MEDIA RELEASE PR37811
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
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
+1-646-871-8482
hhovey@lazarpartners.com
SOURCE: InSightec Ltd
NEWS 
