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Now 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 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

Sonata is SMARTSetting 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
SMART Image

12-Month Results of SONATA Pivotal IDE Trial*

Surgical-reintervention
Satisfied-with-treatment
Return-to-normal-activity

Indications 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.

For full safety information, click here.

* 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