How does HIFU work?

In order to understand the basic concept of how HIFU works, an analogy can be drawn between HIFU ablating the prostate and sunrays entering a magnifying glass to burn a leaf. When a magnifying glass is held above a leaf in the correct position on a sunny day the sunrays intersect below the lens and cause the leaf to burn at the point of intersection.

If you insert your hand into the path of either one of the sun rays individually, away from the point of intersection, there is no significant heat felt or harm caused. Alternatively, if you place your hand at the point of intersection you will be burned.

The scientific principles at work in this example are the same as those with HIFU. Instead of light as the energy source, HIFU utilises sound. Instead of a magnifying glass HIFU uses a transducer. Just as the individual sunray is harmless to the hand, and individual sound wave is harmless to the healthy tissue it travels through.

During HIFU treatment, the surgeon uses continuously updated real-time images of the prostate to map out and execute the entire treatment plan. These images show treatment progression and permit the physician to customise treatment for maximum safety and effectiveness.

What is the Sonablate 500 and how does it treat Prostate Cancer?

The Sonablate® 500 (SB500) is a non invasive medical device, developed by Focus Surgery that uses High Intensity Focused Ultrasound (HIFU) to treat prostate cancer and BPH.

The Sonablate® 500 is the choice for HIFU Worldwide.

The Sonablate® is the only truly non invasive prostate cancer treatment that does not require a TURP procedure prior to treatment in order to achieve effective results.

The Sonablate® uses a single transducer to obtain real-time images of the prostate during treatment and provide treatment in three treatment zones from top to bottom, and two treatment zones from side to side. The Sonablate® software allows the surgeon to customise each of the six treatment zones in order to safely ablate the entire gland.

This image illustrates in the Sector (Transverse) and Linear (Longitudinal) view how the Sonablate® 500 HIFU beam is precisely focused and delivered into the prostate gland. (image courtesy of Takai Hospital Supply Co., Japan)

The technology behind the device originated at Indiana University School of Medicine in Indianapolis in the 1970s. It was further developed in leading research centres across the globe.

IMAGE.

Non invasive prostate disease therapy with the SB500 begins with IMAGING of the prostate. The surgeon is able to plan the treatment with the Simul-PlanTMTherapy Planning which allows the selection of specific areas for treatment.



CLICK.

With HIFU, surgeons can select targeted tissue, and with the click of a mouse initiate split beam HIFU which is emitted through the same transducer used for treatment planning.

In countries where HIFU is approved to treat localised prostate cancer, 87% of patients are cancer free after five years. Side effects are 75% less likely with HIFU than with other conventional treatments for prostate cancer.

For more details about prostate cancer treatment with the Sonablate® 500 visit Focus Surgery online at www.focus-surgery.com.

About the Sonablate 500

The advanced High Intensity Focused Ultrasound (HIFU) technology resident in the Sonablate® 500 originated over 25 years ago at the Indiana University Medical Center, and has been developed at leading research centres across the United States, Europe and Japan. HIFU is a state-of-the-art technology utilising the power of ultrasound to destroy deep seated tissue without affecting the surrounding healthy tissue. The HIFU energy is focused sharply from the transducer surface to the targeted tissue in the prostate. Temperature is elevated in the targeted tissue up to 90°C within one second causing cell death. The treatment consists of placing HIFU lesions (each requiring only a few seconds to create) side-by-side until the entire desired volume is treated.

Now the urologist can plan the treatment under ultrasound image guidance, target the prostate and monitor the therapy, all using a single transducer and probe. This design provides maximum precision, flexibility, safety and control for the clinician.

HIFU energy is focused by a patented transducer which integrates ultrasound imaging and therapy in a single device.

DESIGN PHILOSOPHY

The Sonablate® 500 system (SB-500) is a medical device that uses high intensity focused ultrasound (HIFU) to non-invasively ablate prostatic tissue under imaging ultrasound guidance to treat localised prostate cancer.

It consists of a main console, ultrasound transrectal probe (HIFU and imaging), a pump/chiller unit (SonachillTM), and a probe arm.

System Concept

The Sonablate® system concept for the treatment of prostate tissue has been validated through computer simulations, laboratory measurements, in-vitro tissue experiments, in-vivo animal model measurements, and, most importantly, many clinical trials and clinical procedures around the world (under local and national regulatory approvals). The test procedures used during the manufacturing activities of the device have also been validated and shown to be appropriate to ensure its correct operation.

Sonablate® system design, test, and validation activities started in the late 1980's, and are documented through a long series of patents [1-4], scientific (both technical and clinical) publications in peer-reviewed journals [5-18], and test procedures. Since that time, the Sonablate® system has gone through 3 distinct design iterations: the Sonablate® 1 (initial prototype and original proof of concept, 1992), the Sonablate® 200 (clinical system for the treatment of BPO, 1995), and the Sonablate® 500 (current generation, with commercial production starting in 2001).

