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Response from FDA

Posted by Scott R on 3/15/02 at 20:26 (076552)

March 12, 2002
From FDA, Center for Devices and Radiological Health
To Scott Roberts, heelspurs.com

Dear Mr. Roberts,

On November 29th, 2001, the Food and Drug Administration (FDA) wrote to you regarding the promotional activities for an unapproved device, the OrbasoneTM, on your website. On December 7th, 2001, you responded to the FDA letter by stating that you had removed the promotional material for the OrbasoneTM device from your website. You stated that this promotional material included the removal of all references to the OrbasoneTM device, placement of a block on the word OrbasoneTM and removal of the treatment locations entered into the public database you maintained on your website. Thank you for your prompt compliance with the Federal Food Drug and Cosmetic Act (the Act).

In your letter and additional e-mail correspondence addressed to Erin Keith, you have commented on several issues and have asked for guidance on your website content. First, you have asked for information regarding legally marketed ESWT devices for orthopedic indications (a.k.a., orthotriptor). There are currently two approved orthotriptor devices. These devices are the Healthtronics' OssaTronTM and the Dornier Medtech's Epos UltraTM. These devices are approved for the following indications for use:

'The OssaTronTM is indicated for use for performing extracorporeal shock wave (ESW) treatment in patients with chronic promixal plantar fasciitis that has failed to respond to conservative treatment. Chronic proximal plantar fasciitis is defined as heel pain in the area of the insertion of the plantar fascia on the medial calcaneal tuberosity that has persisted for 6 months or more.'

'The Epos UltraTM is a non-surgical alternative for the treatment of chronic plantar fasciitis for patients with symptoms of plantar faciitis for 6 months or more and a history of unsuccessful conservative therapy. Plantar faciitis is defined as the traction degeneration of the plantar facial band at its origin on the medial tubercle of the calcaneous.'

At this time, all other orthotriptors can only be promoted as experimental and used under an approved investigational device exemption in the United States (U.S.).

Second, you expressed concern over the way the FDA quoted a section of your website in our November 29th, 2001, letter. You were concerned that the FDA was implying that you had fabricated the quote attributed to the FDA on your website. We want to assure you that the FDA does not believe that you fabricated the quote previously attributed to the FDA on your website. The intent of our previous letter was to inform you that your representation of the legal status of the OrbasoneTM was misleading because of further actions by the FDA that rescinded the decision reflected in the material on your website. We regret any confusion our letter may have caused you in this matter.

Third, a you have asked for guidance concerning advertising material that you would like to place on your website. The advertising material would read:

'Because of the expense of being treated in the U.S. some patients are traveling to Canada to be treated at Bayshore Pain Clinics using ESWT machines that may not have FDA approval. Bayshore caters to U. S. citizens. They provide up to 8 treatments and 5 nights in a nearby hotel for two people. Their fee depends on the number of treatments but is always less than $1,500.'

In general, all advertisements must accurately reflect the U.S. marketing status of the device(s) involved. This proposed advertisement appears to accurately reflect the marketing status of the ESWT treatment it promotes.

Finally, you stated that you would like to relist the names of the doctors who were previously on your website as providers of OrbasoneTM treatments. Listing the names of doctors who use a misbranded and adulterated device is illegal promotion of the device, and as such a violation of the act. The OrbasoneTM is considered an investigational device. It can only be used under an approved IDE.

The law does not prohibit the discussion or promotion of investigational devices. It does require that promotional activities for any device accurately reflect the device's legal status in the U.S. Therefore, it would be possible to list any doctor or clinical site in the U.S. participating in an FDA approved clinical study of the or the OrbasoneTM device, as long as use of device is accurately promoted as investigational.

The FDA reminds you that you are responsible for assuring that the promotional material on your website accurately reflects the legal status of the devices in the U.S. If you have any questions regarding this matter please contact Erin Keith at (301) 594-4659 extension 117.

Sincerely Yours,
(signed name something like 'Donald W Serra for')
Gladys Rodrigues
Acting Director
Division of Enforement III
Office of Compliance
Center for Devices and Radiological Health

Re: Response from FDA

Scott R on 3/15/02 at 20:41 (076553)

Don't use the word 'orbas0ne in posts because i still have a block on it, and after just typing and losing a long message, i've learned my programming does a nasty erasure of messages if you have to click 'back'.

