Safety Information

Device Description

The Sonata Sonography-Guided Transcervical Fibroid Ablation System provides radiofrequency (RF) ablation of uterine fibroids (myomata; leiomyomata uteri) using a transcervical approach without incisions or material uterine distension.

The Sonata System is comprised of durable medical equipment, software, and various single-use and reusable instruments. A Radiofrequency Ablation (RFA) Handpiece attaches to an Intrauterine Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the assembly of the RFA Handpiece and the IUUS Probe is referred to as the Treatment Device. The Sonata Graphical Guidance Software (GGS) integrates ablation planning, targeting, and ablation of fibroids. The SMART Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation. The system enables a clinician to deliver radiofrequency energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.

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

The Sonata System is contraindicated in the following conditions:

• 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.

Other Considerations

• Safety and effectiveness with regard to fertility and fecundity after the 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.
• Effectiveness in women with clinically significant adenomyosis has not been established.
• Transcervical radiofrequency ablation with the Sonata System should not be performed in patients with known hip implants or other metal implants near the ablation site or along the RF return path to Dispersive Electrodes.
• The Sonata System should be used with caution in patients with a known nickel allergy.
• Other considerations as stated in the Sonata System Operator’s Manual.

Patient Counseling, Potential Postoperative Events, and Risks

As with any procedure, the clinician should discuss the potential risks and expected outcomes related to the Sonata procedure with patients. The Sonata System is intended for the transcervical ablation of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding. Full benefits may not be realized for several months, as the ablated fibroids shrink over time.

• Anticipated postoperative events include: abdominopelvic pain/cramping; back pain; constipation; dizziness/fatigue; headache; fever; malaise; post-ablation inflammatory symptoms; nausea/vomiting; sloughing and, less commonly, intact expulsion of ablated fibroid tissue per vaginam (particularly after ablation of submucous fibroids), and vaginal spotting/bleeding/dysmenorrhea.
• Potential risks associated with fibroid ablation using the Sonata System include: allergic reactions (including rash) to device materials; bowel or bladder perforation; cervical/vaginal laceration or tear; dysmenorrhea; electrical shock; hematometrium; hemorrhage; infections: major and minor local and systemic infections, including intrauterine infection; retention of device fragment; skin burn from the dispersion of radiofrequency energy; thrombotic events; unintended injury to the uterus, cervix or vaginal vault, adjacent organs or tissue; unknown risk to future pregnancies; and complications including death.

ML 04858-018 Rev D