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 noninvasive 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.

How it Works
Focused ultrasound energy heats and destroys the targeted tissue at the focal point. This process is repeated until the entire selected volume is destroyed.

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

There is a clinical trial in the Netherlands, which is a 2:1 randomized trial comparing MRI-guided focused ultrasound to other treatments (hysterectomy, myomectomy, or uterine artery ablation). See the website for this trial, called MYCHOICE, for more information. 

There is a clinical trial in Germany, that is a randomized trial comparing MRI-guided focused ultrasound to myomectomy.

There is a clinical trial in Turku, Finland, that is using focused ultrasound to treat uterine fibroids.

There is a clinical trial in Canada using MRI-guided focused ultrasound to treat uterine leiomyomas. This trial is only open to Canadian citizens.

See a list of treatment sites > 
See a list of clinical trials sites >
See a list of laboratory research sites >

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

Zheng Y, Chen L, Liu M, Wu J, Yu R, Lv F. Prediction of Clinical Outcome for High-Intensity Focused Ultrasound Ablation of Uterine Leiomyomas Using Multiparametric MRI Radiomics-Based Machine Leaning Model. Front Oncol. 2021 Sep 10;11:618604. doi: 10.3389/fonc.2021.618604. eCollection 2021.

Sainio T, Saunavaara J, Komar G, Otonkoski S, Joronen K, Viitala A, Perheentupa A, Blanco Sequeiros R. Feasibility of T2 relaxation time in predicting the technical outcome of MR-guided high-intensity focused ultrasound treatment of uterine fibroids. Int J Hyperthermia. 2021;38(1):1384-1393. doi: 10.1080/02656736.2021.1976850.

Ciccarone F, Biscione A, Lorusso D, Zannoni GF, Cina A, Ferrandina G, Scambia G, Testa AC. Uterine leiomyosarcoma diagnosis 5 years after high-intensity focused ultrasound treatment under magnetic resonance guidance for fibroid. Ultrasound Obstet Gynecol. 2021 Sep 16. doi: 10.1002/uog.24775.

Liu Y, Wu X, Wu A, Gong C, Wang Z, Zhang L. Ultrasound-guided high intensity focused ultrasound ablation for uterine fibroids: long-term outcomes and factors affecting local recurrence. Int J Hyperthermia. 2021;38(1):1341-1348. doi: 10.1080/02656736.2021.1973585.

Zheng Y, Chen L, Liu M, Wu J, Yu R, Lv F. Nonenhanced MRI-based radiomics model for preoperative prediction of nonperfused volume ratio for high-intensity focused ultrasound ablation of uterine leiomyomas. Int J Hyperthermia. 2021;38(1):1349-1358. doi: 10.1080/02656736.2021.1972170.

Rodríguez J, Isern J, Pons N, Carmona A, Vallejo E, Cassadó J, De Marcos JA, Paraira M, Giménez N, Pessarrodona A. Pregnancy outcomes after ultrasound-guided high-intensity focused ultrasound (USgHIFU) for conservative treatment of uterine fibroids: experience of a single institution. Int J Hyperthermia. 2021 Sep;38(2):9-17. doi: 10.1080/02656736.2021.1908633.

Wang Q, Wu X, Zhu X, Wang J, Xu F, Lin Z, Gong C, He M, Zhang L. MRI features and clinical outcomes of unexpected uterine sarcomas in patients who underwent high-intensity focused ultrasound ablation for presumed uterine fibroids. Int J Hyperthermia. 2021 Sep;38(2):39-45. doi: 10.1080/02656736.2021.1921288.

Xu F, Deng L, Zhang L, Hu H, Shi Q. The comparison of myomectomy, UAE and MRgFUS in the treatment of uterine fibroids: a meta analysis. Int J Hyperthermia. 2021 Sep;38(2):24-29. doi: 10.1080/02656736.2021.1933216.

Marinova M, Ghaei S, Recker F, Tonguc T, Kaverina O, Savchenko O, Kravchenko D, Thudium M, Pieper CC, Egger EK, Mustea A, Attenberger U, Conrad R, Hadizadeh DR, Strunk H. Efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) for uterine fibroids: an observational single-center study. H.Int J Hyperthermia. 2021 Sep;38(2):30-38. doi: 10.1080/02656736.2021.1939444.

