottom of his soul which he certainly has a right to do, the fact remains that no FDA studies have been conducted in the U.S. as to the safety and effectiveness of the Orbasone machine. This is not to say it is not safe or effective, but simply to point out that to date the FDA has no studies submitted by Norland to support the safety and effectiveness of the Orbasone machine to treat Plantar Fasciitis.

For myself, I choose to rely on the scientific facts that are provided by the FDA here in the U.S. and I think it is ok for Dr.Z and me to disagree on this subject. It doesn't make either of us bad guys. For better or worse the FDA's job is to provide a safety net for patients, by evualuating and approving equipment comming into this country that will be used to treat various medical conditions. To some people this may make a difference, others may not care, but all have a right to be informed.

Re: No, you're not!

Dr. Zuckerman on 4/22/01 at 15:58 (045372)

You forgot the 510k application that was submitted but will probaby be disallowed in my opinion.

Re: To Dr. Z No, you're not!

Pauline on 4/23/01 at 07:33 (045411)

Dr. Z,
Both you and I know that the original 501(5) application submitted by Norland to the FDA was only in a classification that would allow them to
label and market the Orbasone as a Therpeutic Vibrator not to treat Specific Soft tissue Diseases including Plantar Fasciitis.

You cannot apply for approval in one classification then switch the use of the machine to another purpose and market it. This was in my opinion a sneeky dishonest approach by Norland which didn't work.

They wanted to capture the market first, but didn't want to take the time to run the studies. That doesn't say much for a company who knew the ropes and their machine ended up on the FDA's Automatic Detention List. No complience no marketing

Re: To Dr. Z No, you're not!

Pauline on 4/23/01 at 07:36 (045412)

Miss tpye ---meant 501(K)

Re: No, you're not!

ellen w on 4/23/01 at 09:23 (045424)

Hi Pauline,

I thought that was a very effective, thoughtful, summary, and really helped frame the discussion. My direct experience with medical devices has been limited; but my experience has been that though different machines have different capacities, the skill of the doctor/technician in doing the test and reading the results is as important and perhaps more important than the machine used. Of the 2 mammograms I had done, same center, same machine, the first was very painful and had to be redone, thanks to a klutzy technician. The second, painless and no problems. With my MRI, the technician refused to do the procedure due to all the metal (pins, plate, screws) in my ankle, and I had to wait until a physician was available to ensure that a good reading was done. In some ways, we're making the same point -- that clinical experience is important.

Re: To Dr. Z No, you're not!

Dr. Zuckerman on 4/23/01 at 19:10 (045502)

First of all I didn't even know what any of the classifications were when I started using the orbasone. I was shown the approval letter from the FDA for the use of the orbasone and that was it. Of course I knew exactly how ESWT worked and what settings should be used. There were even calls to the FDA in the beginning and we were told that the orbasone is cleared for market.

Now I find out that the all sides involved knew what the orbasone was and still cleared it for the USA market. Only after they cleard a machine that they clearly knew what it was did market pressures come to arms.

My understanding of the problem with improper marketing came from the Norland sales force telling doctors what specific parts of the body they could use this machine for when the FDA clearance stated that they could only tell doctors that the machine was for pain management. This if true is clearly against the FDA clearance for the orbasone.

There is alot more to this story which I have heard but haven't had the time to vertify. Believe there are more people involved in this story .

What if a company such as Norland Medical takes a look at a product and determines thru consultants that in deed the orbasone is a class one device and then tells the regulatory body that this is what they have and the regulatory body tells them ok this is ok and then after the machine is on the market turns 360 degree around.

My own personal opinon is that all of these devices are class one devices and that Norland is correct in their thinking but you have to go ahead and do a PMA due to the market pressure. You see it Norland is right then someone has to be wrong. and then alot of money will be lost.

So someone's consultant is wrong and someone Consultant is right. In this case the public is the real loser.

So what else is there to say about the orbasone and that hasn't been talked about.

Re: ESWT question

Dr. Zuckerman on 4/17/01 at hrmin (044802)

Hi,

In summary if the pod feels that pf release is needed then ESWT is an option.

