FDA Advisory Panel Set to Review Ablatherm HIFU System for Prostate Cancer

Posted by The Evidence Blog on July 15, 2014

High intensity focused ultrasound (HIFU) for the treatment of localized prostate cancer has been commercially available outside the U.S. for almost 15 years. Two HIFU system brands have CE Marking for prostate cancer: Ablatherm (EDAP TMS) and Sonablate (SonaCare Medical).

No HIFU system is FDA approved to treat prostate cancer but a premarket approval application (PMA) for the Ablatherm Integrated Imaging device is now under Food and Drug Administration (FDA) review. On July 30, 2014, the FDA’s Gastroenterology and Urology Devices Advisory Panel will meet to examine the Ablatherm PMA and make nonbinding recommendations. The U.S. pivotal trial (NCT00295802) of Ablatherm for prostate cancer is unpublished to date. Ablatherm is proposed for use in the U.S.as a primary treatment for localized prostate cancer at low risk for recurrence.

There is no consensus about optimal management of localized prostate cancer. Current care treatment options range from active surveillance (watchful waiting) to radical prostatectomy. Factors considered when selecting a treatment include the risk of prostate cancer recurrence or metastasis, the patient’s overall health status, the patient’s age/life expectancy, and the patient’s informed preference.

The Sonablate HIFU device for prostate cancer is also advancing in the U.S. regulatory process. The phase III STAR trial (NCT00772317) of Sonablate 450 is ongoing at multiple U.S. centers. According to a manufacturer press release, an FDA advisory panel is tentatively scheduled to meet on October 2, 2014, to review a Sonablate 450 PMA, which seeks approval to treat locally recurrent prostate cancer in patients previously treated with external beam radiation.

  • Food and Drug Administration (FDA). July 30-31, 2014: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement. June 6, 2014. Available at: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm400702.htm. Accessed July 14, 2014.
  • USHIFU LLC. A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial). National Library of Medicine (NLM) Identifier: NCT00772317. ClinicalTrials.gov [online database]. Updated February 7, 2014. Available at: http://clinicaltrials.gov/show/NCT00772317. Accessed July 14, 2014.

Topics: Hayes Blog

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