Throughout that time, the basic Sonablate® system concepts of:

1. utilising HIFU to non-invasively ablate prostatic tissue
2. while using imaging ultrasound for treatment planning and monitoring and
3. using a transrectal probe with therapy and imaging capability that is
4. fixed to the patient table using a probe arm

has remained unchanged. Incremental design changes and changes in the manufacturing test procedures have been incorporated as advancements in technology became available, based on user feedback, based on clinical results, and because of Focus Surgery's commitment to the design, manufacture, and the delivery a safe and quality product.

The most critical component of the Sonablate® system, namely its HIFU delivery transducer with con-focal imaging transducer has remained unchanged since its introduction in the SB-1, and small changes made to the transducer housing assembly have not changed its therapeutic and imaging performance. The transducer excitation parameters (HIFU delivery ON/OFF time, and total acoustic power levels) have been changed to improve speed of the HIFU procedure.

This fact allows the use of accumulated historical technical, clinical, and test/validation data obtained from the previous Sonablate® devices to validate the manufacture, operation, functionality and safety of the current SB500 system.

The system evolution of the Sonablate® and its transrectal probe.

Sonablate® system evolution. Note the constancy of the overall transrectal HIFU treatment approach with image guidance, technology-driven changes in the console, and therapeutically unchanged transrectal probe.

The transrectal approach to the treatment of prostate disease was chosen for the Sonablate® system since it provides an ideal arrangement for focused ultrasound because it permits a non-sterile procedure, is free from haemorrhage and significant trauma, and offers the potential of being performed again in the case of cancer or benign recurrence.

The Sonablate® 500 system combines proprietary multi-focal length transducer technology in a custom, transrectal imaging and therapy probe. This system uses ultrasound imaging for treatment planning and monitoring, and Split-Beam HIFUTM and Single-Beam HIFUTMfor targeted, noninvasive tissue treatment. The proprietary HIFU Simul-planTM therapy treatment software allows the surgeon to select multiple treatment zones as necessary for a doctor-directed, computer-controlled treatment. A new colour-coded overlay planning system with enhanced prostate visualisation simplifies the process. The active cooling and circulation system, the Reflectivity Index Measurement (RIM™) and real-time Rectal Wall Distance Measurement (RDM™) software features provide for treatment safety. A slim, space-saving cabinet with a reduced footprint has been matched with a 17-inch, flat panel monitor with 1280 x1024 high-resolution capability and an articulated monitor arm for ease of use and volumetric prostate visualisation ProVol™.

Sonablate®500 FEATURES and BENEFITS

Why You Should Choose the Sonablate® over Ablatherm®

HIFU MYTHS: The Truth About HIFU

MYTH: A TURP (transurethral resection of the prostate) is required before every HIFU procedure.

False. A TURP is a surgical, invasive procedure that is required by physicians using the Ablatherm® but is NOT required for HIFU with the Sonablate® 500. The reason that a TURP is not required before HIFU with the Sonablate® is because the Sonablate® 500 uses a 4.0cm focal length opposed to the 2.5 cm focal length of the Ablatherm®. This means that the Sonablate® 500 can treat with HIFU at a great depth than the Ablatherm® and therefore there is no reason why patients who choose the Sonablate® 500 would have to undergo an additional, invasive TURP, prior to HIFU.

MYTH: Several probe heads are needed to complete HIFU with the Sonablate® 500 and each must be manually placed and manipulated.

False. The Sonablate® 500 has one probe that is inserted at the beginning of HIFU. The probe has two transducers that are both located in the single probe. The transducers move independently and are controlled by Sonablate® software once the probe is placed. More than one probe is not needed to perform HIFU with the Sonablate® 500.

MYTH: Short focal length requires use of multiple probes to complete treatment. Probe geometry poorly configures to prostate anatomy.

False. HIFU with the Sonablate® 500 requires one probe. Multiple probes are not required. The single, bi-plane, transrectal probe placed in the rectum under spinal anesthesia consists of two transducers allowing for treatment using two focal lengths. The two focal lengths, 3 cm and 4 cm mean that the physician and image and treat the entire prostate gland. The Ablatherm does not have the capability of treating at more than one focal length; therefore the patient is place in a position to compress the prostate abnormally in order to treat at one focal length. Additionally the Sonablate® 500 allows the treating physician to see multiple views of the prostate including 3D images. The Ablatherm only gives the doctor one view of the prostate.

