Sonablate® 500 for Prostate CA

A recent article in the New York Times profiles a growing interest among patients for high-intensity focused ultrasound, or HIFU, for the treatment of prostate cancer. The therapy, profiled on these pages before (see flashbacks below), has not been approved by the FDA for prostate CA treatment, but the leading manufacturer of HIFU equipment, Misonix, Inc. of Farmingdale, NY, that makes a system called Sonablate® 500, hopes it has a chance since its already sold in Europe and elsewhere.
From the company’s website:

HIFU has the potential to achieve this by virtue of the size of the target lesion that it creates. HIFU works by focusing a pulse of high-energy ultrasound waves onto single location about the size of a grain of rice. The delivery of this energy to such a small area results in an increase in temperature to a point where the lipids (fats) in the cell membrane melt and the proteins denature. A reproducible but small volume of tissue destruction occurs. The distribution of these target lesions is under the control of the physician. During the planning phase of the treatment, ultrasound is used to delineate the prostate in two dimensions. Targeting can be planned in order to avoid the urinary sphincter, rectum, and possibly the neurovascular bundles (as preservation of these may preserve erectile function). Once the treatment plan is established, the treatment is both driven and monitored by a computer program within the HIFU delivery system.
Treatment time is usually 3-4 hours. Usually patients will be discharged the same day, or next day at the doctors discretion.
An important difference between HIFU and many other forms of focused energy, such as radiation therapy or radio surgery, is that the passage of ultrasound energy through intervening tissue has no apparent cumulative effect on that tissue.

And from the press release:

HIFU has been gaining momentum around the world as an acceptable alternative procedure. We are very pleased with the progress being made educating men on the results that are being realized with a HIFU procedure. There have been more than 10,000 procedures using HIFU throughout the world. Results with the latest technology show that HIFU can eradicate the cancer and demonstrate the same or better results with regard to incontinence and impotence. We hope that ongoing clinicals in the U.S. will result in the approval of HIFU by the FDA as an approved choice. We believe most people understand that important new technology will not, by definition, have ten years of reported results. We are excited about the acceptance of HIFU as a treatment for prostate cancer…
The SB500 has been used in over 5,000 procedures worldwide. In a study previously announced by Misonix, prostate cancer treatment using the latest advancements for the SB500 showed successful outcomes that exceeded published reports for other HIFU devices and rivaled that of traditional surgical treatment. Important advantages of the SB500 over traditional surgery include that it is a non-invasive procedure that is performed on an out-patient basis and that, because it does not involve radiation, it can be repeated if necessary. The SB500 can also be used to retreat patients who received unsuccessful radiation treatment.

Press release: New York Times Front Page Story Features HIFU Prostate Cancer Treatment with Sonablate 500 from Misonix …
Product page: Sonablate …
Flashbacks: Ultrasound That Seals Punctured Lungs ; High Intensity Focused Ultrasound for AFib; Ultrasonic Tourniquet (with HI-FU Grip); Deep Bleeder Acoustic Coagulation, aka Autonomous Acoustic Hemostasis; High Intensity Focused Ultrasound (HIFU) for Body Sculpting;