FDA Cleared for Treatment of Symptomatic Uterine Fibroids
The Sonata® System combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure to treat symptomatic uterine fibroids.
- Delivers an innovative 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 fibroids
Sonata is SMART: Setting Margins of Ablation in Real Time
The SMART Guide:
- Displays real-time graphic overlay on the live ultrasound image
- Provides safe targeting and delivery of radiofrequency ablation
The graphic overlay is controlled by the operator to determine:
- Size and location of ablation zone
- Safety borders
- Duration of radiofrequency energy delivery
12-Month Results of SONATA Pivotal IDE Trial*
* Clinical Results from SONATA Pivotal IDE Trial: Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza-Leal JG. Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas. Obstet Gynecol. 2019 Jan; 133(1): 13-22
Intended Use: The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. View Safety Information.