As of January 1, 2024, Sonata will have a new Category I CPT® code, 58580 (Transcervical ablation of uterine fibroid(s), including intraoperative ultrasound guidance and monitoring, radiofrequency).
The temporary Category III code 0404T (Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency) will be deleted and no longer accepted as of January 1, 2024.
KEY PUBLICATIONS
SONATA Pivotal IDE Trial: 3-Year Results
Lukes A, Green MA. Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata. J Gynecol Surg. 2020;36:5, 228-233.
SONATA Pivotal IDE Trial: 12-Month Results (FDA Submission)
Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas: The SONATA Trial. Obstet Gynecol. 2019; 133(1): 13-22.
Additional Selected Clinical Publications
Römer T, Bends R, Christoffel L, et al. Treatment of Symptomatic Fibroids with Transcervical Ultrasound-guided Radiofrequency Ablation. Indication, procedure, results, and complications—2020 expert consensus. Part 2: Transcervical Radiofrequency Ablation (TRFA)–Methods, indications, results, and comparison with other therapies. Frauenarzt. 2021;162-168.*
Christoffel L, Römer T, Schiermeier S. Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. Med Devices (Auckl). 2021;14:77-84.
Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata® system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021;79-85.
Garza-Leal JG. Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study. Journal of Gynecologic Surgery. 2019; 35:19-23.
Brölmann H, Bongers M, Garza-Leal J, Gupta J, et al. The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. 2016; 13: 27-35.
Taheri M, Galo L, Potts C, Sakhel K, Quinn SD. Nonresective treatments for uterine fibroids: a systematic review of uterine and fibroid volume reductions. International Journal of Hyperthermia. 2019; 1-7.
Huirne J, Brooks E. Improvement in health utility after transcervical radiofrequency ablation of uterine fibroids with the Sonata System: Health utility after radiofrequency ablation. Eur J Obstet Gynecol Reprod Biol. 2018; 224: 175-180.
Toub, DB. A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System. Curr Obstet Gynecol Rep. 2017;6(1):67-73.
Bongers M, Brölmann H, Gupta J, Garza-Leal JG, Toub D. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study. Gynecol Surg. 2015;12(1):61-70.
Jones, S., O'Donovan, P, Toub, D, Radiofrequency Ablation for Treatment of Symptomatic Uterine Fibroids. Obstet Gynecol Int. 2012;194839.
Garza-Leal, JG, Toub, D, León, IH, et al. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting. Gynecol Surg. 2011; 8: 327.
*Translated from original German publication. Römer T, Bends R, Christoffel L, et al. Behandlung von symptomatischen Myomen mit der transzervikalen ultraschallgesteuerten Radiofrequenzablation-Indikationen, Durchführung, Ergebnisse und Komplikationen-Expertenkonsensus 2020. Teil 2: Die transzervikale Radiofrequenzablation (TRFA) – Methode, Indikationen, Ergebnisse und Vergleich mit anderen Therapien. Frauenarzt. 2021;162-168.