Study results were published in the March 2017 issue of the Journal of Therapeutic Ultrasound, the French company said.
The 20 patient study examined the use of the Echopulse system, an ultrasound-guided high-intensity focused ultrasound device, in reducing the volume of 26 breast fibroadenomas, or benign tumors.
Data indicated that mean BFA volume was reduced by 77.32% after a single procedure and 90.47% after 2 procedures at 2 years.
No cases of re-growth of treated lesions were observed at 2 years, and treatment was well tolerated regardless of the number of sessions performed, researchers said. No serious side effects were observed.
“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% volume reduction without re-growth or serious adverse events,” principal investigator Dr. Roussanka Kovatcheva of Sofia, Bulgaria’s University Hospital of Endocrinology said in a prepared statement.
“The results of this trial provide validation and confirmation of the remarkable and enduring effect of the Echopulse treatment for the breast fibroadenoma indication. In addition, for the first time, results related to the incremental efficacy of a second echotherapy session, with absence of rebound or serious adverse effects, were assessed at a significant follow-up period of two years. We are continuing our clinical research programs, including a 100-patient trial in the U.S., for reinforcing the status of Echopulse as a proven and patient friendly standard of care,” Theraclion chief medical officer Dr. Michel Nuta said in a prepared statement.