Ultrasound-Guided HIFU Used for the Treatment of Breast Fibroadenomas

A new noninvasive therapeutic application using ultrasound-guided, high-intensity focused ultrasound (HIFU) is currently being employed for a specifically localized ablation with no skin damage. The ultrasound waves are focused on a small area where the rise in temperature leads to tissue necrosis. This precision avoids injuring healthy tissues around the lesion. The echotherapy is a technique that enables clinicians to visualize and simultaneously treat a tumor such as fibroadenoma with no incision or scar.

Theraclion (Paris, France), a specialist in cutting-edge medical technology that develops echotherapy technology that uses HIFU, has received the CE marking approval for the noninvasive treatment of breast fibroadenomas, a first for this indication.

“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 noninvasive outpatient treatment without general anesthesia which puts an end to the embarrassment and anxiety triggered by this kind of tumor. Noninvasive 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 noninvasive surgery centers based on our resulting echotherapy solution within leading hospitals and clinics. Other tumors beside breast fibroadenomas will be treated in a noninvasive manner in the near future,” said Jean-Yves Burel, CEO of Theraclion.

Fibroadenoma is the most widely spread breast benign tumor, with 10% of women risk developing it in their lifetime. It represents more than half of breast biopsies. This disorder hits women of all ages but is a lot more frequent with women under 30. Estimates show that 50,000 fibroadenoma tumors are detected each year in France, with 320,000 in Europe and 640,000 in the United States.

“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 six months. EchoPulse could represent an interesting alternative to classical surgery,” added Dr. Marc Abehsera from the medical imaging service at the American Hospital of Paris.

“It is interesting [to be able to] participate in the assessment of echotherapy in breast fibroadenoma in the French trial. We are hoping to participate in a multicenter trial that will measure the effects of this type of treatment in breast cancer,” stated Dr. Edouard Poncelet from the woman imaging service at the Valenciennes Hospital Center).

A clinical trial on 40 patients has shown the efficiency and the excellent tolerance of echotherapy for this type of pathology. Currently, 48 fibroadenomas have been treated in three French centers (Lille Jeanne de Flandres Hospital, the Valenciennes Hospital, and the American Hospital of Paris) and one center in Bulgaria (the University Hospital of Sofia), with considerable volume reductions accompanied by the resolution of symptoms.

EchoPulse, the medical device developed by Theraclion, uses ultrasound imaging as a targeting system and HIFU for tissue necrosis, thereby eliminating the need for patients to undergo a surgical procedure. EchoPulse is unique as it combines in the same device an imaging monitoring and treatment system while remaining compact and mobile. In addition to its ergonomic benefits, it provides excellent image quality, a millimetric accuracy of wave shots, and an integrated cooling system for the patient’s safety. The benefits offered by EchoPulse are beneficial for the patients (noninvasive, scarless, and mobile treatment, conscious sedation) but also for the practitioners (fast, effective, and harmless) and hospital centers (efficient, less hospitalization costs, one device for several pathologies).

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