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To DR. Z

Posted by Pauline on 4/24/01 at 11:12 (045562)

The ISMST and DIGEST have not been able to provide me with any documentation of studies having been done on the Orbasone machine in Europe. They support the fact that ESWT studies have been underway in Europe for 10 years but not specificly using the Orbasone Machine. The list of manufacturers they provided didn't include MIP or Norland Medical. I am not saying they haven't been done only that these two agencies cannot verify it. Can you reference where the European Orbasone studies were conducted and who did them?

They did say one of their goals is create a international standardized form to be used for surveys, treatments and follow-up studies that will allow multinational assessments of results and collaboration with the industry.

They are asking the manufacturers of shockwave devices to arrive at a common set of shockwave parameters to enable the comparison of the different devices and the treatments given.

It sounds to me like they are very interested in global unity on ESWT, and take their work pretty seriously. They must hold the FDA in fairly high regard because they told me the FDA had recently approved the OssaTron in the U.S. which we of course knew.

Re: To DR. Z

Dr. Zuckerman on 4/24/01 at 11:40 (045566)

The orbasone is called the ossanol in Europe. The studies that I am referring to are from individual doctors that have used the ossanol.

When we talk about standardization did you know that the ossatron is the only company that doesn't list their mj/mm2, Only kv which tells you almost nothing about the treatment at the focal point. Every time that I bring this up there seems to be alot of negative comment and at one time fear that I would built my own machine or something like that . It really doesn't matter because just yesterday I received the complete setting etc for the ossatron. But you tell me why this information was available to the public.

Re: To DR. Z

Pauline on 4/24/01 at 22:44 (045629)

I didn't make myself clear in my posting because I assumed everyone knew the Orbasone was called the Ossanol in Europe. I used that name in my letters and still they did not verify any studies done on that machine. It appears that all the thousands of pages of test results you were refering to was never done on the Orbasone/Ossanol even in Europe. I think the facts show that the Orbasone Machine has never had blinded randomised controled studies done anywhere.

It appears you were refering only to the general fact, that ESWT had been studied for years in Europe and not refering to your specific machine althought that was never said.

For me the statements you leave out turn out to be the most interesting.

Re: To DR. Z

Dr. Zuckerman on 4/25/01 at 08:12 (045649)

I am not sure if there have ever been any controlled, randomized, blinded studies done for any ESWT machines in Europe period.

I was referring to the orbasone when I talked about it use in Europe. I was given a list of doctors using this machine in the beginning. I either talked to them and did see some of their reports of treatment. The reports of treatment were over one year.

I have also compared reports of treatment with some of the doctors in the USA for the orbasone.

Yes you are right there have never been any sham studies for the orbasone. I hope there they will never have to go that route.

Re: To DR. Z

john h on 4/25/01 at 10:26 (045662)

following is a very good URL for general info on ESWT. its history, theory,etc. http://www.eswt-online.com/history.html

i looked at the Norland website and could find no mention of the Ossanol. I could not fine it on an internet search. i emailed Norland to ask if the Orbasone and Ossanol are the same machines.

Eswt is still very much in the developmental stages. It is not yet clearly understood how it works for the treatment of some conditions such as PF. Low Power/High Power is still in debate among doctors. it seems that they are coming around to the thought that multimple treatments-as many as 10-may be required. I think there have been over 50,000 ESWT treatments given in europe with most reporting good to excellent results. there are many machines on the market and most use the spark gap technology as opposed to the piesoelectric. knowing that there have been a miniscule number of reports of adverse reactions i would not worry about using any of the machines. most machines have not gone through the tough FDA certification in the U.S. because of cost. Inurance covers ESWT in europe almost universally. Norland and the FDA are still in some sort of dispute.

Re: To John h

Pauline on 4/25/01 at 13:52 (045681)

Most of the machines have not gone throught the FDA certification because they have not finished the documentation required be included with the application. Dornier is now in the process and orthowave is running their studies and will soon apply. If companies hope to market a Orthotripsy
Machine in the U.S. and not a Therapeutic Vibrator they will apply for FDA approval and soon. When insurance coverage is widely available unless they
have that FDA approval no insurance company including and especially Medicare will pay for the treatment.

