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 StimulatingHormone (FSH) level < 40 IU/L

• Willing and able to attend all study visits

• Willing and able to complete Menstrual Blood Loss (MBL) assessment with AlkalineHematin (AH) method

• Willing and able to use reliable contraception methods

• Uterine size < 24 weeks

• Cervical cell assessment by Pap smear: Normal, Low Grade Squamous IntraepithelialLesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells ofUncertain Significance (ASCUS) subtypes of cervical tissue

• MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroidvolume can be treated.

• Fibroids selected for treatment meeting the following criteria (further extrapolatedin 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 oftreated volume becomes ambiguous

• Patient's self-assessment indicates that she has had episodes of heavy menstrualbleeding 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 T2contrast obtained using the Philips MR-HIFU MR protocol) fibroids

• Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurementsare not feasible)

• Menses lasting > 7 days or intermenstrual bleeding (patient can be included if thereis endometrial biopsy within 6 months to exclude malignancy)

• Patient is currently on hormonal medication for fibroids or has a hormonal medicationhistory 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