FDA approves HIFU for “prostate tissue ablation”


According to a media release issued by SonaCare Medical early this morning, the company has received approval from the U.S. Food and Drug Administration (FDA) to market its Sonablate® 450 technology in the U.S.A. for prostate tissue ablation.

This approval of SonaCare’s technology, based on high-intensity focused ultrasound (HIFU), is unusual in a number of ways, and we look forward to seeing documentation of the reasons behind the FDA’s decision:

  • The approval is for an older form of the company’s technology and not for the newer Sonablate 500 technology, currently being used in Europe and elsewhere.
  • The approval is for an extremely broad indication — although there are almost no good, publicly accessible data from well-structured studies indicating the effectiveness and safety of the technology.
  • Last year, an FDA advisory committee recommended against approval of this technology in the very limited indication of treatment of men with radiorecurrent prostate cancer.

We should be clear that the standards for approval of medical devices have historically been very different to those for drugs and biological agents. One of the reasons for this is that so much about the therapeutic effectiveness and safety medical devices is dependent on how they are used by individual clinicians as opposed to the inherent qualities of the product itself.

It will be interesting to see whether, with this approval, SonaCare Medical and some of the leading experts in the use of HIFU in the treatment of prostate cancer now feel able to release and publish at least some of the long-term data that we assume they must have accurmulated.

We know that there is a significant learning cure associated with the therapeutic use of HIFU in the treatment of prostate cancer. We would strongly suggest to any patient that, if they wish to consider HIFU as treatment for prostate cancer, they seek out one of the very few highly experienced specialists who have, by now, probably treated at least 200 patients in this manner by operating on those patients in Mexico, the Caribbean, or elsewhere. It takes time to learn to do this well, and we still have no long-term data on the effectiveness and safety of HIFU from any of these experts.

Based on the currently available data (largely from Europe), with respect to its use in the treatment of prostate cancer, it appears the HIFU has significant potential utility in the management of

  • Patients with low- and very l0w-risk prostate cancer who are unable to accept long-term management on active surveillance (on account of anxiety or their projected life expectancy)
  • Patients with organ-confined, intermediate-risk prostate cancer
  • Carefully selected patients with (less aggressive forms of?) radiorecurrent prostate cancer

The “New” Prostate Cancer InfoLink would continue to note that side effects associated with HIFU are more common than some of its ardent advocates seem to appreciate — particularly when the technology is used by less experienced clinicians. Such side effects can include urinary retention, erectile dysfunction, and others, but serious long-term side effects appear to be relatively rare in well-managed patients. Readers who are interested can review detailed data published by the UK team which is one of very few groups to report and publish such detailed side effect data.

9 Responses

  1. Mike hit the proverbial nail on the head. Whichever treatment prostate cancer patients choose, from HIFU to surgery, it is incumbent to choose the most competent physician available to reduce the chances of side effects.

    Unfortunately, that has not been the case for da Vinci robotic surgery, where the learning curve is incredibly steep and yet novice physicians who are short on experience continue “pilot error’ at times, with documented catastrophic results to males in the US. You can find evidence on the prostate cancer blogs by unhappy men. Unfortunately, robotic surgery for prostate cancer was not vetted in the US by the FDA in the same way HIFU was for the past decade.

  2. Jim and others:

    Let me be very clear that the U.S. Food and Drug Administration (FDA) has no responsibility whatsoever for “vetting” the actual use of technology (made by da Vinci, by SonoCare Medical, or by anyone else). The FDA’s responsibilities are limited to the inherent risks and benefits of the technology itself. Where there is true equipment malfunction, the FDA wants to know. When there is operator malfunction, that’s not something they have responsibility for — and I would remind you of the old saw that “It’s a poor workman who blames his tools”.

    It is the responsibility of individual physicians, the institutions and medical groups they work for, and the management of those institutions and groups to ensure that physicians using medical technology (whether sophisticated or simple) are able to do so with a high degree of safety and efficacy. This is not the responsibility of the FDA.