MYTH: HIFU with the Sonablate® 500 takes 3 ½ -5 hours.

On average Sonablate® HIFU takes 1-3 hours with a 1-2 hour recovery period.

MYTH: The Ablatherm® is the only HIFU device certified for use in salvage therapy for patients who experience recurrence after failure of a prior radiotherapy treatment.

False. In addition to being used as a primary Prostate cancer treatment, the Sonablate® 500 is capable of treating recurrent prostate cancer after radiation failure. In fact, it is currently being used in a FDA-approved feasibility study using HIFU to treat localized recurrent prostate cancer after external beam radiation and/or brachytherapy. The Sonablate® 500 is also being used in a similar trial in London, Ontario in Canada for treating recurrent prostate cancer. International centers in Canada, Mexico and Japan have also used protocol developed specifically for the Sonablate® 500 to treat radiation failures.

MYTH: The Ablatherm is the device most frequently used for HIFU treatment of prostate cancer throughout the world and was recognized by urologists as a device that perfectly complied with expectations of urologists.

There are over 150 urologists currently using the Sonablate® 500 worldwide who believe that the Sonablate® is a superior HIFU device than the Ablatherm®. Over 5,000 patients have been treated for prostate disease with the Sonablate® in nearly 100 Sonablate® HIFU Centers worldwide. Additionally, the Sonablate® 500 is the only HIFU device available in Central or South America and Africa. The Sonablate® 500 is the fast growing HIFU treatment for prostate cancer that is preferred by both patients and physicians because of its precision, ease of use and clinical history.

In addition to image quality, the Sonablate® 500 incorporates several features to enhance treatment accuracy. The Sonablate® 500 is able to monitor blood flow through the neurovascular bundles with a color overlay during both planning and treatment. Through detecting the blood flow, physicians can clearly see the location of the neurovascular bundles (NVB), thus avoiding them to preserve potency. The Ablatherm® is not capable of monitoring neurovascular blood flow, in fact, the Ablatherm® does not have any features at all for detecting location of the NVB.

Lastly, the Sonablate® 500 is superior because it produces a smaller, more precise lesion. Because these lesions are smaller, the physician is able to place them at the prostatic apex while monitoring the rectal wall. The Ablatherm® is only able to produce one size lesion which is 1.7 mm in diameter. It must be placed 5-8mm behind the apex; this could leave prostatic tissue outside of the treatment zone, which is undesirable and could lead to recurrence.

Unlike the Sonablate® 500, the Ablatherm® seriously lacks important features that combine with real-time imaging to ensure precise, accurate HIFU therapy.

Automated, power-guided controlled HIFU or fixed treatment means that the machine is programmed to give each patient the exact same HIFU therapy at set power levels. It cannot be adjusted or changed. Each HIFU case is the same.

The Sonablate® 500 recognizes that each patient is different and therefore it is essential for the physician to be able to customize each HIFU treatment to the patient. The Sonablate® 500 ensures physician control; it does not reply on a machine to do the work of the physician. Like with any technology, there has to be room for user interface. The Sonablate® 500 places control in the hands of the physician, resulting in a customized treatment for each patient.

During treatment with the Sonablate® 500, the physician actively monitors the real-time images which show treatment progression and is able to tailor the treatment dynamically by adjusting the HIFU power level and update the treatment plan to increase effectiveness and maintain safety. The Ablatherm does not have adjustable power levels.

MYTH: The Sonablate® 500 does not have any published clinical data with men follow ups longer than one year.

The Sonablate® has been used to treat prostate disease since the early nineties and there is a wealth of published clinical data that highlight the results of Sonablate® users. Dr. T Uchida has recently presented and published data that showed:

Years after HIFU Biochemical Disease Free Rate 1 81% 3 77% 5 77% Biochemical Disease Free Rate After 5 Years Low Risk 97% Intermediate Risk 71% High Risk 64%
Similar data has been published and presented throughout Europe and the Americas. Clinical data includes but is not limited to:

Visually Directed HIFU for Prostate Cancer --a new standard. Rowland O. Illing**, Sam Dawkins*, Chris W. Ogden* and Mark Emberton**. *Institute of Urology and Nephrology, University College Hospital, London, UK ** The Clinical Effectiveness Unit, The Royal College of Surgeons of England, London, UK

Treatment of localized prostate cancer using high-intensity focused ultrasound. Toyoaki Uchida. Dept. of Urology University of Tokai Hachioji Hospital. British Journal of Urology International 2006.

Prostate Cancer Therapy with High-Intensity Focused Ultrasound-Comprehensive Review Thomas A. Gardner and Michael A Koch, Indiana University Medical Center, Indianapolis. Clinical Genitourinary Cancer Vol 4. No.3, 2005.

