Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids

Evaluation of All Adverse Events Encountered

Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.

Time frame: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).