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• International HIFU is committed to creating a new standard for the treatment of prostate cancer and prostate disease with high intensity focused ultrasound (“HIFU”) therapy through the distribution and use of Sonablate® 500 (“Sonablate”) medical devices where approved, authorized or otherwise permitted for such uses outside the U.S.
• International HIFU is a subsidiary of USHIFU, LLC (“US HIFU”), a privately held healthcare company focused on treating diseases, such as prostate cancer, with minimally invasive HIFU technologies.
• HIFU for prostate cancer with the Sonablate (“Sonablate HIFU”) is not approved for commercial use in the U.S. It is investigational and being studied currently in two clinical trials, one for patients with recurrent prostate cancer following initial treatment with radiation (EBRT) and another for newly diagnosed patients who have not received any other treatment.
• International HIFU’s treatment program enables U.S. patients and physicians to gain access to the technology in nearby offshore locations where it is already approved or authorized and available, including Nassau, Bahamas; Cancun and Puerto Vallarta, Mexico; Bermuda; and Toronto, Niagara Falls, Montreal and Winnipeg, Canada.
• Sonablate HIFU can be found in additional areas such as Argentina, Australia, Brazil, China, Dominican Republic, Europe (Austria, France, Germany, Hungary, Italy, Romania, Russia, Spain, United Kingdom) India, Iran, Japan and Vietnam.
• When HIFU energy is delivered to a specific location within the body, the tissue temperature at that site, or focal point, is elevated to nearly 195 degrees Fahrenheit in a matter of seconds, resulting in tissue destruction.
• Tissue outside the focal point remains unharmed.
• Unlike radiation, HIFU uses clean, or non-ionizing, energy, so the procedure may be repeated if necessary without damaging healthy tissue.
• HIFU is being studied around the world to treat all types of cancer and soft tissue diseases.
• Focus Surgery, Inc., another US HIFU subsidiary, developed the Sonablate system to treat localized prostate cancer and benign prostatic hyperplasia (“BPH”) with HIFU in countries where it is approved or authorized for use.
• During Sonablate HIFU, physicians obtain real-time ultrasound images of the prostate and surrounding areas. From these images, they can create a customized plan for delivering the ultrasound energy. The Sonablate software allows physicians to precisely define the treatment zones in order to treat all prostatic tissue in the gland. • Sonablate HIFU is minimally invasive, performed on an outpatient basis and typically lasts 2-4 hours, depending on the size of the prostate. There is no surgery or radiation involved. Patients wear a catheter post-procedure but are able to resume normal activities almost immediately.
• The Sonablate can treat prostates up to 40 grams without an advance surgical procedure (known as a TURP) in order to achieve effective results.
• The Sonablate incorporates three-dimensional imaging for enhanced visualization.
• The newest technological enhancement to the Sonablate is called TCM, or tissue change monitoring, which gives real-time feedback to the physician regarding changes in tissue both before and after HIFU is delivered.
• There are nearly 400 trained Sonablate users worldwide.
• More than 10,000 patients have undergone Sonablate HIFU outside the U.S.
• The Sonablate 500 is approved for investigational use within the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. The FDA has made no decision as to the safety or efficacy of the Sonablate 500 for the treatment of prostate cancer. Currently, the device is available for the treatment of prostate cancer outside the U.S. in more than 30 countries.
What is HIFU?
HIFU stands for high intensity focused ultrasound, which is a minimally invasive technique for treating disease with precise, focused ultrasound waves that, when delivered, raise the temperature of the target tissue to nearly 195 degrees Fahrenheit in 2-3 seconds. This rapid-firing heat destroys the targeted tissue but leaves the surrounding tissue intact.
What is HIFU with the Sonablate® 500?
The Sonablate 500 (“Sonablate”) is medical device designed to treat prostate cancer and benign prostatic hyperplasia (“BPH”) with HIFU energy. The Sonablate captures real-time images of the prostate gland, allowing the physician to create a customized treatment plan for each patient. The physician then uses the Sonablate to deliver the ultrasound energy to extremely small target sites, or focal points, throughout the prostate gland.
HIFU with the Sonablate (“Sonablate HIFU”) is a minimally invasive, outpatient treatment choice for prostate cancer; it does not involve surgery or radiation.
How exactly does Sonablate HIFU treat prostate disease?
Since HIFU destroys tissue at each targeted focal point throughout the prostate, the entire gland is ablated at the conclusion of the procedure, while healthy structures outside the gland remain unharmed. HIFU uses non-ionizing, or clean, energy so the procedure may be repeated if necessary without damaging other tissue.
