Focused ultrasound treatment for uterine fibroids has been available to women in the U.S. since a treatment system was approved by the Food and Drug Administration (FDA) in 2004.

FDA Approved squareFocused ultrasound is a non-invasive way to treat uterine fibroids. Using this treatment method in conjunction with image guidance, the physician directs a focused beam of energy through the patient’s skin, superficial fat layer, and abdominal muscles to heat and destroy the fibroid tissue without damaging nearby tissue or the tissues that the beam passes through on its way to the target.

The treatment is conducted with the patient awake and uses either magnetic resonance (MR) or ultrasound (US) guidance. This enables the 

physician to target, control, and monitor the treatment in real time.

Advantages

  • Outside Approval SquareIt is a noninvasive treatment with a short recovery time and a quick return to work and activities of normal life (usually the next day).
  • It offers rapid and durable resolution of fibroid symptoms (sometimes within days of treatment).
  • It has a low rate of complications.
  • It preserves fertility with published studies reporting that women are able to conceive and have normal pregnancies after treatment.

Get Treated

Clinical Trials Square

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Regulatory Approval and Reimbursement

In 2004, MRI-guided focused ultrasound was approved by US Food and Drug Administration for the treatment of uterine fibroids. Currently, no major U.S. insurance company provides consistent coverage and reimbursement for focused ultrasound treatment of fibroids. However, Blue Cross/Blue Shield, AETNA, and United have all approved cases on an individual basis.

Internationally, focused ultrasound is approved in Canada, China, Europe, India, Japan, Korea, the Middle East, Oceania, Russia, South America, and Taiwan. 

In the United Kingdom, Germany, and Russia, individual patients have gained local level approval. In China, healthcare insurance partially or fully covers the cost of the treatment. 

In Israel, Clalit Medical Insurance is covering MRgFUS for symptomatic uterine fibroids.

Notable Papers

Wang Y, Liu X, Wang W, Tang J, Song L. Long-term Clinical Outcomes of US-Guided High-Intensity Focused Ultrasound Ablation for Symptomatic Submucosal Fibroids: A Retrospective Comparison with Uterus-Sparing Surgery. Acad Radiol. 2020 Jun 8:S1076-6332(20)30286-5. doi: 10.1016/j.acra.2020.05.010.

Wu G, Li R, He M, Pu Y, Wang J, Chen J, Qi H. A comparison of the pregnancy outcomes between ultrasound-guided high-intensity focused ultrasound ablation and laparoscopic myomectomy for uterine fibroids: a comparative study. Int J Hyperthermia. 2020;37(1):617-623. doi: 10.1080/02656736.2020.1774081.

Ning G, Zhang X, Zhang Q, Wang Z, Liao H. Real-time and multimodality image-guided intelligent HIFU therapy for uterine fibroid. Theranostics. 2020 Mar 26;10(10):4676-4693. doi: 10.7150/thno.42830. eCollection 2020.

Liu X, Tang J, Luo Y, Wang Y, Song L, Wang W. Comparison of high-intensity focused ultrasound ablation and secondary myomectomy for recurrent symptomatic uterine fibroids following myomectomy: A retrospective study. BJOG. 2020 Apr 13. doi: 10.1111/1471-0528.16262.

Verpalen IM, Anneveldt KJ, Vos PC, Edens MA, Heijman E, Nijholt IM, Dijkstra JR, Schutte JM, Franx A, Bartels LW, Moonen CTW, Boomsma MF. Use of multiparametric MRI to characterize uterine fibroid tissue types. MAGMA. 2020 Mar 26. doi: 10.1007/s10334-020-00841-9.

Keserci B, Duc NM, Nadarajan C, Huy HQ, Saizan A, Ahmed WAW, Osman K, Abdullah MS. Volumetric MRI-guided, high-intensity focused ultrasound ablation of uterine leiomyomas: ASEAN preliminary experience. Diagn Interv Radiol. 2020 Mar 25. doi: 10.5152/dir.2019.19157.

Huang YF, Deng J, Wei XL, Sun X, Xue M, Zhu XG, Deng XL. A comparison of reproductive outcomes of patients with adenomyosis and infertility treated with High-Intensity focused ultrasound and laparoscopic excision. Int J Hyperthermia. 2020;37(1):301-307. doi: 10.1080/02656736.2020.1742390.

