SMART OS 2.4

SMART GUIDE: NEW SMART OS™ 2.4

Smart Guide: Setting Margins

for Ablation in Real Time

The Sonata System includes a SMART guide, with a graphical user interface that displays the ablation zone directly over the intended treatment area on the ultrasound display.

It’s the only system with a thermal safety border that automatically adjusts relative to the ablation zone, indicating the safe distance from potential thermal damage

THE PROPRIETARY SMART GUIDE

Provides a graphical overlay on a live ultrasound image to avoid effects on tissue beyond the Thermal Safety Border.
Immediately updates the Thermal Safety Border as the physician adjusts the planned Ablation Zone.
Automatically controls RF delivery to achieve the planned ablation size without the need for calculation or look-ups.

SMART OS 2.4 IMPROVEMENTS OF THE SMART GUIDE:

Reduced smallest Ablation Zone from 2.0 x 1.3 cm to 1.6 x 1.2 cm
38% ablation volume reduction
Optimized margin of Thermal Safety Border for smaller ablation sizes

Precision. Control. Flexibility.

With the new SMART OS 2.4 software for the Sonata System, you are able to treat more fibroids,

while preserving normal uterine tissue.

MORE PRECISION FOR INTRAMURAL FIBROIDS

Experience greater flexibility and versatility in making controlled ablations confined to the fibroid, avoiding adjacent uterine tissue if desired.

MORE PRECISION FOR INTRAMURAL FIBROIDS
Experience greater flexibility and versatility in making controlled ablations confined to the fibroid, avoiding adjacent uterine tissue if desired.

MORE FLEXIBILTY – TREAT A WIDER RANGE OF FIBROID SIZES

Sonata is the only fibroid ablation system that has a Thermal Safety Border, which allows gynecologists to graphically tailor the desired ablation to the targeted fibroid. Sonata provides a 40-fold range from the smallest to the largest ablation volume.

Want to learn more about the Sonata System?

IMPORTANT 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 pre- malignant 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 symp- toms, 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.

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