Viewers of the January 23 broadcast of ABC World News with Diane Sawyer learned about the highly positive impact that focused ultrasound treatment has had on the life of Phyllis Walker. She was one of the 15 patients with essential tremor who volunteered for the recent, FUS Foundation-funded essential tremor clinical trial at the University of Virginia. For Phyllis, the treatment provided a 180-degree turn in the quality of her life. Her treated hand has become steady enough to resume everyday activities, including something Phyllis considers really important – writing letters to her two grandsons who are serving in Iraq and Afghanistan. respectively.
The essential tremor study serves as an excellent example of the impact being made by the Foundation. Two years ago, a noninvasive, deep brain treatment for essential tremor was just a concept – a “big idea,” so to speak. A collaborative effort by the Foundation, industry and clinical researchers succeeded in fast-tracking this idea into reality. While much work remains in fully developing this new focused ultrasound indication, success stories like Phyllis Walker’s provide the motivation to keep pushing forward.
The positive energy surrounding the field of focused ultrasound has reached unprecedented levels. During the last 60 days, recognition by TIME magazine and ABC World News as well as viewership of the TEDMED video have caused "an explosion in public awareness of the promise and potential of this revolutionary technology," according to FUS Foundation Chairman Neal F. Kassell, MD. As a result, he says, demand for rapid development of focused ultrasound treatments is greater than ever before.
Kassell expects momentum to continue building in the year ahead. "The pace is definitely accelerating. We anticipate that 2012 will be a year of significant developments, especially in the clinical arena," he notes.
"Focused ultrasound is an exciting new technology. We are pleased to support research into this noninvasive medical therapy which has huge potential,"says Tiger Management founder Julian H. Robertson, Jr. who established the foundation along with his wife Josie and their family.
Philips prepares for launch of U.S. pivotal trial for uterine fibroids
Philips Healthcare's Sonalleve MR-guided focused ultrasound system
Philips Healthcare is about to begin the next leg of its journey toward FDA approval of its Sonalleve MR-guided focused ultrasound system as a treatment for uterine fibroids, benign tumors that affect 20-50 percent of pre-menopausal women over 30 years old. Intent on providing a noninvasive, outpatient, quick-recovery therapeutic option to Americans with uterine fibroids, Philips will soon launch a Phase II/III study – Philips Pivotal Clinical Trial for MRI-HIFU of Uterine Fibroids – to assess the safety and efficacy of the Sonalleve system.
InSightec seeks FDA approval of ExAblate treatments for pain associated with metastatic bone cancer
A new, noninvasive treatment option may be on the horizon for cancer patients who suffer from painful metastatic bone tumors and do not respond to radiation therapy. The FDA has granted an expedited review process for InSightec' premarket approval application (PMA) for its ExAblate MR-guided focused ultrasound system in treating bone metastases. According to an InSightec press release, the PMA submission is currently under full FDA review and is based on findings of a clinical trial that randomly assigned patients to a treatment or sham group.
A highlight of the FUS Foundation's 2010 International Symposium on MR-guided Focused Ultrasound was the presence of our Young Investigators, ten early-career scientists selected to present their work during oral or poster sessions. The spirit and enthusiasm of these individuals provided a special spark that energized the entire symposium. During a recent interview, one of those Young Investigators – Urvi Vyas, PhD – provided an update on her focused ultrasound activities. The excitement and positive expectancy with which she spoke were truly inspirational.
This month's featured focused ultrasound researcher, Urvi Vyas, PhD, has made important contributions in the area of ultrasound beam propagation. Realizing that many newsletter readers may not be familiar with this process, we asked, Matthew Eames, PhD, a biomedical engineer and Senior Project Engineer for the FUS Foundation Brain Program, to provide an easy-to-understand explanation.
Resources: Information about expanded patient access to focused ultrasound treatments is now posted on FUSF website
In January 2011, this newsletter ran a story entitled, "Patient with benign pancreatic tumor experiences pain relief after MR-guided focused ultrasound treatment." The patient, 89-year-old Doris McArdle, travelled from her home in Chicago to St. Mary' Hospital in London. There, she received treatment on a compassionate use basis from Wladyslaw Gedroyc, MD, a radiologist and highly regarded focused ultrasound pioneer.
Following the successful treatment, McArdle's daughter Sharon Duffy reported, "The hardest part of the whole undertaking was the travel to and from London and dealing with jet lag."
McArdle's experience and Duffy's remark inspired the FUS Foundation to develop a new online resource to help clinicians quickly connect with FDA documentation for expanded access to focused ultrasound equipment. "Our goal is to provide treating physicians in the U.S. with the information they need to become better educated about this option," explains Robin Jones, FUS Foundation Director of Clinical Trials Coordination. "This supports our ultimate objective of making focused ultrasound available close to home for as many patients as possible."
Rome Symposium talks can now be viewed on FUSF website
Presentations from the 1st European Focused Ultrasound Symposium, held September 2011 in Rome, are now available on the FUS Foundation' website. The talks are organized into six sessions: Uterine Fibroids, Bone Tumors, Technology, Brain, Liver and Prostate. Click here to view the talks.
Ultrasonic Industry Association Annual Symposium set for April in San Francisco
Scheduled for April 16-18, 2012, the Ultrasonic Industry Association' 41st Annual symposium will be held at the Mark Hopkins Hotel in San Francisco. The meeting will feature the best of ultrasound research and development from around the world. It will cover industrial and medical applications, including high and low intensity focused ultrasound, bioeffects, tissue characterization, bio‐acoustic microscopy and transducer design and materials.
Although the abstract submission deadline has passed, the UIA is still acceptingStudent Paper applications through March 16, 2012.
The UIA is the international business forum for users, manufacturers, and researchers of ultrasonics, and its members use acoustic vibrations to improve materials, industrial processes and medical technology. Complete information about the symposium can be found at http://www.ultrasonics.org/events.html.
Focused Ultrasound Surgery Foundation | 1230 Cedars Court, Suite F | Charlottesville VA | 22902 Questions and comments about this newsletter should be sent to the Foundation's Director of Communications, Ellen C. McKenna ()