The same clinicial criteria that you would use to determine if pf release is needed is how you determine if ESWT is needed

Re: ESWT question

BrianG on 4/18/01 at 07:49 (044935)

Thank you Dr Z, I got my second opinion. Yes, I do have PF. I was actually hoping it would have been something that could be cured. I guess somebody has to be in that 5% that cannot be cured, Why Me :*(

BCG

Re: ESWT question

Kay S on 4/18/01 at 15:21 (044997)

Brian
Why do you think your pf (or any, for that matter) cannot be cured? And did the second pod say anything about being a candidate for ESWT? If you haven't tried that yet, now is the time to start looking into it. Never give up, Brian!
I have had pf for almost five years and continue to be hopeful that something will come along to give me some relief. Believe me, my whole life has changed drastically, just as yours has, but we cannot give up!
I have read your posts for the past few months and think you have a lot to offer all of us.........lots of good suggestions, lots of support and understanding. It wouldn't be right for you to just bow out of this fight against pf, Brian, and you have a whole lot of people who care about you here on this board, and who certainly understand your frustration.
We all have those moments when it just seems too much to bear, but thankfully our spirits get renewed from time to time, and I hope yours will too.
If I had a team competition against pf, I'd want you on my side.
Kay

Re: I'm still here :*)

BrianG on 4/18/01 at hrmin (045036)

Thanks Kay,

Yes, I am VERY frustrated right now. My new Pod thinks ESWT might be good for me, but she would rather cut, as she is a board certified surgeon. I haven't given up on surgery again, but I will wait for ESWT to come to my area first. I have work and lousy insurance problems right now. Traveling for ESWT is out of the question. So I wait, and wait, and wait. I think I'm looking at least another year. I'll be around, thank you. When we someone coming to the forum in excruciatng pain, I'll still be there for a little advice and some good vibes.

I guess I'm one of the few people here that don't mind seeing some spirited converstion about the machines. It's most likely because I come for information, and a little help now and then. Others want to make this site a nice little family unit. Sorry, but this is an open forum, and will attract all types. If people feel they have to leave, I feel bad they must go running to Scott with their tales of woe. I realize I'm a new comer, and don't want to alienate anyone, but information is what is most important to me. Others who have been here longer, obviously feel different. OK, it's off the soap box now !!

If anyone feels they are at the end of their rope with chronic pain, I'd be glad to help point them in the right direction, towards pain relief.

BCG

Re: I'm still here :*)

Nancy N on 4/19/01 at 09:19 (045072)

Brian--I don't mind 'spirited conversation.' I don't think most of us do (it certainly makes life more interesting!) I do mind nasty, accusatory remarks made during the 'spirited conversation.' There are ways to have intelligent, mature debates that don't involve cutting other people down, but we seem to be in a cycle lately where that seems to be the exception rather than the rule. I may not agree with what you have to say, but I'll defend to the death your right to say it--and I expect that, in return, you won't skewer someone's character in an attempt to make your point.

As for the family unit--We are a community, whether we intended to be or not. We do come here for information, but we also come here for support, and that brings us together as more than info-seekers. We can choose to participate in that community as we see fit, so we're welcome to join in or not, but a support community can only exist where there's respect. That doesn't mean that we're not an open forum; it just means that we are an open forum that should respect each other. I fear that our lack of same has already alienated some of our recent first-time visitors, which is a crying shame.

Re: Am I characrter bashing ?

BrianG on 4/19/01 at 11:00 (045087)

Hi Nancy,

When you say that you expect that I 'won't skewer someone's character in an attempt to make your point' are you talking to me, or just making a generalization? I don't think I've done any character bashing, at least not on purpose.

BCG

PS Are you sure it's the 1st time visitors who are being alientated? Personally I think it's some of Dr. Z's most ardent supporters, which is just as bad. Why do they think they have to leave, why can't they just skip over what they don't like?

Re: No, you're not!

Nancy N on 4/19/01 at 11:17 (045091)

Brian--

I was speaking generally--sorry if I wasn't clear about that. I definitely was not referring to anyone in specific.

I haven't heard much from Tammie lately, or from Ellen, both of whom were new to the board. There are others we may never know about, if they come once, see the madness that's gone on lately, and leave forever without posting at all.

