About the Sonata Treatment
The Sonata Treatment is an incision-free treatment for uterine fibroids and has been clinically proven to be safe and effective.*
The Sonata Treatment uses an intrauterine ultrasound handpiece to locate and target the individual fibroids. Radiofrequency energy is delivered to shrink the fibroid and reduce symptoms.
Why is the Sonata Treatment a breakthrough?
Sonata can treat a wide range of fibroid types, sizes, and locations — without even one incision.
The fibroids are treated from inside the uterus, so the Sonata Treatment requires no incisions to the abdomen, no tissue is surgically removed, and the uterus is preserved.
The SONATA Clinical Trial
Women were surveyed 12 months after their Sonata Treatment and reported the following results:*
- 97% would recommend Sonata treatment to a friend
- 95% reported a reduction in menstrual bleeding
- 50% returned to normal activity the next day
Intended Use and Safety Information
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. Contraindications: Current pregnancy; active pelvic infection; known or suspected gynecologic malignancy or premalignant disorders such as atypical endometrial hyperplasia; presence of one or more intratubal implants for sterilization; and presence of an intrauterine device (IUD), unless removed prior to the introduction of the Sonata Treatment Device. Common Side Effects include bleeding, spotting, cramping, post-ablation inflammatory symptoms, and/or discharge. Potential Risks include bowel or bladder injury; hematometrium; hemorrhage; infection; retention of device fragment; skin burn; thrombotic events; unintended injury to the uterus, cervix or vaginal vault, adjacent organs or tissue; unknown risk to future pregnancies; and complications including death. Pregnancy: Safety and effectiveness with regard to fertility and fecundity after use of the Sonata System have not been established. As a uterus-conserving alternative to hysterectomy, treatment with the Sonata System does not eliminate the possibility of pregnancy. View Additional Safety Information.
* Reference for the published clinical trial results: 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 Jan; 133(1): 13-22