HIFU Ultrasound Approved by US FDA for Prostate Cancer Treatment

The US Food and Drug Administration (FDA) have fully approved High Intensity Focused Ultrasound Therapy (HIFU) therapy after more than 10 years of clinical trials for the treatment of localized prostate cancer.

The procedure is also approved by Health Canada, and consists of one treatment for men with stage T-1 or T-2 organ-confined prostate cancer. The HIFU therapy is used on patients who failed treatment with radiation therapy, and can be repeated if necessary. Prostate cancer is the main cancer affecting men in North America, according to the American Cancer Society, affecting 200,000 men in 2015, with more than 25,000 fatalities. HIFU treatments are already approved in Europe and more than 40,000 patients have been treated around the world.


Maple Leaf HIFU (Ancaster, ON, Canada) has the most experience in treating prostate cancer patients with Ablatherm HIFU integrated imaging device in North America. The device has a computer-controlled rectal probe that is used to target the tumor and destroy the prostate tissue using ultrasound waves, without damaging surrounding organs. The treatment option has minimal side effects.

Dr. William Orovan, lead urological surgeon, said, "Ablatherm HIFU has the best patient safety outcomes by far and cure rates are excellent. Side effects of HIFU, including incontinence and erectile dysfunction, are much less than traditional surgery or radiation."

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