I don't see why we have to talk about Dr. Z's 'supporters'--this isn't a campaign or a popularity contest. The thing is that Dr. Z has been around this board for a very long time and has always eagerly offered his advice and support without cost. There are a lot of people on the board who are very grateful for that, and see some of the comments that were made as attacks on his character and in bad form considering all that Dr. Z does to try to help us (there are several other doctors that do this, too, but they weren't mentioned inthe discussion). That makes it a lot harder to skip over something that someone doesn't 'like,' especially when the feeling is that someone's being attacked unfairly. It's not like skipping a post about trying MSM just because you're not interested in MSM. When things get personal, it's harder to walk away. And I don't think that's entirely unjustified--if nobody did anything about it, like Pauline said in another post, things could get out of hand.

We should both ask the questions we feel should be asked, and stand up for the things we believe in. And it's OK to have different opinions, and to agree to disagree. I just think we can (and should) do that without making things personal and attacking each other.

Re: No, you're not!

BrianG on 4/19/01 at 11:35 (045094)

Tammie has been posting regularly on 'foot surgery'. She just had her surgery this week, and is doing OK, considering it's only been a few days.

BCG

Re: ESWT question

john h on 4/20/01 at 10:11 (045181)

i would think a very important point is there a spot on your foot that you can press on an reproduce Pain? if there is no spot the doctor can focus the very narrow shock wave beam on then you are shooting in the dark. my spot is just forward fo the heel on the inside edge of the foot which seems to be the classic place for PF to appear.

Re: No, you're not!

ellen w on 4/20/01 at 19:12 (045230)

Hi Nancy, and hello to others also,

I haven't been on this board much mostly because I've been extremely busy at work -- it's quarter to eight, Friday night -- and I'm still here -- and have only been reading the products and social boards. I jumped to the ESWT site only after seeing the argument referred to on these boards. I am actually doing extremely well and have been meaning to post on it, and the fact that I think MSM has helped.

Re. this discussion, I will add that discussion is good, attacks not good. And this: how many people on this board have had an MRI? How many have asked in advance whether the MRI machine being used is made by GE or Fonar? How many patients even know that there are different MRI manufacturers, and that the doctors and administrators who make the purchase decisions use their own set of clinical experiences/standards as well as business management plans to make decisions between which manufacturer's device to use.

My point is that ultimately the medical market and insurance reimbursement will settle out the issue of whether Orbasone or OssaTron, or another device is best...as well as clinical studies. What patients should be asking is, one, whether their insurance will pay for it, and two, what experience has the person administering the treatment had with the device?

I do have one question for Dr. Z (who I think is great by the way). Is there any chance that you could participate in clinical trials of the Orbasone? Or develop one yourself in connection with an academic medical center? And you should probably consider writing up your experiences for publication.

Ellen

Re: No, you're not!

Pauline on 4/22/01 at 11:55 (045353)

Ellen,
I disagree with some of what you said, because the manufacturer and capability of the machine is important and simply because some people never ask does not mean this is not true. I will tell you when I have my mamography I do ask the center which machine they are using because one machine produces better, clearer images. Many people do not keep current with new medical developments that take place and are not aware that one machine is certainly better than another and they should go where the latest technologically advanced machine is located.

With the Orbasone and OssaTron the main part of our discussion is centered around FDA approval for the machine to be used to treat P.F. in the U.S.

Here are things we know:

Ossatron:

Manufacturered by Healthronics
High Power Machine
Granted full FDA approval in Oct, 2000 to be used to treat Plantar Fasciitis in the U.S.
Must be used in a Surgical Setting
Physician must have training I believe Healthronics is providing the training.
I.V. Sedation used during treatment
Reports required by Healthronics from practitioners
FDA requiring continuted postapproval studies be done on 300 patients annually to study nurological and long term follow up.
Additional studies required to treat other Soft tissue diseases

Orbasone:

Manufacturered by MIP (distrubuted by Norland Medical in U.S.)
High Power Machine with possible options per Dr.Z
European studies conducted as indicated by Dr.Z
No FDA approval to be used to treat Plantar Fasciitis in the U.S.
Currently listed on the FDA Import Detainment list because it lacks either a filed 510 (K) or approved PMA (pre market approval) for commercial distribution.
Norland Medical has currently stopped marketing the Orbasone.

** I have confirmed with 2 individual sources the lack of FDA approval and the FDA Import Detainment List. One through the FDA and the other an independent research firm called FDC Reports Inc/ Library Research in Chevy Chase MD. Each produced the same results ( No FDA Approval Granted)
and on the list.

