Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

Inclusion Criteria: * Women, age between 18 and 50 years * Ethnicity has a match with the intended profile for the site * Weight \< 140kg or 310lbs * Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level \< 40 IU/L * Willing and able to attend all study visits * Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method * Willing and able to use reliable contraception methods * Uterine size \< 24 weeks * Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue * MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated. * Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol): 1. Total planned ablation volume of all fibroids should not exceed 250 ml and 2. No more than 5 fibroids should be planned for ablation and 3. Dominant fibroid (diameter) is greater than or equal to 3 cm and 4. Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous * Patient's self-assessment indicates that she has had episodes of heavy menstrual bleeding in the past 6 months. * Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml Exclusion Criteria: * Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) * Desire for future pregnancy * Significant systemic disease even if controlled * Positive pregnancy test * Hematocrit \< 25% * Extensive scarring along anterior lower abdominal wall (\>50% of area) * Surgical clips in the potential path of the HIFU beam * MRI contraindicated * MRI contrast agent contraindicated (including renal insufficiency) * Calcifications around or throughout uterine tissues that may affect treatment * Communication barrier * Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids * Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible) * Menses lasting \> 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy) * Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below: 1. 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or 2. 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or 3. Depo Provera or equivalent: less than 6 months prior to MBL measurement