    With respect to the problems with da Vinci surgery, the vast majority of the documented problems appear to have been associated with its use by insufficiently skilled and experienced physicians. These same physicians are quite likely to have been the same ones who weren’t very good at (or wouldn’t have been very good at) doing open prostatectomies either, before or after the availability of the da Vinci technology. The number of documented cases of true problems with the equipment itself — although not negligible — appears to have been very small considering the massive uptake of the technology over a very short time period.

    The degree to which any device manufacturer is even allowed to place controls over who can use their equipment is very limited once that equipment has been acquired by a hospital or medical practice group. And we know from data already available that, for almost every form of invasive treatment of prostate cancer, “the best” clinicians are the ones who will tell you to your face that they are still trying to learn to do specific procedures better … even after they have done thousands. Think of it this way: General Motors is responsible for the quality of the automobile it sells you, but you are responsible for how well (or badly) you drive it … and only the insurance companies are making any serious attempt to monitor how well most of us actually drive our cars (because it costs them money when we screw up).

    The best advice to patients regarding the selection of any technology when it comes to prostate cancer treatment is: “Don’t just pick the technology. You also need to pick the person who you want to have treat you with this technology, based on his or her skill and experience.” Unless there is a truly documentable equipment malfunction, complaining about the technology and/or the doctor and/or the FDA after the event, once you have made your decision about what you want to do, is rarely going to solve anything. The important thing is to do your homework really well in advance, and then accept that you are going to have to live with the consequences. Sometime the true “problem” can be the unusual, individual anatomy and physiology of the individual patient.

  3. Mike,

    You have such a gift for edifying all of us on the challenges prostate cancer patients face. Thanks for this.

    But to your point that, “It is the responsibility of the individual physicians, the institutions and medical groups they work for, and the management of those institutions and groups to ensure that physicians using medical technology (whether sophisticated or simple) are able to do with a high degree of safety and efficacy.”

    Therein lies the problem. Unless physicians work in a tightly controlled medical environment like Kaiser, there is virtually no binding oversight on physicians in the US. Many refuse to publish their personal success/failure results and hide behind the glass ceiling of poor communication/professional arrogance while they continue to their practice. Unfortunate to say the least.

  4. Is it correct that the FDA did not use an advisory committee to review the application? If so, in view of the disappointing history with HIFU, I’m wondering what their thinking was.

  5. Dear Elucidated1: I don’t write the rules. That one’s between you, your Congressman, the American Medical Association, and the physician state licensing boards.

    Dear Jim Waldenfels: There is no requirement on the FDA to hold advisory committee meetings about anything. As indicated above, I await the formal FDA documentation on approval to see if it will offer any insight.

  6. I am surprised at FDA approval of the older Sonablate 450 version rather than the newer Sonablate 500, now apparently primarily being employed in overseas locations. As noted, the problem for patients who may be encouraged to HIFU is determining the experience/expertise of the physician who will be administering the procedure. We really don’t have data on the outcome of HIFU treatment by those U.S. physicians who have encouraged patients to travel outside the U.S. to Mexico, out-islands, and elsewhere, wherein these physicians have administered HIFU at likely hefty income. A next road to cross is Medicare as well as other health insurers approving coverage. I would expect some health insurers will hedge on coverage by calling the procedure “still experimental” as, for example, BC/BS has done in several locations regarding coverage for CyberKnife radiation.

  7. Mr. Maack:

    The Sonablate 450 is in name only. Dr. Stephen Scionti, who has done more than 1,000 HIFU treatments, just sent me this:

    “The machine that we will use in USA is most advanced technology platform with integrated MRI fusion capability ….”

    Dr. Scionti will have one of the first HIFU devices in the US and will begin treating in December.

  8. Hurray! I had HIFU over 5 years ago and wish it had been legal in the USA and covered by insurance. After analyzing all the choices, the risk is on me, and I should be allowed to choose the treatment that makes sense to me. I know we need to be careful but this was long overdue.

  9. For the most recent update to the approval of Sonablate 450 for “ablation of prostate tissue” and the implications of the form of that regulatory approval, please click here.

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