EDAP TMS SA reports that patients with prostate cancer are being successfully treated at the St-Augustin Urology Clinic in Bordeaux, France utilizing the company’s Ablatherm High Intensity Focused Ultrasound system. Dr. Thierry Piechaud, partner and urology surgeon at the clinic, noted, "We are very enthusiastic about adding the Ablatherm-HIFU device to our therapeutic arsenal. We believe HIFU has developed a clear lead among other current technologies as a new approach and a modern concept of non-invasive treatment for early stage prostate cancer which preserves patient quality of life." EDAP reports that there are 278 Ablatherm installations worldwide.
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Recent comments by executives of EDAP TMS and US HIFU indicate that interest in focused ultrasound treatment for prostate cancer is increasing among members of the American Urological Association. Marc Oczachowski, Chief Executive Officer of EDAP TMS, said that the company “experienced record attendance and exceptional enthusiasm from U.S. urologists” at its exhibit booth at the AUA meeting, which was held May 19–23, 2012 in Atlanta. He noted that “awareness levels are building” as the company prepares for to submit its Ablatherm-HIFU filing to the US FDA later this year.
Mike Klein, US HIFU Chief Executive Officer said, "We have an unprecedented number of meetings scheduled at AUA.” He added that the company, which is conducting US clinical trials of its Sonoblate system, was “actively seeking insight from urologists to guide the development of HIFU technologies to further enhance the safety and efficacy and identify areas of interest to focus studies and clinical trials for a wide range of applications." READ PRESS RELEASE
Watching patients suffer from metastatic prostate cancer motivatedSarfraz Ahmad, MBBS, PhD, MRCSI, MRCSEd to pursue a career in urological surgery. His belief in focused ultrasound’s ability to help those patients propelled him to apply for a two-year Foundation fellowship, which he received in August 2011.
In his fellowship application, Ahmad wrote: “I truly believe that treatment based on the principles of ultrasound energy has a great future. This is not only a minimally invasive intervention but also can be repeated without any significant side effects. This is in contrast to current treatment options such as radiotherapy and use of opoids as pain killers. I am committed to academic urology with a focus on MRgHIFU treatment in localised and metastatic prostate cancer treatment.”
Since installing an ExAblate 2100 system in May 2010, Sapienza University of Rome has emerged as a driving force for the European focused ultrasound community. Within six months of opening, its clinical team had treated 15 patients with uterine fibroids and was involved in clinical trials for prostate, breast and pancreatic cancer. In fact, the center was the first in the world to use MR-guided focused ultrasound to provide pain palliation for patients with primary pancreatic cancer.
The special symposium will provide day-long programs dedicated to education, therapy and diagnoses. Scheduled for August 2, the session on therapy is being organized by Christian Diederich, PhD, Director of the Thermal Therapy Research Group at the University of California San Francisco. His collaborator is Stanley Benedict, PhD, Associate Professor and Director of Radiological Physics at the University of Virginia.
Clinician interview: Matthias Matzko, MD, Amper Kliniken AG, Dachau, Germany
Matthias Matzko, MD has emerged as a leading European advocate for MR-guided focused ultrasound. In his native Germany, he has also played a key role in eliminating one of the most challenging barriers to widespread adoption of the promising medical technology: reimbursement.
Head of Interventional and Diagnostic Radiology at the 450-bed Amper Kliniken AG in Dachau, Matzko learned about focused ultrasound in 2008 from a colleague. He admits to becoming “kind of infected” with enthusiasm for the technology after visiting Wladyslaw Gedroyc, MD at St. Mary’s Hospital in London.
Matzko immediately recognized the potential of focused ultrasound and wanted to offer it at his hospital’s Myomzentrum, a center for the treatment of uterine myoma (fibroids), which had opened in June 2008. The center was already performing uterine artery embolization, myomectomy and hysterectomy.
“When I came back from London, I was very excited about the technology, and I was thinking about how to implement this in our environment,” he recalls. “Talking with the hospital administration, they were unsure about investing in the risk of a new method.”
De-risking equipment acquisition
So strong was his conviction, the business-savvy Matzko offered to rent a focused ultrasound system through an imaging company he heads and have it set up in the hospital. “I took the risk off the hospital administration,” he says. Arrangements were made through GE Financial to lease an ExAblate System from InSightec, Ltd.
At first, Matzko and his team performed focused ultrasound procedures only on Wednesdays and Saturdays, during time slots when the Myomzentrum’s MRI was made available to them. They performed five to ten treatments a month. As more patients learned about the availability and benefits of focused ultrasound, the center’s monthly treatment volume increased to 10-12 patients. “Our machine was fully booked in advance for about a four-month period of time,” Matzko explains.
Careful patient selection aids reimbursement
From the start, Matzko and his colleagues were convinced that careful patient selection was essential to achieving good results with focused ultrasound. Only a third of their uterine fibroid patients met the treatment criteria. “When you want to have reimbursement for such a new method, you have to produce good results, and that’s why you have to select patients very carefully,” he says.
With good results and patient satisfaction documented, Matzko and colleagues applied for reimbursement from Techniker Krankenkasse (TK), one of the largest insurance companies in Germany. Company representatives visited Amper Kliniken and focused ultrasound treatment sites in Berlin and Bochum.
Matzko says two factors were of greatest interest to the insurance company: 1) that only patients suited for focused ultrasound were treated with it; and 2) the Myomzentrum’s interdisciplinary team, which includes a gynecologist who provides both treatment and information to patients.
