First Non-invasive Technology For Treatment Of Uterine Fibroids Awarded Mhlw Approval In Japan

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14th January 2010, 09:28am - Views: 837

Culture International InSightec Ltd 2 image


First Non-Invasive Technology for Treatment of Uterine Fibroids Awarded MHLW Approval

in Japan

TIRAT CARMEL, Jan. 13 /PRNewswire-AsiaNet/ --


    - InSightec's ExAblate System Uses Magnetic Resonance-Guided Focused

Ultrasound to Perform Uterine Procedures Without Incisions


    InSightec Ltd. announced today that Japan's Ministry of Health, Labor and Welfare

(MHLW) has approved the company's ExAblate® MR-guided Focused Ultrasound (MRgFUS)

system for the treatment of women with uterine fibroids.

    "We are  very pleased that the Japanese Ministry of Health has approved the

ExAblate system and that women in Japan will now have access to a noninvasive

treatment option for uterine fibroids," said Dr. Kobi Vortman, President and Chief

Executive Officer of InSightec. "The approval was based on a growing body of evidence

showing that ExAblate is a safe, effective, and durable treatment for this

widespread, life-impacting condition. ExAblate is an outpatient procedure and

patients normally return home the same day and to work within one to two days

compared to lengthy hospitalizations and recovery times associated with more invasive

procedures such as hysterectomy, myomectomy or UAE."

    ExAblate is currently the only noninvasive treatment for uterine fibroids

approved for use in Japan. Approximately 25% Japanese women will develop symptomatic

uterine fibroids, primarily during childbearing years. These benign tumors can

significantly impair functionality and degrade quality of life resulting in

significant work absences.  

    Using the ExAblate system, the physician uses the Magnetic

Resonance Imaging (MRI) to visualize the patient's anatomy and then aims

focused ultrasound waves at the targeted tissue to thermally ablate, or

destroy it. The MRI allows the physician to monitor and continuously adjust

the treatment in real time. The patient is consciously sedated to alleviate

pain and minimize motion.

    A growing body of evidence supports the system's safety and

efficacy, including the results of a study published in the August 2007

edition of Obstetrics and Gynecology. The study showed that ExAblate offered

women sustained relief from uterine fibroid symptoms for up to two years,

with a low incidence of side effects. The 359-patient Mayo Clinic-led

collaborative study also showed that destroying as much of the fibroid as

possible leads to the most durable symptom relief with 85% of the

participants experiencing symptom improvement after one year. Studies

conducted in Japan indicate similar results.

    The ExAblate system received the CE Mark for uterine fibroids in October 2002 and

US Food and Drug Administration (FDA) approval in 2004. Over 5,500 women around the

world have chosen to undergo the non-invasive ExAblate treatment for their

symptomatic uterine fibroids over invasive surgery. 

    GE Healthcare is the distributor of ExAblate in Japan.

    About InSightec

Culture International InSightec Ltd 3 image

    InSightec Ltd. is a privately held company owned by Elbit Imaging, 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 160

employees and has invested more than $130 million in research, development, and

clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more


    About GE Healthcare Japan

    GE Healthcare Japan Corporation provides cutting edge medical technologies and

healthcare services that design the next-generation patient care model by utilizing

its expertise across a wide range of areas such as medical diagnostic imaging systems

and healthcare IT equipments such as CT (Computerized Tomography) systems and MR

(Magnetic Resonance) imaging systems, medical diagnostic drugs, biological

information monitors, drug discovery, biotechnology-based drugs, and providing

support for the management of healthcare institutes.  GE Healthcare Japan Corporation

was established as the core site in Japan for the healthcare business section within

the General Electric Company (GE, based in the U.S.) 


    Media Contact:

    Hollister Hovey

    Lazar Partners


    SOURCE: InSightec Ltd

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