An MR-guided focused ultrasound ablation system may be the first of its kind to be approved for marketing in the U.S. The nod could come as early as October.
The FDA's Obstetrics and Gynecology Devices Panel in June recommended approval for the ExAblate system, which provides noninvasive treatment for uterine fibroids.
The government said it will release ExAblate for marketing as soon as the manufacturer, Israel-based InSightec, completes postapproval conditions related to training material and proper labeling. The FDA could announce approval by Oct. 1, said Rob Newman, vice president of InSightec North America, based in Dallas.
The panel's recommendation for approval is based on results of an international multicenter clinical trial involving 55 women with uterine leiomyomas. Researchers concluded the MR-guided focused ultrasound interventional procedure was effective and well tolerated (Am J Obstet Gynecol 2003;189:48-54). The National Institutes of Health and InSightec financed the study.
Most fibroid treatments involve some kind of surgical or interventional treatment. Even uterine artery embolization requires overnight hospitalization, produces a significant amount of pain, and requires at least one incision to place the catheter.
Focused ultrasound ablation overcomes these disadvantages, said principal investigator Dr. Elizabeth A. Stewart, clinical director of the Center for Uterine Fibroids at Brigham and Women's Hospital.
The focused ultrasound system does not require surgical incisions, and the procedure is performed on an outpatient basis. Patients treated in clinical trials have reported minimal pain after ablation, and most do not need pain medication, Stewart said.
The MR guidance helps visualize both the fibroid and the surrounding structures, monitor the appropriate temperature required to cause tissue coagulation, and control ablation to avoid the destruction of normal tissue.
Uterine fibroids are one of the most common reasons for surgery among women of reproductive age. The current standard of care for the condition includes hysterectomy, myomectomy, uterine artery embolization, and drug therapy. Until now, however, many women chose not to undergo any kind of treatment, because of the economic implications.
Being out of work could be far more costly than therapy. Hysterectomy usually requires about six weeks' recovery, and uterine artery embolization seven to 10 days. Patients in the focused ultrasound ablation study, however, were out of work less than two days, Stewart said.
"If women had a good option that didn't take them away from work and their families for a substantial period of time, they would definitely seek treatment," she said.
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