Transrectal High-Intensity Focused Ultrasound in the treatment of Localized Prostate Cancer: A Multicenter Study. Acta Urol. Jpn. 51 651-658, 2005. Toyoaki Uchida. The Dept. of Urology, Tokai University Hachioji Hospital.

High Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer. A Multi-Center Experience. George M Suarez*, Miami, FL; Rafael Estrella, Santiago De los Caballeros, Dominican Republic; Carlos Garcia, Puerto Vallarta, Mexico. Abstract from Presentation given at The 15th International Prostate cancer Conference in Vail, Colorado, February 2005

Transrectal HIFU: The Next Generation? Prostate Cancer Research Institute (PCRI) Insights. Douglas O. Chinn, MD Chinn & Chinn Urology Medical Associates, Arcadia, CA February 2005. Pages 8-15.

Clinical Outcome of HIFU for the Treatment of localized prostate cancer: 5-year Experience. Toyoaki Uchida, Hiroshi Ohkusa, Hideyuki Yamashita, Yoshihiro Nagata Department of Urology, Tokai University Hachioji Hospital. Abstract - ISTU 2004

Clinical Outcome of HIFU for Localized Prostate Cancer: 5 year Observations. Toyoaki Uchida, E. Yamashita, Y. Okusa, T. Nagata, Tokai University, Tokyo, Japan. Podium presentation given at the 2004 Japan Endourology and ESWL Conference, Okayama, Japan November, 2004.

High Intensity Focused Ultrasound for Prostate Cancer: Clinical Results and Technological Evolution John C. Rewcastle, Ph.D. Department of Radiology, University of Calgary Alberta, Canada

Quality of Life in Patients with High Intensity Focused Ultrasound (HIFU) for localized Prostate Cancer. Toyoaki Uchida, E. Yamashita, Y. Okusa, T. Nagata, Tokai University, Tokyo, Japan. Podium presentation given at the 2004 Japan Endourology and ESWL Conference, Okayama, Japan November, 2004.

Transrectal High-Intensity Focused Ultrasound for treatment of patients with Stage Tib-2N0M0 localized Prostate Cancer: A Preliminary Report. Presentation of preliminary clinical results of transrectal HIFU in stage T1b-2N0M0 prostate cancer. Dr. T Uchida, M.D.

Localized Prostate Cancer Treatment by High Intensity Focused Ultrasound (HIFU) Toyoaki Uchida M.D., Department of Urology, Kitasato University, Tokyo, Japan. The Journal of Highly Advanced Medical Technology. Highly Advanced Medical Technology Research Center, Volume 15, March 2000 (Translated from Japanese and updated with current information by Focus Surgery, Inc.)

Localized Prostate Cancer Treatment by High Intensity Focused Ultrasound (HIFU): Preliminary Results. Toyoaki Uchida M.D., Department of Urology, Kitasato University, Tokyo, Japan. This summary has been abstracted from previously published work and supplemented by additional new treatment data prepared by Dr. T. Uchida, M.D. by Focus Surgery, Inc.

Noninvasive Surgery of Prostate Tissue by High Intensity Focused Ultrasound: An Updated Report. European Journal of Ultrasound. N. T. Sanghvi 2,*, R. S. Foster1, R. Bihrle1, R. Casey3, T. Uchida4, M. H. Phillips2, J. Syrus2, and A. V. Zaitsev2 , K. W. Marich2 , F. J. Fry

MYTH: The Sonablate® 500 does not have a warning system or safety features that alerts user of patient movement.

Wrong. The truth is that the Sonablate® software and hardware are designed to ensure patient safety and do not rely simply on one warning system but the entire HIFU treatment is monitored to ensure there is no possible danger to the patient.

The reality is that the safety system on the Ablatherm relies solely on an inefficient infrared warning system to detect movement of the patient. This movement system is tied to the hip of the patient and not related to the treatment area. You might have movement of the monitored area that does not affect the treatment area but that will cause an alarm. Like most infrared movement detection systems on the market they prompt many false alarms. Several environmental conditions including but not limited to movement can trigger the alarm system. A common complaint from doctors that use the system is that it gives you a lot of false alarms. Each Alarm will stop the unit and require that the unit is checked for alignment, which can extend treatment time for the patient.

However, with the Sonablate® the doctor can monitor both real-time images and references images at the same time. This means that the Sonablate® software allows him to simultaneously compare images from the planning stage of HIFU with the real-times images during HIFU. If any movement has taken place in the treatment area, then the doctor will be able to compare the images and stop treatment. The ability to be able to view both sets of images (real-time and reference) is a superior, more accurate method for identifying real movement of the prostatic tissue within the treatment zone.