The U.S. Food and Drug Administration (FDA) today approved the ExAblate 2000 System, a new medical device that uses magnetic resonance image guided focused ultrasound to target and destroy uterine fibroids, non-cancerous masses located in the uterus.
The device is intended to treat women who have completed child bearing or do not intend to become pregnant.
FDA expedited review of the device because it offers significant advantages over existing treatments for uterine fibroids.
ExAblate combines two systems--a magnetic resonance imaging (MRI) machine to visualize patient anatomy, map the volume of fibroid tissue to be treated, and monitor the temperature of the uterine tissue after heating, and a focused ultrasound beam that heats and destroys the fibroid tissue using high frequency, high-energy sound waves. This is the first time these two systems have been combined and the first time MR has been used to monitor tissue temperature.
The treatment requires repeated targeting and heating of fibroid tissue while the patient lies inside the MRI machine. The procedure can last as long as three hours.
The new device can be used to treat some--but not all--fibroids. Fibroids close to sensitive organs such as the bowel or bladder and those outside the image area cannot be treated.
Approximately 20 percent to 40 percent of women 35 and older have fibroids. Although many of these women do not experience any symptoms, in others the location and size of fibroids can cause heavy and prolonged menstrual periods, pain in the back, legs or pelvis, pressure on the bladder or bowels, and pain during sexual intercourse.
Women who experience problems from uterine fibroids are currently treated with hormone therapy, myomectomy (removal of the fibroids while leaving the uterus intact), or by hysterectomy (removal of the uterus). ExAblate provides a uterine-sparing alternative for these women that is a non-invasive treatment.
FDA approved the system based on a review of clinical studies of safety and effectiveness conducted by the manufacturer and on the recommendation of a panel of outside experts convened by the agency to review the device.