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.

Inclusion Criteria:

- Women who present with symptomatic uterine fibroids and are not seeking treatment for
the reason of improving fertility.

- Able and willing to give consent and able to attend all study visits.

- Patient is pre or peri-menopausal (within 12 months of last menstrual period).

- Able to communicate sensations during the ExAblate procedure.

- Uterine fibroids, which are device accessible (i.e., positioned in the uterus such
that they can be accessed without being shielded by bowel or bone).

- Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

- Metallic implants that are incompatible with MRI

- Sensitive to MRI contrast agents

- Severe claustrophobia that would prevent completion of procedure in MR unit

- Who are pregnant or desire to become pregnant in the future. Pregnancies following
ExAblate treatment could be dangerous for both mother and fetus.

- Pedunculated fibroids

- Active pelvic inflammatory disease (PID)

- Active local or systemic infection

- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and
adenomatous hyperplasia

- Intrauterine device (IUD) anywhere in the treatment path

- Dermoid cyst of the ovary anywhere in the treatment path

- Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g.,
due to Caesarean section or repeated abdominal surgeries)

- Undiagnosed vaginal bleeding