Xu F, Deng L, Zhang L, Hu H, Shi Q. The comparison of myomectomy, UAE and MRgFUS in the treatment of uterine fibroids: a meta analysis. Int J Hyperthermia. 2021 Sep;38(2):24-29. doi: 10.1080/02656736.2021.1933216.

Laughlin-Tommaso SK, Gorny KR, Hesley GK, Vaughan LE, Woodrum DA, Lemens MA, Stewart EA. Uterine and Fibroid Imaging Analysis from the FIRSTT Study. J Womens Health (Larchmt). 2021 Jul 8. doi: 10.1089/jwh.2020.8892. Online ahead of print.

Wang CJ, Lin G, Huang YT, Weng CH, Wu KY, Su YY, Lin YS, Mak KS. A feasibility analysis of the ArcBlate MR-guided high-intensity focused ultrasound system for the ablation of uterine fibroids. Abdom Radiol (NY). 2021 Jul 9. doi: 10.1007/s00261-021-03203-8.

Yang MJ, Yu RQ, Chen WZ, Chen JY, Wang ZB. A Prediction of NPVR 80% of Ultrasound-Guided High-Intensity Focused Ultrasound Ablation for Uterine Fibroids. Front Surg. 2021 Jun 4;8:663128. doi: 10.3389/fsurg.2021.663128. eCollection 2021.

Zhou Y, Ji X, Niu J, Sun T, Qian Z, Li Y, Yuan J, Fan Q, Huang Q, Bai J, Wang Y. Ultrasound-Guided High-Intensity Focused Ultrasound for Devascularization of Uterine Fibroid: A Feasibility Study. Ultrasound Med Biol. 2021 Jun 16:S0301-5629(21)00242-8. doi: 10.1016/j.ultrasmedbio.2021.05.012.

Tsai MC, Chang LT, Tam KW. Comparison of High-Intensity Focused Ultrasound and Conventional Surgery for Patients with Uterine Fibroids: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2021 Jun 11:S1553-4650(21)00281-8. doi: 10.1016/j.jmig.2021.06.002.

Anneveldt KJ, van 't Oever HJ, Nijholt IM, Dijkstra JR, Hehenkamp WJ, Veersema S, Huirne JAF, Schutte JM, Boomsma MF. Systematic review of reproductive outcomes after High Intensity Focused Ultrasound treatment of uterine fibroids. Eur J Radiol. 2021 May 27;141:109801. doi: 10.1016/j.ejrad.2021.109801.

Karacharova IY, Kozarenko TM, Flaksemberg MA, Kornatska AG, Kondratiuk VK, Nikitina IM. Interdisciplinary Interaction in Maintaining the Reproductive Health in Women with Uterine Leyomyoma. Wiad Lek. 2021;74(5):1152-1157.

Łoziński T, Ciebiera M, Łuczyńska E, Filipowska J, Czekierdowski A. Magnetic Resonance-Guided High-Intensity Focused Ultrasound Ablation of Uterine Fibroids-Efficiency Assessment with the Use of Dynamic Contrast-Enhanced Magnetic Resonance Imaging and the Potential Role of the Administration of Uterotonic Drugs. Diagnostics (Basel). 2021 Apr 16;11(4):715. doi: 10.3390/diagnostics11040715.

Lozinski T, Filipowska J, Pyka M, Baczkowska M, Ciebiera M. Magnetic resonance-guided high-intensity ultrasound (MR-HIFU) in the treatment of symptomatic uterine fibroids - five-year experience. Ginekol Pol. 2021 Apr 30. doi: 10.5603/GP.a2021.0098.

Łoziński T, Ludwin A, Filipowska J, Zgliczyńska M, Węgrzyn P, Kluz T, Ciebiera M. Oxytocin and Misoprostol With Diclofenac in the Preparation for Magnetic Resonance-Guided High-Intensity Ultrasound Treatment of Symptomatic Uterine Fibroids: A Prospective Cohort Study. Ultrasound Med Biol. 2021 Jun;47(6):1573-1585. doi: 10.1016/j.ultrasmedbio.2021.02.018. Epub 2021 Mar 28.

Gong C, Lin Z, Lv F, Zhang L, Wang Z. Magnetic resonance imaging parameters in predicting the ablative efficiency of high-intensity focused ultrasound for uterine fibroids. Int J Hyperthermia. 2021;38(1):523-531. doi: 10.1080/02656736.2021.1904152.

