FDA Clears ExAblate Fertility Enhancement Study in Women With Uterin... (deliver babies after undergoing ExAblate...)

FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids

Date:5/28/2008

deliver babies after undergoing ExAblate treatment for their uterine fibroids. To date, 17 women delivered healthy infants at term without complications and with an average of seven and a half pounds birth weight. Ten women delivered vaginally and seven delivered by caesarean section. No treatment-related adverse events were reported in those earlier cases.

"As women have children later in their lives, the number of women having pregnancies and uterine fibroids is significant and growing," said Haywood L. Brown, MD, Professor of Obstetrics and Gynecology and chair of the Department of Obstetrics and Gynecology at Duke University Medical Center. "An evidence-based review concluded that if fibroids distort the uterine cavity, there is evidence in favor of removing them to increase pregnancy rates and decrease the rate of miscarriage. Unfortunately, since fibroids that have grown on the wall of the uterus need to be removed by myomectomy, a major abdominal procedure, the morbidity of the intervention may outweigh the benefits of removing the fibroids."

According to Gautam Chaudhuri, MD, Professor of Obstetrics and Gynecology and Chair of the Department of Obstetrics and Gynecology at the University of California, Los Angeles (UCLA) Medical Center, "In a small number of cases, a myomectomy will later require a hysterectomy. In less grave instances, myomectomy carries a risk of post operative adhesions, which may impair a woman's fertility and take time away from trying to become pregnant while she undergoes the procedure and lets her uterus heal. A non-invasive treatment could be a great benefit to women whose fertility issues may be caused by fibroids."

"We're pleased that the FDA has cleared us to start this important study that could potentially impact thousands of women who are struggling to conceive," said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. "We remain highly committed to moving the treatment paradigm away fro
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