FDA schedules meetings to review PMAs for Ablatherm’s, SonoCare’s HIFU devices


According to a media release issued earlier today by EDAP TMS, the U.S. Food and Drug Administration (FDA) has scheduled a meeting on July 30, 2014, to review the Pre-Market Approval (PMA) application for EDAP’s Ablatherm-HIFU device for the treatment of localized prostate cancer. The meeting will be of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee of the FDA.

On May 8, SonoCare Medical had issued a media release stating that the same committee would meet on October 2, 2014, to review a comparable PMA application for the company’s Sonablate 450 HIFU technology.

It should be noted that in the case of both companies, the technology that is being reviewed by the FDA has now been outdated in clinical use outside the USA by updated versions of the proprietary technology. In the case of SonoCare Medical, the company is now marketing the Sonablate 500 system in Europe. In the case of EDAP TMS, the company is already marketing the its Focal One® technology for the dedicated focal therapy of prostate cancer.

8 Responses

  1. Isn’t it interesting that local laser ablation is now being done in multiple places in the US, out of pocket, yet has never been FDA approved for prostate cancer?

  2. Not really. FLA has been approved for other things. It is being used off-label.

  3. I am unaware of any HIFU series with results at around 5 years that are even near to comparable to results for surgery and radiation. Have there been any encouraging results, especially for men who are not good candidates for active surveillance (in other words, intermediate- or high-risk patients)?

  4. Isn’t it interesting that treatments are used “off label?” Wasn’t FLA originally used for brain tumors?

  5. Jim:

    I am not aware of any such data. We shall have to see what the companies bring to the table at the advisory committee meetings.

  6. OFFICIAL NOTICE OF FDA HEARING ON HIFU DEVICES

    I’ve been periodically watching for the official details, and they have now been posted on the FDA’s web site.

    Sitemaster — thanks for your comment.

  7. Jim:

    If you read the FDA’s announcement with care, you will note that the only indication being sought by Ablatherm is for the treatment of men with low-risk prostate cancer — large numbers of whom (presumably) do not actually need treatment at all because they could just be monitored.

  8. “treatment for of men with low-risk prostate cancer?” You mean the same diagnosis for tens of thousands of US men who are told their choices are radiation or surgery?

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