EDAP Receives FDA Approval for Ablatherm HIFU

On November 9, 2015 the Food and Drug Administration (FDA) granted full approval to EDAP Ablatherm HIFU to carry out prostate ablation treatment in the United States, using the Ablatherm Integrated Imaging device.

As the first North American provider of this technology and treatment for prostate cancer Maple Leaf HIFU is very pleased to see the FDA confirm the safety and efficacy of this HIFU modality in which we strongly believe.

Maple Leaf HIFU will continue to offer this treatment to Canadian and American patients from our Cleveland Clinic Canada facility in Toronto. In time new sites and new groups will provide service in the United States but Maple Leaf HIFU remains, by far, the most experienced North American provider and will continue to be so.

At present, in the United States there is not a CPT code for HIFU Ablation and it may be some time before insurers, public or private, will routinely reimburse patients for HIFU treatment. During this time Maple Leaf HIFU will, on a best efforts basis , continue to assist our patients with insurance issues through their insurance provider(s).

High Intensity Focused Ultrasound (HIFU)

Treatment of Organ-Confined Prostate Cancer.

Learn more about the High Intensity Focused Ultrasound prostate cancer treatment (pdf) from an article in the Urology and Kidney Disease News by the Glickman Urological and Kidney Institute Volume 20, Winter 2011 physician journal publication.

Read a review of the scientific foundation, technology and clinical outcomes with HIFU as a treatment for prostate cancer . (pdf) This article was written by Canadian Doctor, John C. Rewcastle, Ph.D. The article defines HIFU as a technically advanced, definitive local therapy for prostate cancer.

Research Articles

Read published articles on High Intensity Focused Ultrasound treatments for prostate cancer.

Clinical Information

Learn more about the clinical information of HIFU, histology, MRI, and PSA post-treatment.

Research Abstracts

For the physician, clinician or patient who wishes to view additional research, see our list of research abstracts on HIFU.

Clinical Studies

Read more about clinical studies and long term results published regarding the effectiveness and safety of Ablatherm HIFU.


View videos on HIFU including patient testimonials, the procedure, treatment and physician information.