EDAP TMS submits data for approval of HIFU to US FDA

We understand from media reports that the French medical device company EDAP TMS has submitted documentation to the U.S. Food & Drug Administration (FDA) for pre-market approval of their Ablatherm technology for treatment of low-risk, localized prostate cancer with high-intensity, focused ultrasound (HIFU).

Apparently EDAP TMS has stated (see this newsfeed on the MedicalPhysicsWeb site) that their submission is backed by data from the company’s Phase II/III U.S.-based ENLIGHT study. As of this morning, however, there is no media release on the EDAP TMS corporate web site.

The ENLIGHT trial supposedly enrolled more than 400 patients with localized disease between 2006 and 2010 and that these patients were followed through July 2012. In August 2012, EDAP TMS issued a media release stating that the company had completed the trial follow-up and data collection phase.

To date, The “New” Prostate Cancer InfoLink has seen no data reporting the results of this U.S. trial. Data from a European trial that enrolled patients at six European sites between 1995 and 1999 were reported by Thüroff et al. as long ago as 2003.

We should also note that if EDAP TMS is successful in gaining approval to market the Ablatherm technology for treatment of localized prostate cancer, it is possible that their competitor (HIFU International) will bne able to gain approval for the competing Sonablate techology through a so-called 501(k) application, without the need to conduct any further clinical trials.

At present, no form of treatment using HIFU has been approved in the United States for the treatment of any stage or grade of prostate cancer. There is no clear data about how long it may take the FDA to review the data submission referred to above.

6 Responses

  1. My impression is that HIFU trials have not shown good results.

    Am I wrong?


  2. Dear Doug:

    I think that depends on one’s perspective, but what I think I can say with a degree of honesty is that the published data currently available has not offered compelling evidence that HIFU is either more effective or (necessarily) significantly safer than other forms of treatment.

    Having said that, there are few published data from trials of the Sonablate technology, so it is hard to tell just how good or safe this technology really may be.

  3. Why should they get approval for a study that shows nothing about long-term survival when they treated mostly men who did not need anything at all. No wonder medical costs are out of whack!

  4. Well … Maybe they won’t!

  5. I don’t think there has been enough time to make sound conclusions from long-term studies. Better conclusions may come out in the future. Prostate cancer is more serious than prostate hypertrophy. Has HIFU been used to treat BPH? Are there any studies ongoing with BPH and HIFU?

  6. Dear Sal:

    I suppose that, in theory, HIFU could be used to treat BPH under certain circumstances … but there are many better ways to treat BPH, so I am not sure why anyone would want to do this, and I am not aware of any trials that are investigating this either.

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