You bet Norland and the FDA are in dispute. Its called litigation and the FDA has put Norland's Orbasone/Ossanol in their Automatic Detention List.

Re: To John h

Dr. Zuckerman on 4/25/01 at 19:56 (045735)

How come whirlpool and electric stimulation and other physical therapy treatment are covered by insurance and they don't have PMA applications.

I sat in on an FDA meeting with MIP in the last month and there is no litigation going on. There is only mutual cooperation on the part of MIP and the FDA. So stop with the litigation talk unless your research shows that they now are in one. I doubt it very much. There is no point to it.

By the way no company will and can market an orthotripsy device in the USA because it is a trade word that has been made up for use only by healthronic. Duane E taught that to Dr. Z along time ago.

Re: To Dr. Z

Pauline on 4/25/01 at 22:39 (045759)

Do I detect a stutter.

Re: To Dr. Z

Dr. Zuckerman on 4/25/01 at 23:04 (045763)

Come stop talking out of your feet. Oh by the way how are your feet.

Re: Sorry Pauline

Dr. Zuckerman on 4/25/01 at 23:35 (045771)

I am slow I didn't see the double click stutter. I know I can't spell but speaking that is my forte and well I was mad at you . You really know how to torture me

Re: Sorry Pauline

john h on 4/26/01 at 11:44 (045817)

dr z and others to N.J.: it appears that 3-5 board members will gather at your world headquarter on the 15th. i am very excited to meet some people i feel i have know for some years and exchange war stories. be warned i will be checking out your footware very carefully. make sure you have plenty of those weird spark plugs and the machine is in good working order especially the generator. maybe the biggest gathering since the original canadian group. hope i am first with the ESWT because the machine is going to get real hot with that many treatments. i am doing both feet as before at the same time. make sure you factor that into your schedule. for any of you making the trip you can email me at work john1932@swbell.net and i can give you my cell number so that we make contact. my climbing the tree to get the cat down gave my feet a set back. it was was either the cat or my feet. my biggest rescue since vietnam. if you have never got a cat out of a high tree make sure you wear armour as they do bite and scratch friend and foe alike. my wife was very interested in all my scratch marks.

Re: Sorry Pauline

Dr. Zuckerman on 4/26/01 at 13:48 (045840)

We will be only use the european spark plugs for that day.

Re: To DR. Z

Dr. Zuckerman on 4/24/01 at 11:40 (045566)

The orbasone is called the ossanol in Europe. The studies that I am referring to are from individual doctors that have used the ossanol.

When we talk about standardization did you know that the ossatron is the only company that doesn't list their mj/mm2, Only kv which tells you almost nothing about the treatment at the focal point. Every time that I bring this up there seems to be alot of negative comment and at one time fear that I would built my own machine or something like that . It really doesn't matter because just yesterday I received the complete setting etc for the ossatron. But you tell me why this information was available to the public.

Re: To DR. Z

Pauline on 4/24/01 at 22:44 (045629)

I didn't make myself clear in my posting because I assumed everyone knew the Orbasone was called the Ossanol in Europe. I used that name in my letters and still they did not verify any studies done on that machine. It appears that all the thousands of pages of test results you were refering to was never done on the Orbasone/Ossanol even in Europe. I think the facts show that the Orbasone Machine has never had blinded randomised controled studies done anywhere.

It appears you were refering only to the general fact, that ESWT had been studied for years in Europe and not refering to your specific machine althought that was never said.

For me the statements you leave out turn out to be the most interesting.

Re: To DR. Z

Dr. Zuckerman on 4/25/01 at 08:12 (045649)

I am not sure if there have ever been any controlled, randomized, blinded studies done for any ESWT machines in Europe period.

I was referring to the orbasone when I talked about it use in Europe. I was given a list of doctors using this machine in the beginning. I either talked to them and did see some of their reports of treatment. The reports of treatment were over one year.

