EDAP TMS submits revised application for approval of their form of HIFU technology

As predicted in yesterday’s post about the nature of the approval of SonaCare Medical’s Sonablate technology as a “generic” form of treatment for prostate tissue ablation, we are likely to see rapid approval of the Ablatherm brand of HIFU technology here in America very soon as well.

Apparently, EDAP TMS, the manufacturer of the Ablatherm technology, has immediately withdrawn its earlier applications to the U.S Food and Drug Administration (FDA) for approval of Ablatherm and has, instead, submitted an application under the standard 510(k) pathway for approval of new medical devices that are similar in process to an approved device delivering a generic form of therapy. The text of EDAP TMS’s media release is available on line.

The “New” Prostate Cancer InfoLink would expect approval of the Ablatherm technology within about 6 months or perhaps less. The Ablatherm technology has been used in Europe since the late 1990s and is also approved for use in Canada. Although early results from use of the Ablatherm technology were less than entirely promising, there is no reason, today, to believe it is necessarily any worse (or better) in terms of the results it can deliver than the SonaCare Medical equipment. It seems much more likely that the quality of the patient outcome is determined by the skill of the clinician using the equipment.

There are no meaningful clinical data (that we are aware of) comparing the outcomes achievable with the two different types of equipment in the hands of experienced HIFU users. The “New” Prostate Cancer InfoLink has received one extraordinary, self-promotional message from one U.S.-based physician about the quality of the results he claims to have achieved using the Ablatherm technology. Since the results he claims are not (at least at this time) supported by peer-reviewed, published data, we decided it would be inappropriate to post such a message to this site. The continuing lack of detailed, published, peer-reviewed data from any extended series of patients treated by U.S.-based clinicians, when we know that some clinicians claim to have treated well over 400 patients (and maybe more than 1,000 in some cases), continues to be a major embarrassment.

2 Responses

  1. Why don’t we have any clinical data on this? HIFU sounds like an amazing idea, and with greater need should come greater demand. And saving people’s lives? What greater demand than that can there be?

  2. Dear Sandy:

    I wish I knew. Here are couple of links to the most detailed information that I am aware of on a large cohort of HIFU patients:

    Finally … Some real 5-year outcome data on HIFU, but were the right patients being treated?
    Outcomes after first-line and repeat HIFU procedures in the UK

    I am told that the people who are supposedly experts in carrying out HIFU get much better results that this. … If so, it is beyond me why they haven’t been published.

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