At least 25 percent of women suffer from uterine fibroids and as many as 77 percent of women may actually have the condition but be unaware of it, according to the U.S. National Institutes of Health. Although the tumors are benign, there are several uncomfortable and often very painful symptoms such as heavy bleeding, frequent urination, cramping and painful periods. Traditionally, treatment options have included some rather expensive hormonal treatments or even invasive surgical procedures like hysterectomies and myomectomies.
The MRI Imaging of Georgia is a medical center that now offers a non invasive outpatient treatment option for the ablatement or the breakdown of uterine fibroids. The procedure itself is performed with a Magnetic Resonance guided Focused Ultrasound device designed specifically for treating uterine fibroids. The procedure offers significant improvement in quality of life for patients as it preserves the uterus and the cervix. Menstrual bleeding and urinary dysfunction are also greatly improved.
Using a magnetic resonance (MR) scanner, the device enables the physician to determine the level of heating and further to track the progress of treatment both during and after the treatment. In addition it allows the doctor to distinguish between treated and untreated tissue and to recognize the three-dimensional boundaries of the fibroid itself and the surrounding organs with exact precision.
During the procedure, the ultrasound waves break the tumor down while the patient lies inside the scanner, which precisely targets the affected tissue. The heat of the ultrasound waves ablates the tumor and the process can be repeated as many times as is needed until the fibroid is completely broken down. As part of a natural process the patient’s body eliminates the unwanted tissue.
On average the treatment is found to last approximately 3-4 hours depending on the size of the tumor. Typically patients are able to return to normal activities within one to two days and report relief from symptoms within 3 months, depending on the size of the original tumor.
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The FDA approved new software that allows the ExAblate 2000 incisionless surgery procedure to be performed more efficiently by permitting more sonications during the same treatment window. This means that women with fibroids can be treated faster and women with larger fibroids may now be eligible for the outpatient procedure. The greater the area of the fibroid that a physician can treat, the greater the symptom relief. The agency is also allowing the system to be used with a more powerful open MRI machine, which means the physicians will have an even more precise view inside the woman’s body.
Background: Removing a woman’s uterus involves highly invasive surgery, hospitalization, weeks of recovery time and significant impact on her life by inducing menopause. The FDA approved the ExAblate 2000 incisionless surgery system in 2004. However, despite the completely non-invasive, outpatient treatment option, more than 200,000 women a year still undergo hysterectomies to find relief from their symptomatic uterine fibroids. Many women are not even made aware of the non-invasive treatment option from their doctors.
According to the U.S. National Institutes of Health, at least 25 percent of women suffer from uterine fibroids. These women may experience excessive bleeding, reproductive and sexual problems in addition to a heightened risk of anemia and a general decrease in their overall quality of life.
The ExAblate procedure is the only non-invasive treatment for symptomatic uterine fibroids approved by the Food and Drug Administration. Using MRI to see inside the woman’s body and plan the treatment, the physician aims focused ultrasound “sonications†at the tumor to burn it up. The procedure takes less than three hours, allows the patient to return home the same day and return to normal activities with her job and family within two days time.
For more information:
http://www.uterine-fibroids.org/
www.insightec.com
A full virtual press kit can be accessed through the following site: http://www.insightec.com/195-en-r10/VirtualPressCenter.aspx.
FDA Approves New Version of InSightec's ExAblate(R) 2000 That Speeds up Treatment Time; More Women now Eligible for the Only Incisionless Treatment Option for Symptomatic Uterine Fibroids
893 words
1 March 2007
08:45 AM
PR Newswire (U.S.)
English
Copyright © 2007 PR Newswire Association LLC. All Rights Reserved.
HAIFA, Israel, March 1 /PRNewswire/ -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved software that significantly speeds up the treatment time of the company's ExAblate(R) 2000 Magnetic Resonance guided Focused Ultrasound (MRgFUS) system, while ensuring the system's high level of safety and efficacy. Separately, the FDA also approved the ExAblate 2000 to be used with a 3.0 Tesla MRI scanner, in addition to the 1.5 Tesla.
"The newly-approved system allows the incisionless ExAblate procedure to be performed more efficiently than the conventional method and permits more sonications during the same treatment window," said George A. Holland, MD, director of MRI at the Lahey Clinic in Burlington, MA. in his abstract presented at the International Society for Magnetic Resonance in Medicine in May, 2006. "Using this technique, women with fibroids can be treated faster and women with larger fibroids may now be eligible for the outpatient procedure. The more of the fibroid that a physician can treat, the greater the symptom relief."
The new version, utilizes an "interleaved" mode of treatment whereby the system targets different parts of the fibroid, allowing the recently ablated tissue area to cool while the focus moves onto other areas of the fibroid. This reduces the cooling time required. Another new feature allows physicians to leverage the beam steering in phased array transducer to maximize the energy in the focal point, allowing significantly more volume to be treated for the same amount of energy applied.
The new system version includes improved safety features that help the physician identify anatomical details (such as bowels, bones, nerves, etc.) to help plan the treatment and minimize damage to non-targeted tissue.
The Lahey Clinic in Burlington, Mass., the University of California at San Diego (UCSD), Weill Cornell Medical Center in New York and KNI Imaging in Kalamazoo, Mich. participated in a 40-patient study to evaluate the new system version.
"We are pleased that the FDA has approved this new version that may enable physicians to treat greater amounts of fibroid in less time, helping to reduce symptoms and giving women with large fibroids access to this non-invasive treatment option," said Dr. Kobi Vortman, President and CEO of InSightec. "We continue to develop the ExAblate technology to ensure that physicians have the best tools to provide outstanding treatment to their patients."