Re: Response from FDA

BrianJ on 3/16/02 at 09:29 (076566)

Scott --

It's interesting that the Dornier machine is approved for PF treatment in the U.S. To my knowledge, no doctors in the U.S. are currently treating PF with the Dornier. Can you clarify this? The reason I ask is that the Dornier's treatment from the medial side of the foot seems to make more sense (at least to a layperson) than the OssaTron's treatment from the plantar side of the foot, for those of us with a larger area of pain. In other words, shooting the shockwaves from the side (i.e., across the fascia) will treat a larger area of the fascia than shooting them from the bottom. Plus, shooting from the side minimizes the chance of hitting the heel bone and causing more pain. I realize that some of this post is just parroting the good comments from our friend in Australia, but I'd like to get more info on these points.

Re: Response from FDA

DR Zuckerman on 3/16/02 at 10:04 (076568)

I will try to answer these questions. Shooting from the side could make it less likely to hit the bone and cause temporary pain that is the selling point. The shape of the shockwave is a longer cigar shape when shooting at lower energy. At higher energy the shape is shorter or fatter. On top of this the penetration is going to determine just how far you cross the pf plantar suface to the lateral side. I believe that are picture either on this site or on the site for the international Society for shockwave therapy.

It is my opinion that the has alot of advantages over the ossatron at this time.The inline ultrasound could be very helpful for diagnosic and for localization of the f2 site. The control of pulses per minutes is a very good feature.

In the end and from my experience the result is going to be highly depend on the experience, innovation, and the treating of the ESWT doctor.
Very interesting that the international society of shockwave therapy makes this point when they say the sucess is dependent on the training, experience of the doctor.

Re: Response from FDA

John h on 3/16/02 at 11:08 (076572)

One of Allan's major points Brian is the 'accumulative' effect of the three treatments spread one week apart. I am particularly interested in his approach that in difficult cases they give a steriod shot after treatment as the fasica is more receptive to steriods due to the accumulative effect of the shock waves. I wonder if there has been any thouhgt by the manufacturers to look into moving treatments closer together with other machines. In Canada they do the Dornier every other day for three treatments and I am thinking the Sonnocur in Canada may be on successive days.

Re: Response from FDA

John h on 3/16/02 at 11:12 (076573)

Dr Z if experience is a major factor then you must be Lord of The Rings when it comes to ESWT. I will assure you experience is 'it' when it comes to flying an airplane. When you see your grey headed Capitan on your airline you can be assured he has probably been faced with just about every type of emergency and survived it but if you see Harm Rabb hop out of the Capitans seat it is not the same.

Re: Response from FDA

wendyn on 3/16/02 at 13:30 (076583)

Scott - so basically does this mean that freedom of speech here is okay - as long as you are careful with any promotional information you put on the web?

Re: Response from FDA

John h on 3/16/02 at 15:11 (076590)

only as long as you do not say O-------!

Re: Response from FDA

Scott R on 3/16/02 at 15:38 (076592)

It can't be 'promoted' here, meaning we shouldn't let people know where they can be treated. Eventhough it's legally cloudy, I'll assume I am responsible if somenoe else posts promotional material. They didn't directly answer my question about whether or not we can discuss it or if I'm required to boot people for bypassing the blocks. They didn't answer because if they has said yes I have to boot people, then they would have been in deep doo-doo. If they would have said 'no' that i don't have to boot people, then it wuold have given free reign to discussion. As it is, they just leave open the possibility of me being held liable for other people's posts. I have the legal authority to limit free speech here, they do not, so that's why they threaten me by not answering the question in order to prevent freedom of speech here.

Re: Response from FDA

Scott R on 3/16/02 at 16:16 (076593)

It can't be 'promoted' here, meaning I shouldn't let people know where they can be treated. Eventhough it's not legally clear, I'll assume I am responsible if somenoe else posts promotional material. They didn't directly answer my question about whether or not I'm required to boot people for bypassing the blocks. They didn't answer because if they had said 'yes you have to boot people for discussing it', then they could have been in deep doo-doo for limiting free speech. If they would have said 'no you don't have to boot people', then it would have given free reign to discussion. As it is, they just leave open the possibility of holding me responsible for other people's posts, depending on if they interpret the posts as discussion or promotion. But they didn't mention their position on the message board, meaning they may not legally be able to do anything about free discussion in the message board and don't want to get in trouble by mentioning it, but still may try to hold me liable in the future. It appears they're OK with us discussing it, it's just that it can't be promoted. The law, I believe, means only those with a financial conection to the Orbasone are not allowed to promote it, but they're extending this to me, and not answering my question of if it extends to my visitors, or if I'm responsible for my visitors, although indirectly they seem to be saying i am responsible for my visitors. It may be possible to extend it to me if in some way the website indirectly benefits from the Orbasone being promoted, but extending their regulations to holding me responsible if Joe Schmo starts saying where it can be found in a public forum is legally murky. The question is, 'is it a truly free and open public forum'? If it is then I'm not responsible, or not as responsible. The answer is no, it is no longer a free and public forum thanks to our two friends last year and the response we felt was ecessary I censored posts thereby making it a non-public forum. I have the legal authority to limit free speech here, the FDA does not, so that's why they threaten me by not answering the question in order to prevent other's freedom of speech here.

