A first-in-human study assessing the safety and efficacy of a novel device for ultrasound-guided percutaneous occlusion of the great saphenous (GSV), small saphenous (SSV) and perforator veins—used in association with foam sclerotherapy—demonstrated a 100% technical success rate and durable occlusion rates of 92.3% at six and 94.1% at 12 months, respectively, in the GSV and SSV, according to investigators. Additionally, rates of perforator occlusion were 84% at six and 90% at 12 months.
Data from the non-randomised, prospective, single-centre evaluation, carried out among 28 patients with varicose veins in Tirana, Albania, were presented today at The VEINS 2025 (1–2 November; Las Vegas, USA) by Steve Elias (Englewood Hospital and Medical Center, Englewood, USA).
“All target vessels evaluated with duplex ultrasound were occluded at the end of the procedure. Perforator veins were successfully treated,” explained Elias. There were no device-related adverse events and no serious adverse events, he reported. “One subfascial venous thrombosis of the calf was found in one patient at one-week follow-up and resolved with prolonged heparin treatment after 10 days,” he told The VEINS meeting. Patients also reported significant improvement in quality of life.
“The data confirms the safety and feasibility of this new device for the percutaneous occlusion of superficial veins in combination with foam sclerotherapy. Average time to deploy the device was 3 minutes, with an average overall procedure time comparable to the current modalities,” he concluded. “The use of an ultrasound-guided percutaneous device for junctional occlusion of the GSV in combination with foam sclerotherapy can be a viable alternative to existing thermal and non-thermal methods.”
Further studies with a next-generation device and comparative studies are planned as the company behind the technology seek US Food and Drug Administration approval, Elias added.
