FAQ for Healthcare Professionals

As a uterus-conserving alternative to hysterectomy, treatment with Sonata does not eliminate the possibility of pregnancy.

While there is literature to suggest that ablation of >20% of a fibroid’s volume is sufficient for symptom relief through two years, it is apparent that larger percentages are preferable and associated with long term efficacy.¹

1. Stewart, Gostout, Rabinovici, Kim,, et al. Clinical Benefit of Focused Ultrasonography. Am College of Ob and Gyn. VOL. 110, NO. 2, PART 1, AUGUST 2007.

In the SONATA Trial, up to 10 fibroids were treated in enrolled patients. The Instructions for Use for the Sonata System does not specify an upper limit to the number of fibroids treated in a single session. How many fibroids to treat will depend on physician judgment.

The procedural time is determined by the number and size of fibroids being treated. Each ablation ranges from 1-7 minutes, plus temperature ramp up time. The ablation time is determined automatically by the system based on the size of the ablation zone the physician has set. In the SONATA Trial, the mean procedure time was 47 minutes with a mean of 3 fibroids treated.

It is important that patients understand that this is not an instant fix for fibroid symptoms, as may be expected with myomectomy or hysterectomy. Most women reported improvements in heavy menstrual bleeding within 3 months.

The choice of anesthesia is a clinical decision that is based on multiple considerations, such as BMI, anesthesiologist input, and patient and clinician preferences. Sonata clinical trials were conducted with a variety of anesthesia regimens including general or regional and conscious sedation.