Theraclion announced at the American Vein and Lymphatic Society (AVLS) 2022 annual meeting (13–16 October, New Orleans, USA) that the final patient has been enrolled and treated in the first US study of the company’s Sonovein solution for varicose veins.
A company press release notes that 20 patients in total have been enrolled in this US Food and Drug Administration (FDA)-approved clinical trial. Principal investigator Steve Elias (Englewood Health Network, Englewood, USA) conducted the trial alongside Nicos Labropoulos (Stony Brook Hospital, Stony Brook, USA) and Antonios Gasparis (Stony Brook University, New York, USA).
According to Theraclion, Sonovein HD utilises a robotic platform that integrates high-definition MACH30 10-12Mhz ultrasound imaging system with high intensity focused ultrasound to obliterate the source of venous reflux non-invasively.
At AVLS, Elias highlighted that 19/20 (95%) cases had no reflux at the one-week interval, adding that 10/10 patients had no reflux at the three-month interval that marked the completion of the study. The press release adds that there were no reported adverse events, all patients were treated without local or tumescent anaesthesia, and no post-procedure compression was utilised.
Elias shared during the congress that Sonovein HD enabled faster treatment than previous generations and that he “only needed his pencil and his ultrasound gel” to treat his patients. He also stated that all treated patients would recommend it to others: “This highlights that patients can be treated sitting in an exam chair and return to normal activity immediately.”
Michel Nuta, chief medical officer at Theraclion, said: “A 95% success rate, taking the learning curve into account, is very encouraging and reflects well the great clinical and technical developments behind Sonovein HD.”
Theraclion states that, following the upcoming closure of this clinical trial, a full pivotal study for FDA review should take place next.