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

Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia

The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.

Inclusion Criteria:

• Female
• Age 18-55 years
• Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology
• Patients able and willing to provide informed consent

Exclusion Criteria:

• Visible scar within the HIFU beam path that cannot be avoided
• Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall
• Currently pregnant or desire to become pregnant in the future
• Pelvic malignancy
• Pelvic congenital malformation
• Acute pelvic infection
• Otherwise determined by a physician to be inappropriate for the study