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FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
Date:5/28/2008

m invasive surgeries. To date, over 4,000 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery. Should this trial confirm our expectations, more women will be able to choose a non-invasive treatment."

In October 2007, the European designated Notified Body changed the CE Mark to enable European women with uterine fibroids who may want to become pregnant to consider MRgFUS as a treatment option with their physicians. This change was made based on accumulating data from studies demonstrating that women safely gave birth after undergoing MRgFUS treatment. The ExAblate system received the CE Mark for uterine fibroids in October 2002 and the FDA approved the system as a treatment for symptomatic uterine fibroids in 2004 for patients who had finished their family planning.

About Uterine Fibroids

Uterine fibroids are benign growths in the uterus that affect more than 30% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anaemia, pain, pressure and often infertility. Existing treatment options include hysterectomy, myomectomy and uterine artery embolization that are invasive and minimally invasive, involving hospitalization and several weeks of recovery time. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.

About ExAblate

ExAblate is the first system to use the breakthrough MRgFUS technology that combines MRI - to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time - and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, 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. Approved by the U.S. Food and Drug Admin
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