FDA Approves New Ultrasound Device to Treat Uterine Fibroids

A new device to treat uterine fibroids -- fibrous clumps that can cause miscarriages, painful menstruation and other related problems in women -- won U.S. regulatory approval Friday.

The system, developed by InSightec, a unit of Israel-based Elbit Medical Imaging, uses ultrasound waves to break up the clumps and could be an alternative to the removal of a uterus, or hysterectomy.

Food and Drug Administration officials said the device, called the ExAblate 2000 System, was not intended for women who wanted to get pregnant in the future.

About 80% of women suffer from uterine fibroids at some point in life, according to the National Institutes of Health. Symptoms include pain, bleeding and uterine swelling, but some women have no symptoms.

Up to 25% will eventually require a hysterectomy.

The new device “hopefully will offer people a ... significant, alternative approach to [the] treatment of fibroids which is completely noninvasive,” said Dr. Clare Tempany, a radiologist at Brigham and Women’s Hospital in Boston who helped conduct company-funded trials of the procedure.

The ExAblate uses magnetic resonance imaging, or MRI, to pinpoint the noncancerous tumors. Heat from ultrasound waves is then used to kill the fibroid tissue, which is flushed from the body naturally.

GE Healthcare, a unit of General Electric Co., said it was collaborating with InSightec to deliver the ExAblate system, which works with GE’s Signa magnetic resonance system.

The FDA is requiring InSightec to study the device for three years to evaluate long-term safety and effectiveness.

InSightec President and Chief Operating Officer Dr. Jacob Vortman said his company also is investigating possible use of the device to treat breast, liver, bone and brain cancers.

“Today’s approval ... underscores the importance of imaging technologies not only as diagnostic tools, but also as therapeutic treatment,” Vortman said.