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SONOCUR IS AN FDA APPROVED DEVICE

Posted by Ed Davis, DPM on 10/31/02 at 20:28 (098848)

See my mesage below of 10/31/02 @ 20:22.
Ed

Re: SONOCUR IS AN FDA APPROVED DEVICE

ortho-pod on 11/02/02 at 15:25 (099059)

but not for heel pain where is your data and studies????

Re: SONOCUR IS AN FDA APPROVED DEVICE

Ed Davis, DPM on 11/02/02 at 15:37 (099063)

There are numerous studies conducted in Europe, not to mention almost 10 years of experience of practioners in Europe with this modality.

If you are a health care professional you certainly know how to get the information/studies.
Ed

Re: your real name?

Ed Davis, DPM on 11/02/02 at 15:40 (099064)

By the way -- how about telling us who you are?
Ed

Re: SONOCUR IS AN FDA APPROVED DEVICE

Bill on 11/02/02 at 19:29 (099096)

Ed,

This is interesting. Someone else feels strongly about the fact that the Sonocur is not FDA approved for PF. It's not just me. I didn't sent the other message.

Re: SONOCUR IS AN FDA APPROVED DEVICE

nancy s. on 11/02/02 at 19:36 (099098)

bill, we'll never know for sure, will we? because you won't identify yourself and your interest, and no doubt neither will this other anonymous opinion-giver. so maybe you are one and the same, and maybe you aren't.

at this point, i don't think it matters. i've been following the discussion, and the only perspectives i really respect and can give any credence to are those of people who are known and true contributors to this website.

nancy
.

Re: SONOCUR IS AN FDA APPROVED DEVICE

Ed Davis, DPM on 11/02/02 at 19:58 (099100)

It is a big country -- I am sure there are more people who share your point of view. Why do you seem surprised? This individual has assumed a pseudonym that implies that he is a health professional but will no reveal who he is.

Are you not a bit concerned that the FDA approval process here was heavily politicized by the incorrect classification?
Ed

Re: SONOCUR IS AN FDA APPROVED DEVICE

Bill on 11/03/02 at 08:17 (099139)

I don't know that the classification is incorrect.

The PMA study for the Ossatron had two serious adverse events. The reported 'Two subjects receiving ESWT sustained midsubstance plantar fascia tears during the course of the study.'

This event was serous enough that the FDA required further study.

Are you concerned about plantar fascia tears with the Ossatron?

I don't see any politics here. I see a desire to protect the public.

It took 16 years for renal lithotripters to move from Class 3 to Class 2 with special controls. New renal lithotripter designs either have to show that they are equivalent to previous marketed devices and get to enter under Class 2 with special controls or they are determined to be Class 3.

I think high energy machines are correctly classified.

Re: SONOCUR IS AN FDA APPROVED DEVICE

Dr. Z on 11/03/02 at 16:31 (099187)

There was also a patient that developed a hypertensive episode during the procedure but no long term complications. I though tha the pf tears were months down the road from ESWT treatment and therefore no correlation was assigned to the ESWT treatment from the ossatron.

Re: SONOCUR IS AN FDA APPROVED DEVICE

Ed Davis, DPM on 11/04/02 at 19:32 (099350)

I would need to doubt the relationship of the tears to the treatment. Nevertheless, such a problem has never been encountered with the low energy treatment. Placing high energy shock waves over a vital organ such as the kidney is much more serious and invasive than using low energy shock waves over a ligament or tendon -- just not in the same league by a mile.
Ed

Re: SONOCUR IS AN FDA APPROVED DEVICE

ortho-pod on 11/02/02 at 15:25 (099059)

but not for heel pain where is your data and studies????

Re: SONOCUR IS AN FDA APPROVED DEVICE

Ed Davis, DPM on 11/02/02 at 15:37 (099063)

There are numerous studies conducted in Europe, not to mention almost 10 years of experience of practioners in Europe with this modality.

If you are a health care professional you certainly know how to get the information/studies.
Ed

Re: your real name?

Ed Davis, DPM on 11/02/02 at 15:40 (099064)

By the way -- how about telling us who you are?
Ed

Re: SONOCUR IS AN FDA APPROVED DEVICE

Bill on 11/02/02 at 19:29 (099096)

Ed,

This is interesting. Someone else feels strongly about the fact that the Sonocur is not FDA approved for PF. It's not just me. I didn't sent the other message.

Re: SONOCUR IS AN FDA APPROVED DEVICE

nancy s. on 11/02/02 at 19:36 (099098)

bill, we'll never know for sure, will we? because you won't identify yourself and your interest, and no doubt neither will this other anonymous opinion-giver. so maybe you are one and the same, and maybe you aren't.

at this point, i don't think it matters. i've been following the discussion, and the only perspectives i really respect and can give any credence to are those of people who are known and true contributors to this website.

nancy
.

Re: SONOCUR IS AN FDA APPROVED DEVICE

Ed Davis, DPM on 11/02/02 at 19:58 (099100)

It is a big country -- I am sure there are more people who share your point of view. Why do you seem surprised? This individual has assumed a pseudonym that implies that he is a health professional but will no reveal who he is.

Are you not a bit concerned that the FDA approval process here was heavily politicized by the incorrect classification?
Ed

Re: SONOCUR IS AN FDA APPROVED DEVICE

Bill on 11/03/02 at 08:17 (099139)

I don't know that the classification is incorrect.

The PMA study for the Ossatron had two serious adverse events. The reported 'Two subjects receiving ESWT sustained midsubstance plantar fascia tears during the course of the study.'

This event was serous enough that the FDA required further study.

Are you concerned about plantar fascia tears with the Ossatron?

I don't see any politics here. I see a desire to protect the public.

It took 16 years for renal lithotripters to move from Class 3 to Class 2 with special controls. New renal lithotripter designs either have to show that they are equivalent to previous marketed devices and get to enter under Class 2 with special controls or they are determined to be Class 3.

I think high energy machines are correctly classified.

Re: SONOCUR IS AN FDA APPROVED DEVICE

Dr. Z on 11/03/02 at 16:31 (099187)

There was also a patient that developed a hypertensive episode during the procedure but no long term complications. I though tha the pf tears were months down the road from ESWT treatment and therefore no correlation was assigned to the ESWT treatment from the ossatron.

Re: SONOCUR IS AN FDA APPROVED DEVICE

Ed Davis, DPM on 11/04/02 at 19:32 (099350)

I would need to doubt the relationship of the tears to the treatment. Nevertheless, such a problem has never been encountered with the low energy treatment. Placing high energy shock waves over a vital organ such as the kidney is much more serious and invasive than using low energy shock waves over a ligament or tendon -- just not in the same league by a mile.
Ed