Four years ago, Betsy W. suffered extensive bleeding from uterine fibroids. Betsy, now 45, an interior decorator in Charlottesville, Va., rejected a hysterectomy or hormone treatment because she wanted to avoid early menopause and retain the ability to have children. So she opted for a new experimental therapy.
That therapy, called magnetic resonance-guided focused ultrasound or simply focused ultrasound, uses high-intensity ultrasound beams to destroy uterine fibroids. Betsy, who asked that her last name not be used, entered a non-randomized trial at the University of Virginia Medical Center to evaluate the new treatment. She didn't want a trial in which she could be randomly assigned to a placebo group. “I wanted to be treated, not to further science,” she said.
The technique combines an MRI machine with an ExAblate ultrasound unit, manufactured by Israel-based InSightec. The ExAblate costs about $1 million, and the device's extended service contract costs about $75,000 a year, according to ECRI Institute, a not-for-profit based in Plymouth Meeting, Pa., that evaluates new medical technologies. According to ECRI, per-procedure costs for ExAblate treatment of uterine fibroids are $10,000 to $25,000. Betsy's insurance paid for only a diagnostic test. The University of Virginia clinical trial picked up the rest of the cost.
The Food and Drug Administration approved marketing of the ExAblate to treat uterine fibroids in 2004. In 2012, it approved the device for treating metastatic bone cancer pain. While bone cancer pain can be eased in about two-thirds of patients through chemotherapy, hormone therapy, radiopharmaceuticals, bisphosphonates and pain medication, these treatments are not effective in the remaining third, so new treatment options have been sought. In other countries, focused ultrasound is used for dozens of other applications, including facet joint arthritis, adenomyosis, essential tremor and Parkinson's disease.