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safety and efficacy

Posted by JohnW on 11/19/99 at 00:00 (012899)

Scott, I estimate that about 10,000 patients have been treated for pf on the ossatron, the vast majority in europe. In North America,less than 500 have been treated. On other machines there have probably been another 40,000 treatments but you must assume the average patient is treated 3 times on the competitive devices.

At the World congress earlier this year safety was discussed and it was confirmed that of the estimated 100,000 plus patients treated for all indications there were no reported incidents of patient injury.

There was one case reported in an achilles tendonitis case where the achilles ruptured several weeks after treatment. This is also not uncommon for surgical patients or those patients who go untreated. The patient was also participating actively in competitive sports at the time of the rupture.

By the way the next world congress is in Naples, Italy in June. There is a link at our web site.

Finally, perhaps you could contact the past president of the international societ, Dr. Wolfgang Schaden, Vienna @ med.eswt.schaden@aon.at. He would know of any reported incidents since the last meeting since this is one of the primary goals of the society.

Anecdotally, there was one reported cas in the us study where a patient complained of severe leg pain. The blind was broken and it was found that she had not been treated. It turned out she had a disk problem in the lower back that was constricing a nerve. You have my email if you have any other questions.