The Sonata® System

so∙na∙ta noun \sә-‘nä-tә\

The Sonata [Sonography-Guided Transcervical Fibroid Ablation] System provides radiofrequency (RF) ablation of uterine fibroids using a transcervical approach without incisions. The Sonata System has CE Mark and is approved for sale in the European Union.

The RFA Handpiece attaches to and works with an intrauterine ultrasound (IUUS) probe that provides real-time sonography from within the uterus.

The system includes software to guide the treatment planning, targeting, and ablation of fibroids. Radiofrequency energy is applied within a targeted fibroid which may result in fibroid volume reduction and relief of symptoms.

The Sonata System is comprised of capital medical equipment, software, and various disposable and reusable instruments.

SonataSys-Logo_RGB

 

 

 

 

 

Sonata-System-illustration

 

SMART Guide

Setting Margins of Ablation in Real Time

The SMART™ Guide displays a real-time graphic overlay on the live ultrasound image for targeting and deployment of radiofrequency ablation.

The graphic overlay is controlled by the operator using the RFA handpiece to determine:

  • Size and location of ablation
  • Mechanical stops for Introducer and Needle Electrode advancement
  • Duration of radiofrequency energy delivery

SMART Image

The Ablation Zone (inner red ellipse) – a two-dimensional representation of the average region of tissue ablation for the selected ablation size.

Thermal Safety Border (outer green ellipse) – the distance at which tissue is safe from the potential of thermal damage.

 PALM-COEIN Classification

PALM-COEIN is a classification system developed by the International Federation of Gynecology and Obstetrics (FIGO) to create uniform nomenclature for the causes of abnormal uterine bleeding.

The Sonata System is designed to completely or partially ablate fibroid types 1,2,3,4,5,6 and 2-5. These are colored green in the diagram below.

 

FIGO Classification

Safety Summary

Potential Postoperative Events and Risks: Abdominopelvic pain/cramping; back pain; constipation; dizziness/fatigue; headache; fever; malaise; nausea/vomiting; sloughing and, less commonly, intact expulsion of ablated fibroid tissue per vaginam (particularly after treatment of submucous fibroids); vaginal spotting/bleeding/dysmenorrhea.

Uncommon risks associated with fibroid ablation using the Sonata System include: allergic reactions; electrical shock; hematometrium; hemorrhage; infection; retention of device fragment; skin burn; thrombotic event; unintended injury to the uterus, cervix, vagina, adjacent organs or tissue.

Adenomyosis: Effectiveness in women with clinically significant adenomyosis has not been established.

Pregnancy: Safety and effectiveness with regard to fertility and fecundity after use of the Sonata System have not been established.