Key Points
- Theraclion has received US FDA clearance to begin a new pivotal clinical trial testing the Sonovein® device for the treatment of primary insufficiency of great saphenous veins.
- The multicenter study, called VEINRESET, will take place at four centers in the US and Europe.
Update: Theraclion announced that the first patients were treated in this trial at Englewood Health in New Jersey in October 2023. Martin Deterre, the company’s chief executive officer, commented, “These first patients treated in the pivotal study demonstrate the progress made by the Theraclion team, in a timeline perfectly aligned with our defined strategic roadmap. Enrollment is expected to take several months, with the ultimate goal of US market approval by early 2026.” Read the Press Release.
Those interested in learning more or potentially participating in this trial should contact Steven Elias, MD, at (201) 894-3599 or steven.elias@ehmchealth.org.
Theraclion has announced that it has received US Food and Drug Administration (FDA) clearance to begin a new pivotal clinical trial in the US and at several sites in Europe. The multicenter study, called VEINRESET, will take place at four centers to test the company’s Sonovein® device for the treatment of primary insufficiency of great saphenous veins.
The Sonovein® device, which is the first robotic solution for a 100% noninvasive echotherapy treatment of varicose veins, uses ultrasound guidance. The device earned the CE Mark in Europe in 2019.
“This is an important milestone in a process that will ultimately make available for the US patients the only extra corporeal, catheter free, and chemical free method for treating varicose veins,” said Michel Nuta, MD, Theraclion’s Vice President of Veins and Chief Medical Officer. “The SONOVEIN device is already a game-changer in varicose veins therapy, and we are exciting about the forthcoming implementation of artificial intelligence and improved robotics. Based on our results in Europe and in Asia, we are strong believers that the high-intensity focused ultrasound approach represents the future of chronic vein insufficiency treatment.”
Leading the US cohort is principal investigator Steven Elias, MD, director of the Center for Vein Disease at Englewood Hospital, New Jersey, and a Fellow of the American Board of Venous and Lymphatic Medicine and of the American College of Surgeons.
The remaining participating sites will be announced in the coming months, and treatments are planned to begin later this year.
This trial comes on the heels of an initial feasibility study that was performed in the US and completed in January. Theraclion reports that the results from that 20-participant trial were positive, and the company presented data from the study at the American Venous Forum and the New York Vein Symposium. A publication is forthcoming.