What are the results of the Sonablate HIFU treatment?
Sonablate HIFU has been used outside the United States for more than 10 years and international published studies show promising results as a cancer treatment that may well reduce risk for significant side effects, such as incontinence and impotence, often common with more aggressive modalities.
What are the recovery times and side effects of Sonablate HIFU for prostate cancer?
Patients can typically return to their normal lifestyle within a few days after the 2-4 hour procedure. Recovery involves wearing a catheter for approximately 2-3 weeks (varies according to each patient). All medical procedures have risks and benefits; all potential side effects and complications should be discussed with a physician prior to undergoing any procedure.
Does HIFU treat only the cancer cells? How?
Standard Sonablate HIFU treats the entire prostate gland by targeting tissue in overlapping treatment zones. The tissue is heated rapidly in targets, also known as lesions, throughout the entire gland until it is completely ablated.
Focal HIFU, on the other hand, involves treating only the cancerous part of the prostate with HIFU. Focal HIFU may be suitable for patients who have a single tumor within the gland or for patients with multiple tumors that all reside on the same side of the gland.
What is the history of HIFU and how long has it been used?
Research on HIFU began in the 1950s at Indiana University (IU) in Indianapolis, IN. In 1994, Dr. Michael Marberger and Dr. Stephan Madersbacher performed the first human prostate cancer study at the University of Vienna in Austria using the Sonablate® 200. They treated 29 human prostates in the body before performing a radical prostatectomy in order to see if the energy delivered was enough to
destroy the targeted tissue. The study found that treatment could be performed safely and be repeated if necessary.
Other significant dates and milestones include:
• 1995—a study done at IU showed that the whole prostate could be treated without damaging the prostate capsule or rectal wall.
• 1999—Dr. Toyaki Uchida began treating patients using the Sonablate 200, the first generation of the Sonablate device.
• 2001—The Sonablate 500 received its CE mark (approval for use) in Europe.
• 2004—US HIFU was founded and began placing Sonablate devices in different areas where HIFU was approved or authorized. (Complete list of locations where Sonablate HIFU can be found is below.)
• 2005—Health Canada approved the Sonablate 500.
• 2006—The first Sonablate HIFU procedures were performed in Toronto, Canada.
• 2008—Sonablate HIFU was first performed in India.
• 2010—US HIFU gained European distribution rights for Sonablate technology.
Is Sonablate HIFU unique?
Scientists have engineered the Sonablate in an effort to provide a customized, effective and safe treatment. Some unique Sonablate features include:
• The Sonablate is the only HIFU device that can treat prostates up to 40 grams without an advance surgical procedure (known as a TURP) in order to achieve effective results.
• Treating physicians are in control of the Sonablate’s power settings and can adjust them based on real-time feedback after delivery of the ultrasound energy, an innovative software feature known as TCM, or tissue change monitoring.
• Each lesion produced by the Sonablate’s energy delivery is 10-12mm in length, smaller than other prostate cancer HIFU devices, which can allow for greater precision and conformity in small, critical spaces around the gland.
• The Sonablate has real-time, three-dimensional imaging, enabling the physician to detect even slight movement of the device or gland, which could compromise treatment.
• The Sonablate uses a fully integrated probe with two transducers, one to image the prostate gland and the other to treat with HIFU.
Where is Sonablate HIFU available now?
The Sonablate 500 is approved for investigational use within the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. The FDA has made no decision as to the safety or efficacy of the Sonablate 500 for the treatment of prostate cancer. Currently, the device is available for the treatment of prostate cancer outside the U.S. in more than 30 countries.
Through International HIFU, one of US HIFU’s subsidiaries, U.S. patients and physicians travel each month to gain access to the technology in nearby offshore locations where it is already approved or authorized and available, including Nassau, Bahamas; Cancun and Puerto Vallarta, Mexico; Bermuda; and Toronto, Niagara Falls, Montreal and Winnipeg, Canada.
Sonablate HIFU can be found in additional areas such as Argentina, Australia, Brazil, China, Dominican Republic, Europe (Austria, France, Germany, Hungary, Italy, Romania, Russia, Spain, United Kingdom) India, Iran, Japan and Vietnam.
Entire article content copyright (c) 2012 USHIFU, LLC. The International HIFU logo is a service mark of USHIFU, LLC. Sonablate is a registered trademark of Focus Surgery, Inc. and used with permission from International HIFU. The Sonablate® 500 is an investigational device limited by Federal Law to investigational use in the United States.