Safety Study of ExAblate for the Treatment of Uterine Fibroids

Inclusion Criteria:

- Women age 18 or older

- Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher,
based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and
Health-Related Quality of Life Questionnaire (UFS-QOL)

- Women who have given written informed consent

- Women who are able and willing to attend all study visits.

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

- Patient should be family complete.

- 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.

- Fibroid enhances on MR contrast imaging.

Exclusion Criteria:

- Women who are pregnant, as confirmed by serum/urine test at time of screening, or
urine pregnancy test on the day of treatment.

- Patients who are breast-feeding.

- Patients with active pelvic inflammatory disease (PID).

- Patients with active local or systemic infection.

- Patients experiencing chronic leg or lower back pain within the last 6 months.

- Contraindication for MRI Scan:

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

- Weight greater than 250 lbs (113Kg)

- Implanted ferromagnetic materials and/or devices contraindicated for MR scan

- Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)

- Any other contraindication for MRI Scan

- Extensive abdominal scarring in the beam path (that cannot be avoided by redirection
of the beam).

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

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

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

- Undiagnosed vaginal bleeding.

- Pedunculated fibroids.

- Uterine size >24 weeks.