A device that treats fibroids through a combination of ultrasound and magnetic resonance imaging won approval Friday from the Food and Drug Administration.
Fibroids are non-cancerous masses that occur in the uterus that can affect between 20 percent and 40 percent of women over 35. Some have no symptoms, but others experience heavy and prolonged menstrual periods, pain in the back, legs or pelvis, pressure on the bladder or bowels and pain during sexual intercourse.
The FDA said it gave expedited approval to ExAblate because it offers major advantages over other treatments for fibroids.
The device is intended for use on women who have completed childbearing or don’t plan to have children, the FDA said.
ExAblate combines a magnetic resonance imaging machine to locate and observe the fibroids and to keep track of the temperature of the uterine tissue, with a focused ultrasound beam that heats and destroys the fibroid tissue using high frequency, high-energy sound waves.
The FDA said this is the first time these two systems have been combined and the first time MRI 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 and the procedure can last as long as three hours, FDA said.
Not for use on all fibroids
The machine cannot be used on all fibroids. Those close to sensitive organs such as the bowel or bladder and those outside the image area cannot be treated.
Current treatment for uterine fibroids includes hormone therapy, surgical removal of the fibroids while leaving the uterus intact, or by hysterectomy.
ExAblate provides a uterine-sparing alternative for these women and is a non-invasive treatment.
The manufacturer, InSightec, Ltd., of Israel, studied use of the ExAblate System to treat 109 women with uterine fibroids at seven medical centers around the world. When the ExAblate-treated women were followed up six months later, the study showed that the new device had successfully reduced fibroid-related problems in 71 percent.
However, 21 percent of the patients needed an alternative surgical treatment for fibroids within a year.
FDA said that the treatment should not be used by women planning to have children because it could alter the composition and strength of the uterine tissue, and the effects of the treatment on the ability to become pregnant and carry a fetus to term or on the development of the fetus have not been determined.