Re: Response from FDA

Scott R on 3/16/02 at 16:24 (076594)

Maybe someone could call Erin and ask her if i'm responsible for their posts. :)

Re: Response from FDA

BrianJ on 3/16/02 at 17:58 (076598)

John H --

As an aside, I must say I pay particular attention to your comments because of your background as a military pilot. My dad flew Corsairs, B-25s, F9Fs, F-8 Crusaders and such in the Marines, and I know that pilots tend to be analytical and bottom-line oriented. Keep up the good work.

Re: Re:Is that what you wnat me to do

DR Zuckerman on 3/17/02 at 10:09 (076636)

IS that what you wnat me to do . I will if you want me too.

Re: Re:Is that what you wnat me to do

Scott R on 3/17/02 at 10:50 (076637)

Dr Z, I was talking about patients who don't have a financial connection to the big O. They would be the least subject to FDA regulations.

Re: Response from FDA

Allan G on 3/17/02 at 21:13 (076692)

Hi again
Your comments are pretty correct. I thank you for the consideration of my comments as they come with 3 years of ESWT experience.
Regards Allan G

Re: cost of treatment

Teresa M on 7/15/02 at 17:15 (089710)

Inquiring if the prices quoted of $1,500 in Canada for treatment and rooms are current or out dated and if outdated what current prices are for treatment?
Thank you.

Re: cost of treatment

Sunny Jacob - Bayshore on 7/16/02 at 06:09 (089749)

Teresa,
I assume you are referring to Bayshore ESWT clinics.
Bayshore's treatment cost (3 sessions done on alternate days) is $US 1,050.
Hotel room (Hilton) is $US 80/night; this is a special rate for Bayshore patients.
Please contact Cori Liuzzi at (email removed) for scheduling an appointment and other details.

Re: Response from FDA

Scott R on 3/15/02 at 20:41 (076553)

Don't use the word 'orbas0ne in posts because i still have a block on it, and after just typing and losing a long message, i've learned my programming does a nasty erasure of messages if you have to click 'back'.

Re: Response from FDA

BrianJ on 3/16/02 at 09:29 (076566)

Scott --

It's interesting that the Dornier machine is approved for PF treatment in the U.S. To my knowledge, no doctors in the U.S. are currently treating PF with the Dornier. Can you clarify this? The reason I ask is that the Dornier's treatment from the medial side of the foot seems to make more sense (at least to a layperson) than the OssaTron's treatment from the plantar side of the foot, for those of us with a larger area of pain. In other words, shooting the shockwaves from the side (i.e., across the fascia) will treat a larger area of the fascia than shooting them from the bottom. Plus, shooting from the side minimizes the chance of hitting the heel bone and causing more pain. I realize that some of this post is just parroting the good comments from our friend in Australia, but I'd like to get more info on these points.

Re: Response from FDA

DR Zuckerman on 3/16/02 at 10:04 (076568)

I will try to answer these questions. Shooting from the side could make it less likely to hit the bone and cause temporary pain that is the selling point. The shape of the shockwave is a longer cigar shape when shooting at lower energy. At higher energy the shape is shorter or fatter. On top of this the penetration is going to determine just how far you cross the pf plantar suface to the lateral side. I believe that are picture either on this site or on the site for the international Society for shockwave therapy.

It is my opinion that the has alot of advantages over the ossatron at this time.The inline ultrasound could be very helpful for diagnosic and for localization of the f2 site. The control of pulses per minutes is a very good feature.

In the end and from my experience the result is going to be highly depend on the experience, innovation, and the treating of the ESWT doctor.
Very interesting that the international society of shockwave therapy makes this point when they say the sucess is dependent on the training, experience of the doctor.

Re: Response from FDA

John h on 3/16/02 at 11:08 (076572)

One of Allan's major points Brian is the 'accumulative' effect of the three treatments spread one week apart. I am particularly interested in his approach that in difficult cases they give a steriod shot after treatment as the fasica is more receptive to steriods due to the accumulative effect of the shock waves. I wonder if there has been any thouhgt by the manufacturers to look into moving treatments closer together with other machines. In Canada they do the Dornier every other day for three treatments and I am thinking the Sonnocur in Canada may be on successive days.

Re: Response from FDA

John h on 3/16/02 at 11:12 (076573)

Dr Z if experience is a major factor then you must be Lord of The Rings when it comes to ESWT. I will assure you experience is 'it' when it comes to flying an airplane. When you see your grey headed Capitan on your airline you can be assured he has probably been faced with just about every type of emergency and survived it but if you see Harm Rabb hop out of the Capitans seat it is not the same.

