|EDAP's Ablatherm system--Courtesy of EDAP TMS SA|
The FDA's Gastroenterology & Urology Devices panel came down firmly against EDAP's Ablatherm system for treating low-risk, localized prostate cancer. The panel voted 9-0 on the device's effectiveness, 5-3 against its safety (with one abstention) and said the risks outweigh the benefits by a vote of 8-0 (with one abstention).
The vote is not binding but certainly lowers the chances that the FDA will approve the product's PMA application.
The CE marked Ablatherm system is intended to treat prostate cancer by ablating the entire prostate gland via high intensity focused ultrasound (HIFU), which generates heat of around 200 degrees Fahrenheit, according to the FDA's meeting literature. There are no other HIFU devices on the market. Most men with the condition are treated with radical prostatectomy surgery, radiation or regular monitoring with delayed surgery if needed, according to the FDA.
"We are disappointed by the Committee's recommendation regarding Ablatherm-HIFU for the treatment of low-risk, localized prostate cancer and we appreciate the dialog during today's meeting. We look forward to subsequent discussion with the FDA. We will continue to work diligently with the FDA as it carefully completes its final review for Ablatherm-HIFU's PMA," said EDAP CEO Marc Oczachowski in a statement.
The panel said that the primary endpoint assessing the device's noninferiority to cryotherapy at two years was inadequate because the timeframe was too short, noting that it can take 20 years for prostate cancer to become fatal, according to Mass Device. They also pointed to the frequency of adverse events including erectile dysfunction urinary incontinence, and urethral and bowel injury, according to the article.