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FDA Approves First Focused Ultrasound System for Prostate

Tuesday, October 13, 2015  
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The US Food and Drug Administration has approved SonaCare Medical’s Sonablate 450 focused ultrasound system for the ablation of prostate tissue. Focused ultrasound enables treatment of organ-confined prostate disease while preserving surrounding healthy tissue, without radiation or surgery.

“For men with conditions like prostate cancer, the option of a non-invasive procedure that can selectively target and treat diseased tissue is very appealing,” says Neal Kassell, MD, Chairman of the Focused Ultrasound Foundation. “American men have been traveling overseas for focused ultrasound treatment for prostate diseases for years, and we are pleased that they will now have access to this innovative treatment at leading centers in the United States.”

More than 50,000 men around the world have been treated with focused ultrasound for prostate cancer. It is the leading clinical application of the technology -- more than 50% of the patients who have undergone focused ultrasound around the globe have had prostate disease treated.

The technology has been successfully used to treat a wide variety of diagnoses, including benign prostatic hyperplasia (BPH), partial gland cancer, localized whole-gland prostate cancer, and recurrent prostate cancer.

“I believe that we are at a pivotal point in prostate care,” said Michael Koch, MD, Sonablate trial investigator and Chairman of the Department of Urology at Indiana University. “Simultaneous advances in imaging, fusion technologies, and now more focused therapies are going to allow us to precisely diagnose prostate conditions and ablate these targeted areas rather than perform whole gland prostate surgery, which carries a significant burden on quality of life. Focused ultrasound will become the work-horse of subtotal prostate therapy.”

In addition to Sonablate, EDAP’s Ablatherm focused ultrasound system for treating the prostate is under FDA review and may be approved soon. Focused ultrasound devices have been cleared to treat the prostate in more than 40 countries since the first approval in 2000. Several systems for focused ultrasound ablation of prostate tissue are commercially available or being researched in other geographic regions with differing guidance methods (ultrasound vs. magnetic resonance imaging) and approach (transrectal or transurethral).

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