HAIFA, Israel, June 22 /PRNewswire/ -- InSightec announced today that
five sites in the US are enrolling African American women in a post-marketing
study to evaluate the efficacy of its ExAblate 2000 in treating uterine
fibroids. This study is an element of the FDA's commercial approval for
ExAblate in October 2004.
Uterine fibroids are benign tumors that develop in the uterus. They can
be as small as a pea or as large as a grapefruit and often cause heavy and
extensive menstrual bleeding, pain or discomfort in the pelvis, pressure on
the lower abdomen, and frequent urination, among other symptoms.
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 is to
confirm the efficacy of the ExAblate treatment in African American women as
they tend to have more severe uterine fibroids.
The study is open to African-American women who have symptomatic uterine
fibroids, have completed their families and are not contraindicated for
magnetic resonance imaging (MRI). Additional inclusion/exclusion criteria
apply. The study includes a 36-month follow-up to evaluate long-term efficacy
of the treatment.
About the ExAblate(R) 2000 procedure
ExAblate is the first system to use the breakthrough MRgFUS technology
which combines MRI -- to visualize tissues in the body, plan the treatment
and monitor in real time treatment outcome -- and high intensity ultrasound
to thermally ablate tissue. 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 other tissue is avoided. The
ExAblate 2000 is only compatible with GE Healthcare's Signa MR systems.
The five major medical centers in the United States that will be
conducting this follow- study for the non-invasive treatment of uterine
fibroids among African American women are:
- Beverly Tower Wilshire Advanced Imaging Center - Radnet in
Beverly Hills, CA
- North Texas Uterine Fibroid Institute in Dallas, TX
- University MRI in Boca Raton, FL
- The Lahey Clinic in Burlington, MA
- Brigham and Women's Hospital in Boston, MA
- Virtua Health in Voorhees, NJ
For more information about the trial and the facilities performing the
procedure, please visit www.insightec.com or call +1-(866)-EXABLATE or the
InSightec Image Guided Treatment Ltd. is a privately held company owned
by Elbit Medical Imaging (EMI), General Electric, private investors 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 100
employees and has invested more than $80 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/
For media inquiries, contact:
Lazar Partners, Ltd.
For more information about uterine fibroids, please visit
SOURCE Insightec Ltd.