HAIFA, Israel, March 21 /PRNewswire/ -- InSightec announced today that
the company has completed treatment of the final patient in a post-marketing
study to evaluate the efficacy of its ExAblate 2000 in treating uterine
fibroids in African-American women. This study is an element of the FDA's
commercial approval for ExAblate in October 2004.
According to the U.S. National Institutes of Health, at least 25 percent
of women, or thirteen million women in U.S., aged 25-50, suffer from uterine
fibroids and African-American women are three to five times more likely to
develop the tumors than their Caucasian counterparts. This study was
initiated to confirm the efficacy of the ExAblate 2000 treatment in African
American women, as they tend to have more severe uterine fibroids.
Following an expedited Pre-Market Approval (PMA) review, the U.S. Food
and Drug Administration in October 2004 approved ExAblate 2000 for commercial
use in patients with uterine fibroids. As part of the PMA approval order,
InSightec reports safety and efficacy results to the FDA on each of the
ongoing clinical studies every six months. The ExAblate 2000 is being used in
30 sites worldwide and has treated over 1500 women with uterine fibroids.
In addition to the 30 African-American patients treated in the
pre-approval study 75 patients were treated in this post-PMA approval study
focused on African-American women, and will be followed up for a period of 36
months. This study, tailored to the African American population, will produce
some of the first data of its kind regarding the non-invasive treatment
management of uterine fibroids of this high risk segment of population with
the ExAblate system.
"ExAblate 2000 has given women a new non-invasive, outpatient treatment
option for a condition that previously required invasive surgery and long
recovery times," Dr. Phyllis Gee, an Ob/GYN surgeon at the Dallas site who is
participating in the study said. "Additional studies and data will hopefully
continue to add to our body of knowledge about this revolutionary treatment
A total of six sites participated in this study: Brigham and Women's
Hospital, Boston, Mass.; Virtua Health Hospital, Vorhees, NJ; University MRI,
Boca Raton, Florida; Beverly Tower Wilshire Advanced Imaging Center Radnet
Radiology , Los Angeles, Ca.; Lahey Clinic, Burlington, MA, Tx and ExAblate
of Dallas, Plano, Tx.
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
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 EU's Information Society
Technologies grand prize for 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 that affect
approximately 13 million women of childbearing age in the U.S. Each year
approximately 200,000 women have hysterectomies, to treat uterine fibroids,
requiring several days of hospitalization and extensive recovery time. The
ExAblate 2000 is a non-invasive, outpatient procedure using MR-guided focused
ultrasound to thermally ablate (destroy) tumors in the uterus. For women this
means no hospital stay and only 1-2 days of recovery as opposed to the one
week (UAE); two weeks (myomectomy); or six weeks (hysterectomy) usually
associated with treatment of this condition.
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SOURCE InSightec Ltd.