I have also compared reports of treatment with some of the doctors in the USA for the orbasone.

Yes you are right there have never been any sham studies for the orbasone. I hope there they will never have to go that route.

Re: To DR. Z

john h on 4/25/01 at 10:26 (045662)

following is a very good URL for general info on ESWT. its history, theory,etc. http://www.eswt-online.com/history.html

i looked at the Norland website and could find no mention of the Ossanol. I could not fine it on an internet search. i emailed Norland to ask if the Orbasone and Ossanol are the same machines.

Eswt is still very much in the developmental stages. It is not yet clearly understood how it works for the treatment of some conditions such as PF. Low Power/High Power is still in debate among doctors. it seems that they are coming around to the thought that multimple treatments-as many as 10-may be required. I think there have been over 50,000 ESWT treatments given in europe with most reporting good to excellent results. there are many machines on the market and most use the spark gap technology as opposed to the piesoelectric. knowing that there have been a miniscule number of reports of adverse reactions i would not worry about using any of the machines. most machines have not gone through the tough FDA certification in the U.S. because of cost. Inurance covers ESWT in europe almost universally. Norland and the FDA are still in some sort of dispute.

Re: To John h

Pauline on 4/25/01 at 13:52 (045681)

Most of the machines have not gone throught the FDA certification because they have not finished the documentation required be included with the application. Dornier is now in the process and orthowave is running their studies and will soon apply. If companies hope to market a Orthotripsy
Machine in the U.S. and not a Therapeutic Vibrator they will apply for FDA approval and soon. When insurance coverage is widely available unless they
have that FDA approval no insurance company including and especially Medicare will pay for the treatment.

You bet Norland and the FDA are in dispute. Its called litigation and the FDA has put Norland's Orbasone/Ossanol in their Automatic Detention List.

Re: To John h

Dr. Zuckerman on 4/25/01 at 19:56 (045735)

How come whirlpool and electric stimulation and other physical therapy treatment are covered by insurance and they don't have PMA applications.

I sat in on an FDA meeting with MIP in the last month and there is no litigation going on. There is only mutual cooperation on the part of MIP and the FDA. So stop with the litigation talk unless your research shows that they now are in one. I doubt it very much. There is no point to it.

By the way no company will and can market an orthotripsy device in the USA because it is a trade word that has been made up for use only by healthronic. Duane E taught that to Dr. Z along time ago.

Re: To Dr. Z

Pauline on 4/25/01 at 22:39 (045759)

Do I detect a stutter.

Re: To Dr. Z

Dr. Zuckerman on 4/25/01 at 23:04 (045763)

Come stop talking out of your feet. Oh by the way how are your feet.

Re: Sorry Pauline

Dr. Zuckerman on 4/25/01 at 23:35 (045771)

I am slow I didn't see the double click stutter. I know I can't spell but speaking that is my forte and well I was mad at you . You really know how to torture me

Re: Sorry Pauline

john h on 4/26/01 at 11:44 (045817)

dr z and others to N.J.: it appears that 3-5 board members will gather at your world headquarter on the 15th. i am very excited to meet some people i feel i have know for some years and exchange war stories. be warned i will be checking out your footware very carefully. make sure you have plenty of those weird spark plugs and the machine is in good working order especially the generator. maybe the biggest gathering since the original canadian group. hope i am first with the ESWT because the machine is going to get real hot with that many treatments. i am doing both feet as before at the same time. make sure you factor that into your schedule. for any of you making the trip you can email me at work john1932@swbell.net and i can give you my cell number so that we make contact. my climbing the tree to get the cat down gave my feet a set back. it was was either the cat or my feet. my biggest rescue since vietnam. if you have never got a cat out of a high tree make sure you wear armour as they do bite and scratch friend and foe alike. my wife was very interested in all my scratch marks.

Re: Sorry Pauline

Dr. Zuckerman on 4/26/01 at 13:48 (045840)

We will be only use the european spark plugs for that day.