The new system version was previously available in Europe and Asia.
ExAblate 2000 is the only MRgFUS system approved by the FDA (US Food and Drug Administration) as a non-invasive, outpatient procedure to treat uterine fibroids. Over 2,500 women have been treated worldwide for symptomatic uterine fibroids.
The company has begun clinical trials to study the technology's use in other indications including breast, bone, liver and brain tumors.
About ExAblate 2000
The ExAblate 2000 is the first U.S. Food and Drug Administration (FDA) approved system to use the breakthrough MRgFUS technology that combines MRI - to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome - and high intensity focused ultrasound to thermally ablate uterine fibroid tissue. MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. ExAblate received FDA approval for the treatment of symptomatic uterine fibroids in October 2004. ExAblate has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union's Information Society Technologies grand prize, The Wall Street Journal's 2004 Technology Innovation Awards, and Advanced Imaging's 2005 Solutions of the Year.
Uterine fibroids are benign growths in the uterus found in up to 70% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anemia, pain, pressure and often infertility. Existing treatment options include hysterectomy, myomectomy and uterine artery embolization and are invasive, involving hospitalization and several weeks of recovery time. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.
About InSightec
InSightec Ltd. is a privately held company owned by Elbit Medical Imaging (EMI), General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 135 employees and has invested more than $100 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/
Contact Information:
InSightec Ltd.
http://www.insightec.com/
Tel: +972-4-813-1313
Email: info@insightec.com
For media inquiries, contact:
Fern Lazar
Lazar Partners, Ltd.
Tel: +1-(212)-867-1762
Email: flazar@lazarpartners.com
SOURCE InSightec Ltd
Contact Information: InSightec Ltd., http://www.insightec.com/, Tel: +972-4-813-1313, Email: info@insightec.com. For media inquiries, contact: Fern Lazar, Lazar Partners, Ltd., Tel: +1-(212)-867-1762, Email: flazar@lazarpartners.com
FDA Approves use of InSightec's ExAblate(R) 2000 With GE Healthcare's 3 Tesla Magnetic Resonance Imaging System; Non-invasive Magnetic Resonance-guided Focused Ultrasound Uterine Fibroid Treatment Now Compatible With Both 1.5 Tesla and 3 Tesla Systems
696 words
1 March 2007
08:45 AM
PR Newswire (U.S.)
English
Copyright © 2007 PR Newswire Association LLC. All Rights Reserved.
HAIFA, Israel, March 1 /PRNewswire/ -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved use of the company's ExAblate(R) 2000 incisionless surgery system for uterine fibroids with GE Healthcare's 3 Tesla Magnetic Resonance Imaging systems, based on studies conducted at University of California at San Diego (UCSD), Weill Cornell Medical Center and KNI Imaging. ExAblate 2000, which combines Magnetic Resonance Imaging with focused ultrasound waves (MRgFUS) to non-invasively destroy tumors, was previously approved for use with the 1.5 Tesla magnet in 2004.
"This new approval allows physicians the freedom to use ExAblate with either a 1.5 Tesla or 3 Tesla MRI scanner, allowing busy MRI centers greater flexibility in scheduling use of their systems and allowing women greater access to this non-invasive procedure to destroy their symptomatic uterine fibroids," said William G. Bradley, Jr., M.D., Ph.D., F.A.C.R., Chairman of the University of California at San Diego's Department of Radiology and a Professor of Radiology at UCSD School of Medicine. "The 3 Tesla system also provides a higher level of anatomical detail."
ExAblate 2000 is the only MRgFUS system approved by the FDA as a non-invasive, outpatient procedure to treat symptomatic uterine fibroids and over 2,500 women with the condition have been treated worldwide.
The company has begun clinical trials to study the technology's use in many oncology-based indications including breast, bone, liver and brain tumors.
About ExAblate 2000
The ExAblate 2000 is the first U.S. Food and Drug Administration (FDA) approved system to use the breakthrough MRgFUS technology that combines MRI - to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome - and high intensity focused ultrasound to thermally ablate uterine fibroid tissue. Real time MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment to ensure that the targeted tumor is fully treated and surrounding tissue is spared. ExAblate received FDA approval for the treatment of symptomatic uterine fibroids in October 2004. ExAblate has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union's Information Society Technologies grand prize, The Wall Street Journal's 2004 Technology Innovation Awards, and Advanced Imaging's 2005 Solutions of the Year.
Uterine fibroids are benign growths in the uterus appearing in up to 70% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anemia, pain, pressure and often infertility. Existing treatment options include hysterectomy, myomectomy which are invasive, involving hospitalization and several weeks of recovery time and uterine artery embolization that is minimally invasive requiring hospitalization and one to two weeks recovery. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.
About InSightec
InSightec Ltd. is a privately held company owned by Elbit Medical Imaging (EMI), General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 135 employees and has invested more than $100 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/
Contact Information
InSightec Ltd.
http://www.insightec.com/
Tel: +972-4-813-1313
Email: info@insightec.com
For media inquiries, contact:
Fern Lazar
Lazar Partners, Ltd.
Tel: +1-(212)-867-1762
Email: flazar@lazarpartners.com
SOURCE InSightec Ltd
Contact Information, InSightec Ltd., http://www.insightec.com/, Tel: +972-4-813-1313, Email: info@insightec.com, For media inquiries, contact: Fern Lazar, Lazar Partners, Ltd., Tel: +1-(212)-867-1762, Email: flazar@lazarpartners.com
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