Non Invasive Ultrasound Therapy For Breast Fibroadenomas A Reality As Ultrasound Device Gains CE Mark

In short

Paris-based ultrasound therapy specialist, Theraclion, has gained CE mark approval for its non-invasive treatment of breast fibroadenomas, a first in this indication. The company expects this treatment to benefit thousands of women.


Fibroadenoma is the most widely spread breast benign tumor as 10% of women risk developing it in their lifetime. According to estimates, 640,000 fibroadenoma tumors are diagnosed each year in the U.S.

Echotherapy is a new non-invasive therapeutic approach with ultrasound-guided focused ultrasound, in which high intensity focused ultrasounds (10,000 times higher than normal ones) are used for a specifically localised ablation with no skin damage. Ultrasound energy is focused on a small area where the temperature rise leads to tissue necrosis. This precise targeting is said to avoid harming healthy tissues around the lesion.

EchoPulse, the medical device developed by Theraclion uses HIFU (High Intensity Focused Ultrasounds). EchoPulse uses ultrasound imaging as a targeting system and high intensity focused ultrasounds for tissue necrosis, thus preventing patients to undergo a surgical procedure.

EchoPulse uniquely combines image monitoring and treatment system in one compact and mobile device. In addition to its ergonomic advantage, Theraclion says it offers excellent image quality, millimetric accuracy of wave shots and an integrated cooling system for patient safety.
Physician comments

Dr Marc Abehsera from the medical imaging service at the American Hospital of Paris said; “I used the EchoPulse to treat 11 patients during a clinical trial at the American Hospital of Paris from January to October 2012. The results from this technique are encouraging with a 60% volume reduction of fibroadenoma in an average period of 6 months. EchoPulse could represent an interesting alternative to classical surgery”

Company comments

“The CE marking widens the use of our technology in the major area of breast fibroadenoma. Our technology can now be offered to all women suffering from this pathology in Europe. They can benefit from a non-invasive outpatient treatment without general anesthesia which puts an end to the embarrassment and anxiety triggered by this kind of tumor.Non-invasive focused ultrasound surgery guided by real-time ultrasound imaging is consistent with the logic of developing lesser invasive treatments and a reduction of health costs. This market authorization in Europe will allow us to grow by creating non-invasive surgery centers based on our resulting echotherapy solution within leading hospitals and clinics. Other tumors beside breast fibroadenomas will be treated in a non-invasive manner in the near future” says Jean-Yves Burel, CEO of Theraclion.

Source: Thercalion