FDA approves EDAP TMS’s Ablatherm technology for HIFU therapy

As predicted, the U.S. Food and Drug Administration apparently approved the Ablatherm brand of equipment for high-intensity focused ultrasound (HIFU) on November 9 for “the ablation of prostate tissue.” This is exactly the same indication as that issued to SonaCare Medical for that company’s Sonablate technology in mid-October.

For the detailed media release issued by EDAP TMS, please click here. There appears to have been very limited media coverage of the original announcement last month. Today, however, a very strange report on the HIT Consultant web site states that this approval is

paving the way for Ablatherm HIFU to become the treatment of choice for localized prostate cancer in the U.S.

Frankly, that is very highly unlikely. There are now way too many options available for the management of localized prostate cancer for any one method to become the “treatment of choice” for all forms of localized prostate cancer any more. Even opinion leaders in the US-based HIFU treatment community have clearly acknowledged that application of HIFU should be limited to a highly defined subgroup of men with prostate cancer at this stage.

What we can be quite sure of is that there is going to be an intense war between SonaCare Medical and EDAP-TMS for whatever share they can obtain of the prostate cancer HIFU treatment opportunity here in the USA. Patients need to be extremely cautious about some of the advertising they may be subjected to by hospitals and medical groups over the next 3 to 5 years. THis advertising is likely to include all sorts of utterly outrageous claims that can definitely not be made by the HIFY equipment manufacturers themselves.

2 Responses

  1. This technology was not approved to treat prostate cancer. The manufacturers and researchers had come to realize that would never occur. So they stepped back and asked for approval for “ablation of prostate tissue”. In other words to treat prostate hyperplasia, I presume. The use for prostate cancer would be off label and, without supporting evidence, any doctor who contends that this is a solid choice for prostate cancer needs to explain to his patient, as well as himself, what basis he uses for such a recommendation. Then the patient should seek another opinion and stay away from the first doctor.

  2. Dear Tarhoosier:

    Actually its not quite as clear as even that. The FDA’s approval was based on a new category of approval for medical devices. Dr. Scionti explained the details on this conference call. HIFU, as a consequence, is not categorically approved to treat any specific disorder. It is approved, however, for the ablation of any type of prostate tissue (healthy or unhealthy or cancerous). The real question is going to be whether payers will cover the use of this form of therapy in any type of prostatic disorder outside of clinical trials or some form of registry system.

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