FDA approves ultrasound system for targeted prostate treatment
SonaCare Medical’s Sonablast 450 focused ultrasound system has been approved by the FDA for the removal of prostate tissue, according to a press release.
“For men with conditions like prostate cancer, the option of a noninvasive procedure that can selectively target and treat diseased tissue is very appealing. 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,” Neal Kassell, MD, chairman of the Focused Ultrasound Foundation, said in the release.
Physicians using the noninvasive, radiation-free system will use real-time image guidance to target a specific volume of the prostate. A focused beam of ultrasound energy is then directed to the area, which causes the targeted cells to thermally coagulate within seconds.
The novel system, which would allow patients to skip radiation treatment or surgery, will preserve healthy tissue while treating organ-confined prostate diseases. In the United States, focused ultrasound is currently approved for treating uterine fibroids and pain relief from bone metastases.
Globally, more than 50,000 men with prostate cancer have been treated with focused ultrasound, of which more than 50% have had their prostate disease treated. Additionally, benign prostatic hyperplasia, partial gland cancer, localized whole-gland prostate cancer and recurrent prostate cancer have all been treated successfully with focused ultrasound, according to the release.
“I believe that we are at a pivotal point in prostate care. Simultaneous advances in imaging, fusion technologies, and now more focused therapies are going to allow us to precisely diagnose 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,” Michael Koch, MD, Sonablate trial investigator and chairman of the department of urology at Indiana University, said in the release.