the last patient of the first Sonovein study in the United States has been treated

Theraclion announced on October 14, at the AVLS 2022 congress in New Orleans, Louisiana (United States), that all patients in the first Sonovein study in the United States had been treated.

A total of 20 patients were recruited in this clinical trial approved by the FDA (Food & Drug Administration) at the start of 2022. At the head of this clinical trial: Dr Steve Elias, principal investigator, Dr Nicos Labropoulos and Dr Antonios Gasparis , all three internationally recognized vein specialists, each with over 30 years of experience. Sonovein HD uses a robotic platform that integrates the best-in-class high-definition ultrasound imaging system, the MACH30 10-12Mhz, and high-intensity focused ultrasound to obliterate the source of venous reflux in a totally non-invasive way.

The first results were presented at the 36th annual meeting of the American Vein & Lymphatic Society (AVLS) on October 14. Dr. Elias pointed out that 19/20 (95%) of cases had no reflux after one week. The abolition of reflux is observed in 100% of patients at the end of the 3-month study observation period (10 veins out of 10). No adverse events were reported. All patients were treated without local or tumescent anesthesia. No post-intervention compression was used. Dr. Elias said during the congress that the Sonovein HD provided faster treatment than previous generations and that he “only needed his ultrasound pencil and gel” to treat his patients. Patients can therefore be treated and resume normal activity immediately.

Dr. Michel Nuta, Director of Clinical Affairs at Theraclion, said: “a 95% success rate including the learning curve is very encouraging and reflects the major clinical and technical developments behind Sonovein HD”.

The next step is the closure of this study and then the start of a full pivotal study for FDA review.

Leave a Comment