FDA
20th October 2014

FDA Device Panel Recommends Against Approval of HIFU Treatment

On October 1st, the Gastroenterology and Urology Devices Panel of the FDA’s Medical Devices Advisory Committee voted against approval of a high-intensity focused ultrasound (HIFU).

FDA Device Panel Recommends Against Approval of HIFU Treatment

On October 1st, the Gastroenterology and Urology Devices Panel of the FDA’s Medical Devices Advisory Committee voted against approval of a high-intensity focused ultrasound (HIFU) device to treat some patients with recurrent prostate cancer created by SonaCare Medical Devices of Charlotte, North Carolina.

SonaCare Medical Devices’ Sonablate 450 is a computer-controlled device with a probe that clinicians can use to deliver HIFU energy through thermal ablation to the prostate. The proposed indication was for treatment of biopsy-proven recurrent cancer in patients, low to high risk, who have failed primary external beam radiation therapy and have prostate-specific antigen (PSA) readings lower than 10 ng/mL. The materials from this meeting can be found HERE.

Panel members voted 7 to 3 (with 1 abstention) recommending that the treatment was safe if used as intended; 9 to 2 against recommending that the treatment was effective if used as intended; and 10 to 0 (with 1 abstention) against recommending that the benefits of this device outweighed the risks.

The review was based on the interim analysis of results from a non-randomized, single-group clinical trial involving the first 100 of a planned 200 patients. Patients had pretreatment PSA readings ranging from 0.4 to 14 (mean, 4.9). Of the first 100 patients enrolled at 16 sites, 78 completed 12 months of follow-up and had a biopsy, and 22 did not.

Adverse events included seven rectal fistulas in five patients (5% rate compared with an expected 3% rate), three of whom required medical management and two of whom required surgery. Urinary incontinence occurred 55 times in 44 patients after treatment with Sonablate 450.

The panel encouraged the device manufacturer to continue to conduct research but to come back when the ongoing pivotal trial at 20 sites in the United States and Canada is completed, not halfway through.

Several panel members suggested that this vote was not the last word on this device’s approval. Panel member Jason Connor, PhD, an adaptive trials expert based in Orlando, Florida, said, however, that his vote of no on the last two questions was “not a terminal no,” and he encouraged SonaCare to continue the trial and get to 200 patients.

Susie Q. Lew, MD, from the George Washington University, Washington, DC, added, “I think there’s a niche for this device. I think we have insufficient data at this point.”

Interestingly, back in July, the panel voted against recommending another HIFU treatment.

The FDA is not bound by the recommendations of its advisory committee’s; however, it does take them into consideration.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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