INDIANAPOLIS, Aug. 9 (UPI) -- U.S. firm Focus Surgery said Wednesday it has been given the go-ahead to test its medical device Sonablate 500 for prostate cancer.
The device uses high-intensity focused ultrasound for the treatment of low-risk, localized prostate cancer.
The study will enroll about 466 patients at 24 sites, the company said.
"We are excited by the news from the (Food and Drug Administration) and by the continued progress of the Sonablate 500 as demonstrated by our successful completion of the FDA approved pilot study," said Focus Surgery President and Chief Executive Officer Narendra Sanghvi.
"The HIFU technology utilized by the Sonablate 500 was developed in collaboration with the Indiana University School of Medicine, which is one of the planned study sites," he said.
Focus Surgery said its new system works by directing sound waves to quickly heat and kill diseased tissue while sparing the surrounding healthy tissue. The procedure is done on an outpatient basis and has been shown to cause fewer side effects related to prostate cancer, such as impotence and incontinence.
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