MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

Inclusion Criteria:

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

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

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

4. Able to communicate sensations during the ExAblate procedure.

5. 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).

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

Exclusion Criteria:

1. Metallic implants that are incompatible with MRI

2. Sensitive to MRI contrast agents

3. Severe claustrophobia that would prevent completion of procedure in MR unit

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

5. Pedunculated fibroids

6. Active pelvic inflammatory disease (PID)

7. Active local or systemic infection

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

9. Intrauterine device (IUD) anywhere in the treatment path

10. Dermoid cyst of the ovary anywhere in the treatment path

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

12. Undiagnosed vaginal bleeding