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) * A…