Two Focused Ultrasound Systems Now Approved for Treating the Prostate in the US
Men in America will no longer have to travel out of the country to receive focused ultrasound (HIFU) 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 HIFU is commercially available for treating the prostate.
“This is a milestone for non-invasive prostate care and a tremendous gain for men’s health,” said Mark Carol, MD, CEO 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.”
|"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."
– Neal Kassell, MD, Focused Ultrasound Foundation chairman
Marc Oczachowski, EDAP's CEO 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.”
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