Liao P, Jiang J, Zeng YH, Chen Y, Yong M, Qu DC, Zhou HG. Comparison of outcomes of hysteroscopic myomectomy of type 2 submucous fibroids greater than 4 cm in diameter via pretreatment with HIFU or GnRH-a. Int J Hyperthermia. 2021;38(1):183-188. doi: 10.1080/02656736.2021.1874546.

Ierardi AM, Carnevale A, Pellegrino F, Stefano GD, Bonelli C, Renzulli M, Giganti M, Carrafiello G. Uterine Myomas: Extravascular Treatment. Semin Ultrasound CT MR. 2021 Feb;42(1):56-74. doi: 10.1053/j.sult.2020.08.004. Epub 2020 Aug 29.

Napoli A, Alfieri G, Andrani F, Scipione R, Manganaro L, Pecorini F, Catalano C. Uterine Myomas: Focused Ultrasound Surgery. Semin Ultrasound CT MR. 2021 Feb;42(1):25-36. doi: 10.1053/j.sult.2020.08.001. Epub 2020 Aug 21.

Sainio T, Saunavaara J, Komar G, Mattila S, Otonkoski S, Joronen K, Perheentupa A, Blanco Sequeiros R. Feasibility of apparent diffusion coefficient in predicting the technical outcome of MR-guided high-intensity focused ultrasound treatment of uterine fibroids - a comparison with the Funaki classification. Int J Hyperthermia. 2021;38(1):85-94. doi: 10.1080/02656736.2021.1874545.

Melkozerova O, Shchedrina I, Gryshkina A, Bashmakova N, Malgina G, Michelson A, Chistyakova G. How noninvasive treatment of uterine fibroids affects endometrial receptivity: a prospective cohort study. Gynecol Endocrinol. 2020;36(sup1):28-32. doi: 10.1080/09513590.2020.1816725.

Zhang DL, Wu SS, Chen S, Liu XX, Tang JQ, Lin N, Ding GS, Li GP. Differences in the therapeutic effects of high-intensity focused ultrasound (HIFU) ablation on uterine fibroids with different shear wave velocity (SWV): a study of histopathological characteristics. Int J Hyperthermia. 2020;37(1):1322-1329. doi: 10.1080/02656736.2020.1849827.

Liu L, Wang T, Lei B. Uterine Artery Embolization Compared with High-intensity Focused Ultrasound Ablation for the Treatment of Symptomatic Uterine Fibroids: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2020 Nov 13:S1553-4650(20)31122-5. doi: 10.1016/j.jmig.2020.11.004.

Lee JY, Kim K, Hwang SI, Lee M, Son K, Kim D, Kim S, Kim YB. Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial. Eur J Obstet Gynecol Reprod Biol. 2020 Nov 17;256:302-307. doi: 10.1016/j.ejogrb.2020.11.049.

Yang C, Huang Q, Ji X, Bai J. Fusion of Multiple-angles Intraoperative US Images and Pretreatment MR Images for USgHIFU Treatment of Uterine Fibroid: Retrospective Evaluation Based on Clinical Dataset. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:5236-5239. doi: 10.1109/EMBC44109.2020.9175248.

Jeng CJ, Long CY, Chuang LT. Comparison of magnetic resonance-guided high-intensity focused ultrasound with uterine artery embolization for the treatment of uterine myoma: A systematic literature review and meta-analysis. Taiwan J Obstet Gynecol. 2020 Sep;59(5):691-697. doi: 10.1016/j.tjog.2020.07.012.

Li W, Jiang Z, Deng X, Xu D. Long-term follow-up outcome and reintervention analysis of ultrasound-guided high intensity focused ultrasound treatment for uterine fibroids. Int J Hyperthermia. 2020;37(1):1046-1051. doi: 10.1080/02656736.2020.1807617.

Liu X, Dong X, Mu Y, Huang G, He J, Hu L. High-intensity focused ultrasound (HIFU) for the treatment of uterine fibroids: does HIFU significantly increase the risk of pelvic adhesions? Int J Hyperthermia. 2020;37(1):1027-1032. doi: 10.1080/02656736.2020.1811903.

Liu C, Chen B, Tang X, Xiong Y. Disseminated peritoneal leiomyomatosis after uterine artery embolization, laparoscopic surgery, and high intensity focused ultrasound for uterine fibroids: a case report. Int J Hyperthermia. 2020;37(1):925-928. doi: 10.1080/02656736.2020.1797909.


Click here for additional references from PubMed.

Animated treatment video courtesy of Insightec

 

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