The U.S. Food and Drug Administration has granted 510(k) clearance to Ablatherm Integrated Imaging High-Intensity Focused Ultrasound (HIFU) for the ablation of prostate tissue. Focused ultrasound enables treatment of organ-confined prostate disease while preserving surrounding healthy tissue, and does not require radiation or surgery.
Ablatherm-HIFU has received FDA clearance less than one month following clearance of the first HIFU device for prostate tissue ablation, Sonablate (OT 11/25 issue).
Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who did not respond to radiotherapy treatment, according to EDAP TMS SA, the marketer of the treatment.
Clearance of Ablatherm HIFU is based on three clinical trials demonstrating a high overall rate of cancer-specific survival and a high rate of freedom from salvage therapy requirements for patients treated with the device for primary localized prostate cancer.
Ablatherm-HIFU has also previously been approved for commercial distribution in Europe and some other countries including Mexico and Canada.