Re: Response from FDA

wendyn on 3/16/02 at 13:30 (076583)

Scott - so basically does this mean that freedom of speech here is okay - as long as you are careful with any promotional information you put on the web?

Re: Response from FDA

John h on 3/16/02 at 15:11 (076590)

only as long as you do not say O-------!

Re: Response from FDA

Scott R on 3/16/02 at 15:38 (076592)

It can't be 'promoted' here, meaning we shouldn't let people know where they can be treated. Eventhough it's legally cloudy, I'll assume I am responsible if somenoe else posts promotional material. They didn't directly answer my question about whether or not we can discuss it or if I'm required to boot people for bypassing the blocks. They didn't answer because if they has said yes I have to boot people, then they would have been in deep doo-doo. If they would have said 'no' that i don't have to boot people, then it wuold have given free reign to discussion. As it is, they just leave open the possibility of me being held liable for other people's posts. I have the legal authority to limit free speech here, they do not, so that's why they threaten me by not answering the question in order to prevent freedom of speech here.

Re: Response from FDA

Scott R on 3/16/02 at 16:16 (076593)

It can't be 'promoted' here, meaning I shouldn't let people know where they can be treated. Eventhough it's not legally clear, I'll assume I am responsible if somenoe else posts promotional material. They didn't directly answer my question about whether or not I'm required to boot people for bypassing the blocks. They didn't answer because if they had said 'yes you have to boot people for discussing it', then they could have been in deep doo-doo for limiting free speech. If they would have said 'no you don't have to boot people', then it would have given free reign to discussion. As it is, they just leave open the possibility of holding me responsible for other people's posts, depending on if they interpret the posts as discussion or promotion. But they didn't mention their position on the message board, meaning they may not legally be able to do anything about free discussion in the message board and don't want to get in trouble by mentioning it, but still may try to hold me liable in the future. It appears they're OK with us discussing it, it's just that it can't be promoted. The law, I believe, means only those with a financial conection to the Orbasone are not allowed to promote it, but they're extending this to me, and not answering my question of if it extends to my visitors, or if I'm responsible for my visitors, although indirectly they seem to be saying i am responsible for my visitors. It may be possible to extend it to me if in some way the website indirectly benefits from the Orbasone being promoted, but extending their regulations to holding me responsible if Joe Schmo starts saying where it can be found in a public forum is legally murky. The question is, 'is it a truly free and open public forum'? If it is then I'm not responsible, or not as responsible. The answer is no, it is no longer a free and public forum thanks to our two friends last year and the response we felt was ecessary I censored posts thereby making it a non-public forum. I have the legal authority to limit free speech here, the FDA does not, so that's why they threaten me by not answering the question in order to prevent other's freedom of speech here.

Re: Response from FDA

Scott R on 3/16/02 at 16:24 (076594)

Maybe someone could call Erin and ask her if i'm responsible for their posts. :)

Re: Response from FDA

BrianJ on 3/16/02 at 17:58 (076598)

John H --

As an aside, I must say I pay particular attention to your comments because of your background as a military pilot. My dad flew Corsairs, B-25s, F9Fs, F-8 Crusaders and such in the Marines, and I know that pilots tend to be analytical and bottom-line oriented. Keep up the good work.

Re: Re:Is that what you wnat me to do

DR Zuckerman on 3/17/02 at 10:09 (076636)

IS that what you wnat me to do . I will if you want me too.

Re: Re:Is that what you wnat me to do

Scott R on 3/17/02 at 10:50 (076637)

Dr Z, I was talking about patients who don't have a financial connection to the big O. They would be the least subject to FDA regulations.

Re: Response from FDA

Allan G on 3/17/02 at 21:13 (076692)

Hi again
Your comments are pretty correct. I thank you for the consideration of my comments as they come with 3 years of ESWT experience.
Regards Allan G

Re: cost of treatment

Teresa M on 7/15/02 at 17:15 (089710)

Inquiring if the prices quoted of $1,500 in Canada for treatment and rooms are current or out dated and if outdated what current prices are for treatment?
Thank you.

Re: cost of treatment

Sunny Jacob - Bayshore on 7/16/02 at 06:09 (089749)

Teresa,
I assume you are referring to Bayshore ESWT clinics.
Bayshore's treatment cost (3 sessions done on alternate days) is $US 1,050.
Hotel room (Hilton) is $US 80/night; this is a special rate for Bayshore patients.
Please contact Cori Liuzzi at (email removed) for scheduling an appointment and other details.