Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

Inclusion Criteria:

1. Female patients 18 years or older diagnosed with breast fibroadenoma and presentingat least one fibroadenoma.

2. Diagnosis of fibroadenoma must be based on:

3. Clinical examination

4. Ultrasound image alone for patients under 35 years old. For women older than 35years, a mammogram will be performed in addition to ultrasound. The BI-RADSscore of this mammogram must be 2 or 3. BI-RADS score of 4 is eligible ifbiopsy indicates fibroadenoma with concordance.

5. Histologic confirmation by core needle biopsy.

6. Patient is a candidate for the surgery.

7. The fibroadenoma treatment volume must be at least 5 mm and no more than 26 mm fromthe skin. This criterion should be evaluated immediately prior treatment, once thebreast is immobilized and potentially compressed.

8. The rib cage should not be in the prefocal ultrasound path or behind the targetfibroadenoma (minimum distance from the posterior wall of the fibroadenoma must beat least 10 mm). This criterion shall be evaluated immediately prior to treatment,once breast is immobilized and potentially compressed.

9. The fibroadenoma is 1 cm or greater at its largest dimension and no less than 7.5 mmin the anterior-posterior dimension (measured by ultrasound). Focal point for HIFUtreatment must also be at least 3 mm from any border of the fibroadenoma.

10. Patient's fibroadenoma size is greater or equal to 0.2 cc and less than 10 cc involume (measured by ultrasound on the day of the procedure).

11. Fibroadenoma is palpable.

12. Pain ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days

13. Anxiety ≥ 30mm/100mm measured on VAS as a maximum level during the last 30 days

14. Patient has signed a written informed consent.

Exclusion Criteria:

1. Patient is pregnant or nursing.

2. Presence of calcified fibroadenoma. Calcification will be determined withmammography. In women > 35 years old, the diagnostic mammogram should be evaluatedfor calcification. In women ≤ 35 years old, a single view mammogram of the affectedbreast is sufficient for evaluation of calcification. Women ≤ 35 years old will beexcluded based on the findings of calcification on a single view mammogram.

3. Patient with history of breast cancer or history of laser or radiation therapy tothe target breast.

4. Patient with breast implants in the target breast.

5. Patient with a breast cyst within the fibroadenoma to be treated.

6. Patient's fibroadenoma not clearly visible on the ultrasound images (in B mode) atthe inclusion visit.

7. Patient participating in another clinical trial involving an investigational drug,device or biologic.