Sonorex / SonocurPosted by J. P. (Sunny) Jacob on 11/18/04 at 21:39 (164311)
You have, probably unintentionally, quoted several times ‘Sonorex' being an equipment, which may confuse some patients. Just to clarify, ‘Sonorex' is the name of a clinic operator/distributor for Sonocur equipment manufactured by Siemens, Germany.
Re: Sonorex / SonocurEd Davis, DPM on 11/19/04 at 10:42 (164344)
I stand corrected. Siemens is the manufacturer. They make the Sonocur Basic and and Sonocur Plus (unsure if that is still in production). The Sonocur Plus is the basic plus ultrasound. Sonorex is a North American distribution company/network that has clinics in Canada and private office Sonocur placements in the US.
Re: Sonorex / Sonocurjohn on 11/20/04 at 08:42 (164404)
The Sonocur Basic is the only model that is FDA approved. Do you find it strange that Siemens did not try to get FDA approval for their Sonocur Plus given the importance of ultrasound imaging? I believe that Sunny uses the Sonocur Plus. Why did they choose to get approval for their 'Basic' model?
Re: Sonorex / SonocurEd Davis, DPM on 11/20/04 at 12:38 (164425)
There are diffences of opinion over the importance of ultrasound imaging.
Re: Sonocur Basic / Sonocur PlusJ. P. (Sunny) Jacob on 11/20/04 at 13:35 (164434)
In response to your question why Sonocur Plus (the model with in-line ultrasound imaging) is not approved by FDA:
This answer is based on my recollection going back to 5 or 6 years ago. The ultrasound used with the system is a 5 / 6 / 7.5 MHz micro-sector applicator integrated with the shockwave head by a sophisticated Adora software system. Sonocur Basic with the addition of the ultrasound makes the Sonocur Plus.
For FDA approval in the US, the ultrasound part is considered a diagnostic tool which caused additional road blocks for an ESWT approval. FDA may also have insisted that the provider should be ultrasound-certified (although the primary use of ultrasound in Sonocur Plus is for accurate targeting of the shockwave, - not for diagnosis). Of course, trained clinical staff can use the ultrasound also to measure, for example, fascia thickness or disintegration rate of calcification.
From a marketing point of view, the presence of ultrasound would have been a disadvantage because it would have restricted the use of Sonocur Plus to radiologists. In addition, Sonocur Plus would have been approx. $70,000 more expensive than Sonocur Basic.
In Europe, almost all users of Sonocur Plus are Orthopedic surgeons and ultrasound is a regular part of medical training. In the case of independent clinics in Europe, or like us in Canada, the Medical Director is responsible and capable of assuming this task.
In Europe, the imaging component also prevented paramedical professionals to do ESWT. In our clinic, Sonocur Plus is absolutely necessary for both, orthopedic and urological use.
Re: Sonocur Basic / Sonocur PlusEd Davis, DPM on 11/20/04 at 16:27 (164443)
Interestingly, if Sonocur works then Sonocur Plus must work, FDA approval or not. As far as I know they do the same thing therapeutically except that Sonocur Plus adds ultrasound imaging. Again, this is some of the silliness inhererent in the approval process. I, as a podiatrist, routinely use diagnostic ultrasouund in the office so have the Plus available would be potentially beneficial, particularly when the time comes that we start treating multiple tendinopathies, for example FHL tendinpathy would do better if imaging and a very small head is available... PS, I checked the Siemen's web site but could not find the Sonocur Plus. Do you know if they are still making it?
Re: Sonorex / Sonocurjohn on 11/20/04 at 20:13 (164459)
Putting differences aside, Sunny and the rest of Europe obviously believe in ultrasound. Dornier believed in ultrasound. It seems like Siemens should have sought approval for the Sonocur Plus in order to give the option of using ultrasound.
Sunny's assertion that the FDA might have insisted that the provider be ultrasound certified is simply wrong. The FDA allows podiatists and physicians to perform ultrasound. There is no requirement for ultrasound certification for the Dornier machine and the Dornier machine was approved before the Siemens. Furthermore, ultrasound systems do not add $70,000 to the cost of the machine. An ultrasound system could be added for no more than $19,000.
Re: Sonocur Basic / Sonocur Plusjohn on 11/20/04 at 20:16 (164460)
Isn't it silly that Siemens did not try to get the Sonocur Plus approved since it was the preferred machine in Canada and Europe? Why would they discontinue such a successful product?
Re: Sonocur Basic / Sonocur PlusDr. Z on 11/20/04 at 23:04 (164463)
John, Dr. Ed
I wonder if you can get ultrasound added to the sonocur for additional money.
Re: Sonocur Basic / Sonocur PlusJ. P. (Sunny) Jacob on 11/21/04 at 11:24 (164482)
Of course, the equipment can do the job whether or not ultrasound imaging is available for PF. I was trying to explain the reason why Siemens did not go for FDA approval for Sonocur Plus and why Europe continues to use Sonocur Plus. We use inline ultrasound as it provides accurate targeting and more confidence for the therapist.
Moreover, the ultrasound image printout, before and after treatment, also helps. It is necessary for tendonitis treatment and indispensable for Peyronie's disease.
Re: Sonocur Basic / Sonocur PlusEd Davis,DPM on 11/21/04 at 20:38 (164512)
It would not seem likely if the ultrasound is in line but not technically impossible.
Re: Sonorex / SonocurScott R - moderator on 11/22/04 at 16:01 (164553)
John, if you make statements that could be considered libel, you have to disclose who you are.
Re: Sonorex / Sonocurjohn on 11/22/04 at 17:15 (164556)
What statements have I made that are false and could be considered libel? If I have made any false statements that caused harm then I appologize, I have never intended to make false statements.
Again, please point out the false statements, I'll gladly review them and give an explanation or retraction.
Re: Sonorex / SonocurEd Davis, DPM on 11/23/04 at 18:58 (164630)
You, again, are making some generalizations when you state 'the rest of Europe obviously beleive in ultrasound.' I would look at the ismst.com webiste to compare machines as that is simply not true. Additionally, Ossatron does not use ultrasound in the US.
I think that the target size will determine, to an extent, the utility of ultrasound. The plantar fascia is a huge target and hard to miss. Other areas can be trickier.
Re: Sonorex / Sonocurjohn on 11/23/04 at 23:10 (164650)
I'm sorry. I should have qualified the statement. I understood from Sunny that the Sonocur Plus was prefered over the Sonocur among Orthopedic surgeons in Europe and that the Sonocur Plus uses ultrasound. Sunny said that he uses the Sonocur Plus. It seemed to me that ultrasound provided a benefit.
As we both know, the Dornier Epos Ultra is the only FDA approved machine that uses ultrasound. The Healthtronics Ossatron and Siemens Sonocur do not use ultrasound.
I can't comment medically on the utility of ultrasound but take my clues from others who are using ultrasound guided ESWT.