Health Technology Brief

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Magnetic Resonance-Guided Focused Ultrasound Therapy (ExAblate 2000; InSightec Ltd.) for Ablation of Uterine Fibroids

August 22, 2019

Health Problem: Uterine fibroids (UFs) (also called leiomyomata or myomas) are benign tumors of the myometrium, the smooth muscle layer of the uterus. Approximately 25% of fibroids are symptomatic. Fibroids are the most common indication for hysterectomy in many countries.

Technology Description: Magnetic resonance-guided focused ultrasound (MRgFUS) combines thermal effects (due to absorption of acoustic energy) with magnetic resonance imaging (MRI) guidance to treat symptomatic UF. Thermal ablation by MRgFUS causes cell death and coagulative necrosis of the targeted tissue while sparing surrounding organs.

Controversy: Controversies pertinent to the evaluation of treatments for symptomatic UF include whether there is a strong correlation between reductions in fibroid volume as well as symptom relief. In addition, the efficacy and safety of MRgFUS in comparison with other clinical alternatives, particularly other uterine-sparing technologies such as uterine artery embolization and radiofrequency ablation, are unresolved. Pertinent to the noninvasive MRgFUS treatment of UF is whether this treatment is effective and safe for women who wish to reduce symptoms related to UF yet wish to maintain fertility compared with minimally invasive procedures or surgical procedures. Patient selection, including patient and fibroid characteristics, the inclusion of adequate numbers of African American women in clinical trials, whether treatments achieve long-term symptom relief, and cost-effectiveness of various treatments are additional factors that have not been investigated adequately in the various treatment approaches of symptomatic UF.

Key Questions:

  • Is MRgFUS effective in treating symptomatic UF?
  • How does MRgFUS compare with alternative procedures for treatment of symptomatic UF?
  • Is MRgFUS technology safe?
  • Have definitive patient selection criteria been identified for MRgFUS for the treatment of symptomatic UF?