Knowing these facts ahead of time may be of very important to some patients who are considering having ESWT treatment. If the machine was going to be used to treat their eyes maybe having an FDA approval might be more meaningful. Lasix surgery machines carry FDA approval. Why? I think it's all too often people think 'After all it's just my feet, what could happen with feet?

Although Dr. Z. loves his Orbasone machine and defends it to the bottom of his soul which he certainly has a right to do, the fact remains that no FDA studies have been conducted in the U.S. as to the safety and effectiveness of the Orbasone machine. This is not to say it is not safe or effective, but simply to point out that to date the FDA has no studies submitted by Norland to support the safety and effectiveness of the Orbasone machine to treat Plantar Fasciitis.

For myself, I choose to rely on the scientific facts that are provided by the FDA here in the U.S. and I think it is ok for Dr.Z and me to disagree on this subject. It doesn't make either of us bad guys. For better or worse the FDA's job is to provide a safety net for patients, by evualuating and approving equipment comming into this country that will be used to treat various medical conditions. To some people this may make a difference, others may not care, but all have a right to be informed.

Re: No, you're not!

Dr. Zuckerman on 4/22/01 at 15:58 (045372)

You forgot the 510k application that was submitted but will probaby be disallowed in my opinion.

Re: To Dr. Z No, you're not!

Pauline on 4/23/01 at 07:33 (045411)

Dr. Z,
Both you and I know that the original 501(5) application submitted by Norland to the FDA was only in a classification that would allow them to
label and market the Orbasone as a Therpeutic Vibrator not to treat Specific Soft tissue Diseases including Plantar Fasciitis.

You cannot apply for approval in one classification then switch the use of the machine to another purpose and market it. This was in my opinion a sneeky dishonest approach by Norland which didn't work.

They wanted to capture the market first, but didn't want to take the time to run the studies. That doesn't say much for a company who knew the ropes and their machine ended up on the FDA's Automatic Detention List. No complience no marketing

Re: To Dr. Z No, you're not!

Pauline on 4/23/01 at 07:36 (045412)

Miss tpye ---meant 501(K)

Re: No, you're not!

ellen w on 4/23/01 at 09:23 (045424)

Hi Pauline,

I thought that was a very effective, thoughtful, summary, and really helped frame the discussion. My direct experience with medical devices has been limited; but my experience has been that though different machines have different capacities, the skill of the doctor/technician in doing the test and reading the results is as important and perhaps more important than the machine used. Of the 2 mammograms I had done, same center, same machine, the first was very painful and had to be redone, thanks to a klutzy technician. The second, painless and no problems. With my MRI, the technician refused to do the procedure due to all the metal (pins, plate, screws) in my ankle, and I had to wait until a physician was available to ensure that a good reading was done. In some ways, we're making the same point -- that clinical experience is important.

Re: To Dr. Z No, you're not!

Dr. Zuckerman on 4/23/01 at 19:10 (045502)

First of all I didn't even know what any of the classifications were when I started using the orbasone. I was shown the approval letter from the FDA for the use of the orbasone and that was it. Of course I knew exactly how ESWT worked and what settings should be used. There were even calls to the FDA in the beginning and we were told that the orbasone is cleared for market.

Now I find out that the all sides involved knew what the orbasone was and still cleared it for the USA market. Only after they cleard a machine that they clearly knew what it was did market pressures come to arms.

My understanding of the problem with improper marketing came from the Norland sales force telling doctors what specific parts of the body they could use this machine for when the FDA clearance stated that they could only tell doctors that the machine was for pain management. This if true is clearly against the FDA clearance for the orbasone.

There is alot more to this story which I have heard but haven't had the time to vertify. Believe there are more people involved in this story .

What if a company such as Norland Medical takes a look at a product and determines thru consultants that in deed the orbasone is a class one device and then tells the regulatory body that this is what they have and the regulatory body tells them ok this is ok and then after the machine is on the market turns 360 degree around.

My own personal opinon is that all of these devices are class one devices and that Norland is correct in their thinking but you have to go ahead and do a PMA due to the market pressure. You see it Norland is right then someone has to be wrong. and then alot of money will be lost.

So someone's consultant is wrong and someone Consultant is right. In this case the public is the real loser.

So what else is there to say about the orbasone and that hasn't been talked about.