ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

Exclusion Criteria

• •1. Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
• •2. Uterine size \>24 weeks.
• •3. Patients with pedunculated fibroids
• •4. Patients with active pelvic inflammatory disease (PID).
• •5. Patients with active local or systemic infection
• •6. Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months
• •7. Contraindication for MRI Scan:
• •* Severe claustrophobia that would prevent completion of procedure in the MR unit
• •* Metallic implants that are incompatible with MRI
• •* Sensitivity to MRI contrast agents
• •* Any other contraindication for MRI Scan
• •8. Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam)
• •9. Dermoid cyst of the ovary anywhere in the treatment path.
• •10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
• •11. Intrauterine device (IUD) anywhere in the treatment path
• •12. Undiagnosed vaginal bleeding