Non Invasive Prostate Cancer Treatment with Sonablate(R) 500 Approved in Canada

Treatment of Prostate Cancer

CHARLOTTE, N.C., June 15 /CNW/ -- On June 1, 2005 Health Canada granted U.S. HIFU, of Charlotte, NC, Class III Medical Device approval for the use of the Sonablate(R) 500 in Canada for the treatment of prostate disease with High Intensity Focused Ultrasound (HIFU).

The Sonablate(R) 500, developed and manufactured by Focus Surgery Inc., of Indianapolis, IN, is a non invasive medical device that uses HIFU to destroy tissue within the prostate without affecting surrounding tissue. In the past two-and-a-half years, nearly 3,500 total patients with prostate disease have been treated with the Sonablate(R) 500.

Dr. George Suarez, U.S. HIFU Medical Director said, "We are very excited about developing a solid relationship with Canadian urologists. This should be an easy transition since many doctors have already begun the training process."

In approved countries, HIFU with the Sonablate(R) 500 has been successful as both a primary treatment for prostate disease and as a salvage treatment when radiation or surgery has failed.

The out-patient procedure is performed under epidural or spinal anesthesia using a transrectal ultrasound probe. The one-time treatment lasts two to three hours and can be applied repeatedly if needed. HIFU with the Sonablate(R) 500 does not require any additional surgeries, such as a transurethral resection of the prostate (TURP), making it an entirely non invasive HIFU device.

The Sonablate(R) 500 is treating patients in Europe, including the United Kingdom, as well as parts of China, Japan, Mexico, Russia and the Dominican Republic. Five-year results from a Japanese study by Dr. Toyoaki Uchida reported an 88 percent clinical success rate at one year. Additionally, a multi-center study by Suarez reports that 80 percent of patients had a prostate specific antigen (PSA) of less than one after one year with no incidence of urinary incontinence and minimal reports of erectile dysfunction.

U.S. HIFU Vice President of Clinical Operations, Alex Gonzalez said, "Approval of this technology allows Canadian men access to the most cutting edge technology for the treatment of prostate cancer. They will no longer have to travel to other countries to receive this revolutionary treatment for prostate cancer."

According to the Prostate Cancer Research Foundation of Canada, at least one in every seven Canadian men is expected to develop the disease in their lifetime; approximately 20,500 Canadian men are diagnosed each year.

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Web site: http://www.ushifu.com