Echotherapy Option Addresses Breast Fibroadenomas

An innovative system uses high intensity focused ultrasound (HIFU) for the non-invasive treatment of breast fibroadenomas.

The Theraclion EchoPulse device is based on ultrasound both for the image-guided targeting system and for the delivery of HIFU for tissue necrosis. The system includes an ultrasonic transducer, an amplifier, a visualization and treatment unit (VTU), and an interchangeable cooling system (TH-Kit), which ensures both cooling and coupling functions. The EchoPulse is designed to provide optimal image quality, a milimetric range accuracy of wave shots, and step-by-step procedure control via a touch screen monitor.

The VTU head includes an ultrasound transducer for real-time monitoring of the target area, an HIFU emission device used for treatment, an articulated arm for easy positioning on the treatment area, and a motorized head which is can perform not only sagittal and transverse slices, but also micro-movements. Other advantages offered by the system are non-invasive, scarless treatment and conscious sedation for the patient; fast, efficient, and harmless procedures for practitioners; and lower costs of hospitalization for medical centers.

“HIFU technology is exciting because it has the potential to provide patients with an alternative to surgery, avoiding a scar, with minimal interruption in their normal daily activity,” said David Brenin, MD, chief of breast surgery at the University of Virginia, and principal investigator of the U.S. trial for the Echopulse. “An ultrasound transducer generates the energy over a broad surface area and focuses it underneath the skin. At the focus point of the energy, the tissue is heated up to about 60 degrees celsius, and there’s also a physical disruption that occurs from the sound energy itself.”

“We believe that patients are searching for alternatives to invasive surgery that are outpatient, of short duration, generate minimal or no post-treatment pain, and no scarring,” said David Caumartin, CEO of Theraclion. “There are approximately 400 thousand surgeries to remove breast fibroadenomas in the United States each year. This clinical trial is a significant step toward bringing our Echopulse echotherapy to U.S. patients.”

Fibroadenoma is the most widely spread breast benign tumor, with as much as 10% of women at risk of developing it in their lifetime; it also represents more than half of breast biopsies. It affects women of all ages, but is a lot more frequent with women under 30. The pathology is often found during a medical examination or by self-palpation, and radiologic images using mammography and ultrasound are used to confirm the diagnosis. In some cases, a micro biopsy is necessary to confirm its benign nature.