Although pleased with both the clinic’s results and services, the insurance company raised a red flag. The capacity to treat only three patients a week seemed too limited to qualify for reimbursement from a nationwide insurer.
Rather than a barrier, this objection became the basis of collaboration between the clinic, the insurance company and – ultimately – Amper Kliniken’s administration. Together, they planned the expansion of the existing focused ultrasound center. By this point, Matzko explains, “The hospital administration was convinced about the method of focused ultrasound and convinced about the business model.”
The expanded center opened in March 2010 with a fully dedicated MRI and ExAblate 2000. By then, the two largest German medical insurers were covering MR-guided focused ultrasound treatments. With all the pieces in place, the center’s monthly treatment volume quickly doubled.
The Dachau clinic continues to be on the leading edge of focused ultrasound technology. In November 2010, it became one of the first sites in the world to install the ExAblate One, the second generation system developed by GE Healthcare and InSightec. In the future, Matzko plans to expand treatment offerings to include new applications of the technology.
Marketing is another key to success
Matzko acknowledges that marketing was initially a challenge for the focused ultrasound center. “We started in a typical radiological manner,” he says. “We did marketing to referring physicians, and we informed all of our gynecologist colleagues in the south of Germany, in Switzerland, in Austria about our new center. The result was very poor.”
Recognizing that a strategy switch was in order, the center began marketing directly to patients via a new website and the use of Google ads. Increased patient requests for information led to the creation of a 24-hour hotline staffed by two patient managers knowledgeable about uterine fibroid treatment options. “Our aim is to figure out the ideal method to treat the personal situation of the patient,” Matzko explains.
In addition to Germany, Austria and Switzerland, the Dachau clinic is attracting patients throughout Eastern Europe and elsewhere. “They come from Poland, from Russia, from Bulgaria and even we had one patient coming in from Dubai,” Matzko notes. “We now have, in a small hospital like ours, an international customership.”
The Focused Ultrasound Surgery Foundation has awarded a $232,808 research award to Wladyslaw M. Gedroyc, M.D. of St. Mary’s Hospital in London for a two-year randomized clinical trial comparing MR-guided focused ultrasound with radiofrequency ablation in the treatment of back pain caused by facet joint disease.
The clinical trial marks the next step in Gedroyc’s pioneering efforts to develop a noninvasive treatment for facet joint disease that provides more complete and longer lasting pain relief than current therapies. He and his team at St. Mary’s Hospital have already conducted a non-randomized pilot clinical trial in which MR-guided focused ultrasound was used to treat 17 patients suffering from extreme back pain caused by facet joint osteoarthritis. Post-treatment assessments show the technology is safe and effective. Click hereto read full story and watch video interview.
Clinical trials using MR-guided focused ultrasound to treat uterine fibroids and pain from cancer that has metastasized to bones are enrolling patients at the University of Virginia Health System. Details of those studies are reported in the latest issue of the UVA edition of Physician’s Practice Magazine.Click below to view the full report.
UVA Physicians Practice Magazine Article
Researchers are using new generation of MR-guided focused ultrasound equipment to treat patients with uterine fibroids and pain from metastatic bone tumors.
Dedicated in September 2009, the Foundation-sponsored Focused Ultrasound Center of Excellence at the University of Virginia Health System in Charlottesville has taken the first steps in building a robust, multi-disciplinary clinical trial program.
Executive Perspective: Falko Busse, PhD, Philips Healthcare
Asian markets are leading the adoption of focused ultrasound, reports Falko Busse, PhD, vice president and general manager of MR-HIFU for Philips Healthcare.
Trained as a neurologist, Thilo Hoelscher, M.D., has travelled a long way from his native Germany and his early clinical experiences at that country’s first stroke unit. Now an assistant professor in the Departments of Radiology and Neurosciences at the University of California San Diego, he is Director of its Brain Ultrasound Research Laboratory and working once again on the forefront of medicine.
As a researcher and clinician, Hoelscher has extensive experience in using transcranial ultrasound as a diagnostic tool. In 2007, he learned about high intensity focused ultrasound and became intrigued with its potential to treat the human brain. Since then, he has completed hundreds of preclinical experiments with FUS and concentrated on developing therapies based on a clot-busting technique, transcranial sonothrombolysis. He recently received a multi-million dollar grant from the National Institutes of Health to study sonothrombolysis as a treatment for ischemic stroke.
Hoelscher, who received a FUSF fellowship in 2009, expects to begin pilot clinical trials in 2011 using FUS to treat stroke and believes success is inevitable. “Once it is approved for use in patients, FUS will be without equal – it will have no competition. In treating ischemic stroke, for example, it will dissolve blood clots and restore blood flow within seconds. Drugs like tPA won’t be necessary,” he says.
Hoelscher’s work has moved beyond exploring the thermal ablative capabilities of FUS to assessing its use in precise drug delivery and its ability to induce cellular mechanisms.
Noting that the pace of FUS research is accelerating, he says. “Our work has been booming during the last six to eight months. Everything has started to progress rapidly. Researchers from all over the place are interested in focused ultrasound. Ideas and new collaborations are popping up everywhere.”
The University Children’s Hospital in Zurich, Switzerland recently celebrated treating its tenth neurosurgery patient with focused ultrasound. The patient had suffered for almost ten years from neuropathic pain – pain that originated when a benign brain tumor damaged nerve fibers in his brain which led to extreme pain and cramping in his right arm.
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