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One study showed that non-invasive treatment with the ExAblate MagneticResonance-guided Focused Ultrasound (MRgFUS) system offers women asignificantly less risky treatment for symptomatic uterine fibroids with muchfaster recovery time than hysterectomy. A separate study shows the positivecorrelation in the volume reduction of the fibroid to symptom improvementafter two years, while a third showed improvement in outcomes of ExAblatetreatments as physicians improved their skills with the system.
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"Our understanding of how to apply this new technology in the treatmentof uterine fibroids has been rapidly expanding," wrote Prof. Wladyslaw M.Gedroyc, St. Mary's Hospital, Imperial College Healthcare Trust, London, UK,in an Opinion published in the November issue. "We now know that MRgFUS worksquickly with very few side effects and that patients can return to normalfunction almost immediately after treatment. We also know that the larger thearea of ablation that can be produced in the targeted fibroids, the betterthe symptomatic response and the less the need for other fibroidinterventions, and that when the early symptomatic response is highlyeffective, long-term improvement of symptoms is almost invariably seen,"
A prospective study of 192 patients at 14 different medical centersacross the United States, Israel, the United Kingdom and Germany, showed thatMRgFUS was associated with significantly fewer adverse events in comparisonwith hysterectomy patients. Similarly, recovery times were much faster forMRgFUS, with an average of only one day away from work as opposed to 6 weeksfor hysterectomy
In a separate retrospective multi-center study of patients who hadundergone MRgFUS in Japan, researchers found that as practitioners gainedmore experience using MRgFUS, their treatments were increasingly effectiveand that the percentage of patients that who required a second treatment atone year decreased significantly, from 12% in the first group to 5% in thepatients treated later. These numbers are similar to the retreatment rates ofother uterine-conserving solutions.
Another Japanese study, from Shinsuma Hospital, showed that differenttypes of fibroids respond differently to MRgFUS. Low-intensity T2 signalfibroids respond extremely well, with large areas of destruction being easilyproduced which lead to large Non-Perfused Volumes (NPVs). In comparison,fibroids of high intensity T2 signal do not respond as well to MRgFUS. As aresult, at 12 months only 2.9% of the patients treated with low intensityfibroids required retreatment and 14% at 24 months, compared to 22% at 24months for high intensity group.
Over 5,000 patients worldwide have already benefited from the ExAblatetreatment which is the only U.S. Food and Drug Administration (FDA)-approvedsystem to use the breakthrough MRgFUS technology that combines MRI -- tovisualize tissues in the body, plan the treatment and monitor, in real time,treatment outcome -- and high intensity focused ultrasound to thermallyablate tissue. MR thermal feedback, provided uniquely by the system, allowsthe physician to control and adjust the treatment in real time to ensure thatthe targeted tumor is fully treated and surrounding tissue is spared.ExAblate received the CE Mark for uterine fibroids in October 2002 and FDAapproval for the treatment of symptomatic uterine fibroids in October 2004.
"The non-invasiveness of the MRgFUS procedure and its ability to rapidlyrestore patients to an improved function are very strong advantages and theconversion of hospital inpatient stays into outpatient procedures is veryattractive economically given the rapid gain in quality of life post-therapy,with few complications," Dr. Gedroyc concluded in the editorial.
About Uterine Fibroids
Uterine fibroids are benign growths in the uterus that affect one in fourwomen of childbearing age. Uterine fibroids can cause heavy bleeding thatleads to anemia, bloating, abdominal pain, and other symptoms. Each yearhundreds of thousands of women worldwide have hysterectomies to treat uterinefibroids. Unlike hysterectomy, myomectomy and UAE, ExAblate is completelynon-invasive, using MR guided focused ultrasound to thermally ablate(destroy) growths in the uterus. For women this means no hospital stay andonly one to two days of recovery as opposed to one week (UAE); two weeks(myomectomy); or six weeks (hysterectomy) usually associated with treatmentof this condition.
About ExAblate(R)
ExAblate is the first system to use the MR guided focused ultrasoundtechnology that combines MRI - to visualize the body anatomy, plan thetreatment and monitor treatment outcome in real time - and high intensityfocused ultrasound to thermally ablate tumors inside the body non-invasively.MR thermometry, provided uniquely by the system, allows the physician tocontrol and adjust the treatment in real time to ensure that the targetedtumor is fully treated and surrounding tissue is spared. The ExAblate systemwas approved by the U.S. Food and Drug Administration in 2004 as a treatmentfor symptomatic uterine fibroids. Over 5,000 women have been treatedworldwide to date. ExAblate(R) 2000 received the European CE Mark for painpalliation of bone metastases in June 2007.
About InSightec
InSightec Ltd. is a privately-held company owned by Elbit Imaging,General Electric, MediTech Advisors, LLC and employees. It was founded in1999 to develop the breakthrough MR guided Focused Ultrasound technology andtransform it into the next generation operating room. Headquartered nearHaifa, Israel, the company has over 160 employees and has invested more than$120 million in research, development, and clinical investigations. Its U.S.headquarters are located in Dallas, Texas. For more information, please goto: http://www.insightec.com/Media Contact: Hollister Hovey Lazar Partners +1-646-871-8482 [email protected]
SOURCE InSightec Ltd
