FDA gives 510(k) approval to Ablatherm Integrated Imaging HIFU for prostate cancer- EDAP TMS

EDAP TMS has received 510(k) clearance from the FDA to market Ablatherm Integrated Imaging HIFU in the USA for the ablation of prostate tissue. HIFU (high intensity focused ultrasound) treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localised prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.

A previous filing with the FDA was rejected in 2014 when the FDA's Gastroenterology & Urology Devices panel voted against EDAP's Ablatherm system for treating low-risk, localised prostate cancer. The panel voted 9-0 against 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 FDA 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. They also pointed to the high frequency of adverse events including erectile dysfunction, urinary incontinence and local morbidity.

Comment: The recent FDA approval of the Sonablate 450 HIFU device in prostate cancer allowed EDAP TMS to withdraw its de novo application rejected in 2014 and instead pursue approval via the 510(k) route, which only requires demonstration of the equivalence of the new device compared to one which has already been approved.