First Non-Invasive Technology for Treatment of Uterine Fibroids Awarded MHLW Approval in Japan
By Insightec Ltd, PRNETuesday, January 12, 2010
InSightec's ExAblate System Uses Magnetic Resonance-guided Focused Ultrasound to Perform Uterine Procedures Without Incisions
TIRAT CARMEL, Israel, January 13 - InSightec Ltd. announced today that Japan's Ministry of
Health, Labor and Welfare (MHLW) has approved the company's ExAblate(R)
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 approval holder and 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
information, please go to: www.insightec.com/
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.).
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Media Contact: Hollister Hovey, Lazar Partners, +1-646-871-8482, hhovey at lazarpartners.com
Tags: InSightec Ltd, Israel, Mri, Tirat carmel