Verpalen IM, de Boer JP, Linstra M, Pol RLI, Nijholt IM, Moonen CTW, Bartels LW, Franx A, Boomsma MF, Braat MNG. The Focused Ultrasound Myoma Outcome Study (FUMOS); a retrospective cohort study on long-term outcomes of MR-HIFU therapy. Eur Radiol. 2020 Feb 10. doi: 10.1007/s00330-019-06641-7.

Ning G, Zhang X, Liao H. Morphological active contour without edge-based model for real-time and non-rigid uterine fibroid tracking in HIFU treatment. Healthc Technol Lett. 2019 Nov 26;6(6):172-175. doi: 10.1049/htl.2019.0067. eCollection 2019 Dec.

Zhang YJ, Xiao ZB, Lv FR, Sheng B, Li J, Zheng YN, Lv FJ, Chen JY. MRI evaluation of endopelvic fascial swelling and analysis of influencing factors in patients with uterine fibroids after high-intensity focused ultrasound ablation. Int J Hyperthermia. 2020;37(1):175-181. doi: 10.1080/02656736.2019.1701100.

Li C, Jin C, Liang T, Li X, Wang R, Zhang Y, Yang J. Magnetic resonance-guided high-intensity focused ultrasound of uterine fibroids: whole-tumor quantitative perfusion for prediction of immediate ablation response. Acta Radiol. 2019 Nov 28:284185119891692. doi: 10.1177/0284185119891692.

Liao D, Xiao Z, Lv F, Chen J, Qiu L. Non-contrast enhanced MRI for assessment of uterine fibroids' early response to ultrasound-guided high-intensity focused ultrasound thermal ablation. Eur J Radiol. 2019 Nov 10;122:108670. doi: 10.1016/j.ejrad.2019.108670.

Liao WL, Ying TH, Shen HP, Wu PJ. Combined treatment for big submucosal myoma with High Intensity Focused Ultrasound and hysteroscopic resection. Taiwan J Obstet Gynecol. 2019 Nov;58(6):888-890. doi: 10.1016/j.tjog.2019.04.001.

Nguyen MD. Magnetic Resonance-Guided Focused Ultrasound Surgery for Leiomyoma and Adenomyosis: An Alternative Nonvascular Approach. Gynecol Minim Invasive Ther. 2019 Oct 24;8(4):196-198. doi: 10.4103/GMIT.GMIT_19_19. eCollection 2019 Oct-Dec.

Sinha V, Mehta S, Kalantzis G, Steinberg F, LeBlang SD. Artifact from myomectomy/C-Section on MRI images - what does this mean for MR-guided focused ultrasound candidacy for uterine fibroids? Int J Hyperthermia. 2019;36(1):1079-1083. doi: 10.1080/02656736.2019.1682689.

Lee JY, Chung HH, Kang SY, Park EJ, Park DH, Son K, Han JK. Portable ultrasound-guided high-intensity focused ultrasound with functions for safe and rapid ablation: prospective clinical trial for uterine fibroids-short-term and long-term results. Eur Radiol. 2019 Nov 8. doi: 10.1007/s00330-019-06468-2.

Verpalen IM, Anneveldt KJ, Nijholt IM, Schutte JM, Dijkstra JR, Franx A, Bartels LW, Moonen CTW, Edens MA, Boomsma MF. Magnetic resonance-high intensity focused ultrasound (MR-HIFU) therapy of symptomatic uterine fibroids with unrestrictive treatment protocols: A systematic review and meta-analysis. Eur J Radiol. 2019 Nov;120:108700. doi: 10.1016/j.ejrad.2019.108700. Epub 2019 Oct 15.

Laughlin-Tommaso S, Barnard EP, AbdElmagied AM, Vaughan LE, Weaver AL, Hesley GK, Woodrum DA, Jacoby VL, Kohi MP, Price TM, Nieves A, Miller MJ, Borah BJ, Moriarty JP, Gorny KR, Leppert PC, Severson AL, Lemens MA, Stewart EA. FIRSTT study: randomized controlled trial of uterine artery embolization vs focusedultrasound surgery. Am J Obstet Gynecol. 2019 Feb;220(2):174.e1-174.e13. doi: 10.1016/j.ajog.2018.10.032. Epub 2018 Oct 26.

Liu X, Xue L, Wang Y, Wang W, Tang J. Vaginal delivery outcomes of pregnancies following ultrasound-guided high-intensity focused ultrasound ablation treatment for uterine fibroids. Int J Hyperthermia. 2018 Oct 25:1-8. doi: 10.1080/02656736.2018.1510548.

Click here for additional references from PubMed.

Animated treatment video courtesy of Insightec

 

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