Non-surgical, non invasive method to treat Breast Fibroadenoma by Focused Ultrasound System shows promising results.

courtesy: http://www.theraclion.com/

Theraclion announced results of a study evaluating the long-term assessment of breast fibroadenoma (benign tumor) volume reduction following treatment with the company’s Echopulse, a non-invasive treatment employing ultrasound-guided high-intensity focused ultrasound (HIFU).

Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound.

The study results were published online in the March 2017 issue of the Journal of Therapeutic Ultrasound.

20 patients with 26 Breast Fibroadenomas (BFAs) were recruited in the study. 19 BFAs received a single outpatient treatment session with Echopulse, while 7 fibroadenomas required a second session 6-9 months after the first initial session.

Patients were evaluated for Mean BFA volume, symptom relief and cosmetic appearance after the procedure.

All the patients were extremely satisfied by the treatment results. Mean BFA volume decreased by 77.32 percent after a single procedure and by 90.47 percent after two procedures at 24 months follow up.

Patients did not experience any serious side effect expect mild pain and tenderness at the treated site. Study did not report any regrowth of the tumor. They reported 100% satisfaction for the cosmetic appearance and 95% satisfaction for relieving the symptoms.

Breast fibroadenomas (FA) are the most prevalent benign tumours, accounting for up to 70% of benign breast lesions.

Currently, the accepted definitive treatment of FA is breast-conserving surgery which removes the FA entirely with a subsequent tissue volume defect and risk of complications as bleeding, seroma formation and chronic incisional pain.

“Our results show the long-term efficacy and safety of US-guided HIFU generated by Theraclion’s Echopulse in patients with breast fibroadenomas. US-guided HIFU is definitely an effective non-invasive alternative to surgery enabling more than 90 percent volume reduction without re-growth or serious adverse events” said Roussanka Kovatcheva M.D., professor of endocrinology at the University Hospital of Endocrinology of Sofia, Bulgaria, and Principal Investigator.

 Echopulse®, based on a unique ultrasound technology, combining focused ultrasound therapy (HIFU) and real-time ultrasound monitoring. This dual functionality allows precise, individualized, non-invasive and ambulatory treatment of breast adenofibromas and benign thyroid nodules.

The main components are: ● Visualization and processing unit (VTU) ● Integrated ultrasound system ● Arms and scanning motors ● Coupling and cooling system ● Patient motion detector ● Touch user interface.

Echopulse have already won the CE Mark for regulatory approval in the European Union for non-invasive ablation of breast fibroadenomas and thyroid nodules.

courtesy: http://www.theraclion.com/

The first patient in US was recently treated as a part of U.S. pivotal clinical trial evaluating the safety and efficacy of the company’s Echopulse. The trial is expected to enroll 100 patients across 4 sites in US and 1 site in Germany.

“High intensity focused ultrasound (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 principal investigator Dr. David Brenin. 

The full text of the article in Journal of Therapeutic Ultrasound can be accessed here.