Treatment of Breast Fibroadenoma Targeted Tissue With HIFU

Echopulse is specially designed, manufactured and CE marked for treating breast fibroadenoma.
HIFU is a completely alternative to surgery which utilizes high-energy ultrasound to deliver
a large amount of sound energy to a focal point to rapidly induce tissue heating to
85-90°C.This initiates tissue coagulation followed by tissue necrosis ablating the targeted
area.

Inclusion Criteria:

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

2. Diagnosis of fibroadenoma must be based on:

1. Clinical examination

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

3. Histologic confirmation by core needle biopsy.

3. Patient is a candidate for the surgery.

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

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

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

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

8. Fibroadenoma is palpable.

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

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

11. Patient has signed a written informed consent.

Exclusion Criteria:

1. Patient is pregnant or nursing.

2. Presence of calcified fibroadenoma. Calcification will be determined with mammography.
In women > 35 years old, the diagnostic mammogram should be evaluated for
calcification. In women ≤ 35 years old, a single view mammogram of the affected breast
is sufficient for evaluation of calcification. Women ≤ 35 years old will be excluded
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 to the
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) at the
inclusion visit.

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