Focused Ultrasound for the Treatment of Prostate Cancer

Focus Surgery, Inc. (FSI; Indianapolis, IN, USA), the developer of the HIFU system used in this study, the Sonablate 500, has announced that the U.S. Food and Drug Administration (FDA) granted the device a provisional Investigational Device Exemption (IDE), which will allow the device to be used in this multicenter clinical study to collect safety and efficacy data for final FDA approval. The study will enroll approximately 466 subjects at 24 institutions.

"We are excited by the news from the FDA and by the continued progress of the Sonablate 500 as demonstrated by our successful completion of the FDA- approved pilot study. The HIFU technology utilized by the Sonablate 500 was developed in collaboration with the Indiana University School of Medicine [Indianapolis, USA], which is one of the planned study sites,” said Narendra T. Sanghvi, CEO and president of FSI. "The ability to proceed with the FDA pivotal study is the most significant milestone achieved by Focus Surgery to date.”

HIFU is a targeted, precise treatment that uses sound waves to rapidly heat and kill targeted tissue while sparing the surrounding tissue. The Sonablate 500-HIFU device uses real-time ultrasound image guidance for the treatment of prostate cancer. This non-invasive procedure is performed on an out-patient basis and international studies suggest a significant reduction in typical side effects such as impotence and incontinence.

Although the Sonablate 500 system is still in clinical trials in the United States, it is already approved in Canada, Europe, and Asia. The device is manufactured by Misonix, Inc. (Farmingdale, NY, USA), who also holds distribution rights in Europe.



Related Links:
Focus Surgery
Misonix