Clinicians now have a new tool for combating prostate cancer in a non-invasive way. The U.S. Food and Drug Administration (FDA) on October, 9, 2015, approved a high intensity ultrasound system (Sonablate 450) for prostate tissue ablation.1

This approach allows for selectively targeting and treating diseased tissue while preserving healthy tissue. Ideally, it can eliminate the need for radiation or surgery.

The FDA ruled that this device is approved for transmitting high intensity therapeutic ultrasound (HITU) energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance.

In a letter to SonaCare Medical LLC, it stated that “this classification does not include devices that are intended for the treatment of any specific prostate disease.”1


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The letter also stated that this approval does not include other devices for ablating non-prostatic tissues/organs.

“It is a game changer for men, but patients have to be well selected,” said Stephen Scionti, MD, who runs the Scionti Prostate Cancer Center in Sarasota, FL.

Dr. Scionti, who participated in the clinical trials and has been involved with this for 10 years, said the procedure has been available overseas for several years with a proven track record of treating organ-confined prostate disease.

To date, HITU technology has been successfully used to treat a wide variety of diagnoses, including benign prostatic hyperplasia, partial gland cancer, localized whole-gland prostate cancer, and recurrent prostate cancer.

Neal Kassell, MD, who is chairman of the Focused Ultrasound Foundation in Charlottesville, VA, said American men have been traveling overseas for focused ultrasound treatment for prostate diseases for years and more than 50,000 men around the world have been treated with focused ultrasound for prostate cancer.

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Focused ultrasound devices have been cleared to treat the prostate in more than 40 countries since the first approval in 2000.2

Several systems for focused ultrasound ablation of prostate tissue are commercially available or are being researched in other geographic regions with differing guidance methods (ultrasound versus magnetic resonance imaging) and approach (transrectal or transurethral).