Theraclion has announced the results of the first Sonovein trial in the USA, which the company describes as a “major milestone” towards receiving US Food and Drug Administration (FDA) approval and accessing the US varicose veins market.
Theraclion reports a 100% feasibility result—the primary endpoint of the trial. It notes also that patients did not experience any serious adverse event, and that abolition of venous reflux, as measured by duplex ultrasound, was achieved in 95% of cases.
A total of 20 patients were enrolled in this clinical trial, which was approved by the FDA in early 2022. The study compliance was 100%, meaning all 80 visits were completed and timely and none lost to follow-up or missed visits, a press release details.
Steve Elias (Englewood Health Network, Englewood, USA), Antonios Gasparis and Nicos Labropoulos (both Stony Brook Medicine, Stony Brook, USA) conducted the trial.
Elias commented: “I am happy to have finished the first FDA-approved trial with Sonovein in the USA. More importantly, the results are as good—if not a little bit better—than some of the results with the more traditional technologies. Ninety-five per cent of patients had a successful healing of the abnormal vein. We treat people who have abnormal veins, and not just the veins. Most important, all patients felt better. Sonovein really is the next evolution of a completely non-invasive, transcutaneous way of treating vein diseases. We look forward to being able to offer this to our patients.”
Theraclion’s chief medical officer and Veins vice president Michel Nuta said: “These very robust results generated by first-class [key opinion leaders] are the launchpad for our pivotal, multicentre FDA study, which will start shortly. The USA patients are needing the access to an extra corporeal incision-free varicose veins treatment, without catheters or foreign chemical products insertion.”