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ROCKVILLE, D.C., Oct 22, 2004 (United Press International via COMTEX) -- The U.S. Food and Drug Administration Friday approved a new device that uses magnetic resonance imaging to help find and destroy uterine fibroids.
The ExAblate 2000 System was developed by InSightec Ltd. of Israel. It uses MRI-guided ultrasound to map out the non-cancerous masses in the uterus and a focused heat beam to eliminate them.
The treatment is done while a patient lies inside the MRI machine and is intended for women who are beyond childbearing years or who do not intend to become pregnant.
FDA gave the device an expedited review because clinical studies showed it offered significant advantages over existing fibroid treatments, including hormones, surgical removal of the fibroids and hysterectomy.
Some 20 percent to 40 percent of women ages 35 and older have fibroids. While many women have no symptoms, some have heavy menstrual periods, back, leg or pelvis pain, pressure on the bladder or bowels, and pain during sexual intercourse.
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Page last updated: 05 November 2004 |