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

TIRAT CARMEL, Israel, May 28 /PRNewswire/ --

- Study Will Compare Birth Rates of Women who Underwent Non-Invasive MRgFUS to Those who had Invasive Fibroid Surgery

InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) cleared the company to conduct a clinical trial to evaluate the efficacy and safety of the ExAblate(R) 2000 system utilizing MR-guided Focused Ultrasound Surgery (MRgFUS) for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility.

Twenty U.S. and international sites will enroll a total of 650 women with uterine fibroids who are diagnosed with unexplained infertility. Half the women will undergo treatment with the ExAblate system, while the other half will have their fibroids surgically removed.

The study will measure the safety of each procedure, including pregnancy and delivery-related complications. The main efficacy goal of the trial will be to measure which procedure leads to a higher percentage of healthy live births resulting from pregnancies three to 15 months after treatment. Researchers will also examine the cost of treatment and any additional clinically required medical encounters and/or medications outside the study visits.

"While the link between uterine fibroids and infertility isn't fully understood, many women with uterine fibroids and infertility give birth to healthy babies after having their fibroids surgically removed," said Elizabeth A. Stewart, MD, a reproductive endocrinologist and Professor of Obstetrics and Gynecology at Mayo Clinic in Rochester, Minnesota. "The non-invasive ExAblate system precisely targets fibroid tissue without causing damage to the surrounding healthy areas, suggesting that it may be a safe approach for women with fibroids who want to preserve their fertility."

Accumulating clinical evidence shows that women have been able to conceive and successfully
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SOURCE InSightec Ltd
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