Trial Information

Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

After the PMA Panel, the sponsor was requested to conduct a post-approval study. The
objective of this study is to gather additional data to evaluate the safety and long term
effectiveness of focused ultrasound treatment, and to include a larger cohort of
African-American patients. Patients will be treated following the approved commercial
treatment guidelines.

Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These
benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR
imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They
occur in 20-25% of women of reproductive age and can cause a variety of problems generally
described as either bleeding or mass effects from the fibroid. In general, these symptoms
can be classified into two categories:

1. heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of
sanitary wear every 2 hours or less, significant clot passage, flooding, substantial
prolongation of menstrual periods compared with the patient's prior experience, or
anemia.

2. pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back,
flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in
nocturia, difficulty voiding or compression of the ureters with hydronephrosis.

Measures of the clinical success of patients who elect treatment of fibroids are generally
subjective, and evaluated by the patient in terms of improvement in the initial symptoms
that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction
in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment
itself.