The Sonata System

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.

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