FDA approves label change for non-invasive fibroid treatment

InSightec Ltd. has announced that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids.

Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue.

"In allowing doctors to destroy the entire fibroid, we believe the FDA has demonstrated further confidence in the safety and efficacy of the non-invasive ExAblate system," said Haywood L. Brown, MD, Chair of Obstetrics and Gynecology/Maternal-Fetal Medicine at Duke Medicine in Durham, North Carolina.

The FDA label change was based on a growing body of evidence supporting the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology demonstrating that patients experience longer and improved symptom reduction as a greater volume of the fibroid is destroyed.

"We're extremely pleased that the FDA approved this important label change and believe this underscores the safety of our system, the only non-invasive treatment for uterine fibroids available today," said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. "We remain committed to continuously expanding our treatment indications and applications through research. An ongoing research study is evaluating the potential of treating fibroids with the ExAblate system to enhance fertility when other potential causes of women's infertility have been ruled out. The study will compare birth rates of women who underwent ExAblate treatment to those who had a surgical myomectomy."

"Evidence supports removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage," Dr. Brown added. This trial tests the premise in women who have not been eligible for minimally invasive treatment.

The Fertility Enhancement study is being conducted at the Mayo Clinic in Rochester, Minnesota; Duke University in Durham, North Carolina; Willowbend Health and Wellness in Plano, Texas; and Focused Ultrasound Northwest in Renton, Washington. For more information on the study please visit http://www.clinicaltrials.gov/

To date, InSightec has reported 54 pregnancies, 22 deliveries with 11 ongoing pregnancies with women who previously underwent the ExAblate procedure.