Focused ultrasound: FDA panel gives nod to fibroid Tx.(News)

GAITHERSBURG, MD. -- A Food and Drug Administration advisory panel last month recommended, with conditions, the approval of a system that ablates uterine fibroids using focused ultrasound under the guidance of magnetic resonance.

If approved, the system would be the first noninvasive therapy for symptomatic fibroids available in the United States.

The technology, known as magnetic resonance-guided focused ultrasound (MRgFUS), induces coagulative necrosis of fibroids through thermoablation. The treatment is intended for premenopausal or perimenopausal patients who have finished childbearing.

Eighty percent of 109 women treated with the system demonstrated significant improvement at a 6-month follow-up in a randomized phase III trial, Dr. Elizabeth A. Stewart said earlier in the year at the annual meeting of the American College of Obstetricians and Gynecologists in Philadelphia.

"This technology is well tolerated and will likely allow many women who previously rejected all of the current treatments to get treatment for their disease," said Dr. Stewart, who is a consultant to In-Sightec Inc., Dallas, which markets the MRgFUS system, known as ExAblate 2000.

The average procedure takes 90-120 minutes and is performed on an outpatient basis; some women may require an overnight stay. It's recommended that the patient be placed under conscious sedation.

The obstetrics and gynecology devices panel of the FDA's Medical Devices Advisory Committee voted 8-5 in favor of recommending the ExAblate 2000 system.