About Sonata System
About the SONATA SYSTEM
Transcervical Fibroid Ablation for Treatment of Symptomatic Uterine Fibroids
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.
A New Point of View
The Sonata System combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure to treat symptomatic uterine fibroids.
- Delivers a breakthrough alternative to hysterectomy and myomectomy
- Transcervical delivery avoids the peritoneal cavity and does not require general anesthesia
- Treats most fibroid types including submucous, intramural, transmural, and subserous
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The Sonata System utilizes the open-source FFmpeg (version 5.1.0, available at https://www.ffmpeg.org/ under the GPL license for encoding video in MP4 format from captured screen frames) and the open-source Com0Com (version 3.0.0.0 x64, available at https://com0com.sourceforge.net/ under the GPL license to create virtual serial ports).
SONATA Pivotal IDE Trial Results Through 3 Years1,2
1. Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas. Obstet Gynecol. 2019; 133:13-22.
2. 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.
Frequently Asked Questions
Find answers to a few of the questions most frequently asked by healthcare professionals.
Medical and Scientific Information Request
Requests for additional medical and scientific information can be submitted to our Medical Director through the following form.
Education Resource Center
Find a collection of physician training, patient and referring physician awareness content, and materials to help prepare office staff for accepting new patients. Please contact your Sonata representative for access or contact us.
Instructions for Use
Electronic versions of Sonata System instructions for use (IFU) are available on our company site.
Indication and Safety Information
The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
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