Men in America will no longer have to travel out of the country to receive focused ultrasound (FUS) treatment for their prostate. In October 2015 the Food and Drug Administration (FDA) approved – for the first time in the United States – a focused ultrasound system, SonaCare Medical’s Sonablate 450, for the ablation of prostate tissue. Three weeks later, the FDA approved EDAP’s Ablatherm Robotic HIFU for the ablation of prostate tissue. The US now joins approximately 50 countries around the world where FUS is commercially available for treating the prostate.
“[This decision] is a milestone for non-invasive prostate care and a tremendous gain for men’s health,” said Mark Carol, MD, Chief Executive Officer of SonaCare Medical. “There are numerous peer reviewed articles attesting to focused ultrasound’s value in ablating the prostate while minimizing the occurrence of side effects.”
Marc Oczachowski, EDAP Chief Executive Officer stated, “The pieces are in place for rapid deployment of Ablatherm devices in the US and we look forward to bringing the technology to urologists as well as patients in need.”
Both the Sonablate and Ablatherm systems are designed to destroy prostate tissue by delivering focused ultrasound energy through a transrectal probe. This enables the treatment of prostate tissue while minimizing damage to surrounding tissue, without radiation or surgery. More than 50,000 men around the world have been treated with high intensity focused ultrasound (known as FUS or HIFU) for prostate cancer which is the leading clinical application of the technology – in fact, more than 50% of all FUS procedures performed to date around the globe have been for prostatic diseases. The technology has been used to treat a wide variety of prostate-related diagnoses, including benign prostatic hyperplasia (BPH), partial gland cancer, localized whole-gland prostate cancer, and recurrent prostate cancer. Please note that the FDA has approved the use of HIFU for prostate ablation because the devices effectively destroy targeted prostate tissue with a reasonable safety profile. The treating physician determines how to best treat each patient with prostate disorders using all available treatment options which now includes FUS.
“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 F. 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.”
Both companies began distribution of the technology in the US in November. Information on where or how to find HIFU centers across the US can be found on the websites for Sonablate and Ablatherm.
“I believe that we are at a pivotal point in prostate care,” adds 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 and Ablatherm, several other systems for focused ultrasound ablation of prostate tissue are commercially available or being researched in other countries, with differing guidance methods (ultrasound vs. magnetic resonance imaging) and approaches (transrectal or transurethral).