Key Points
- Researchers in Spain reported encouraging results one year after using Theraclion’s SONOVEIN focused ultrasound device to treat varicose veins.
- The desired outcome, vein occlusion, which was 85% to 96% after treatment, was only slightly decreased at twelve months.
A new study published in Phlebology: The Journal of Venous Disease reports encouraging one-year outcomes for using Theraclion’s SONOVEIN® focused ultrasound device to treat superficial venous insufficiency (SVI), a leading cause of varicose veins.
SVI occurs when valves in the superficial veins of the legs fail to close properly, allowing blood to pool. This can lead to varicose veins, swelling, discomfort, and – in advanced cases – skin changes or ulcers. Current treatment options, such as endovenous ablation and sclerotherapy, are effective but involve needles, catheters, or other invasive access. In contrast, SONOVEIN delivers focused ultrasound energy from outside the body to precisely heat and close incompetent veins under real-time ultrasound guidance.
In this observational retrospective study, Rubén Rodríguez Carvajal, MBBS, and colleagues at the International Vascular and Endovascular Institute (IVEI) in Málaga, Spain, reviewed 102 patients who underwent SONOVEIN treatment at their institution. In total, 164 veins were treated. Patients were assessed by clinical exam and ultrasound at 15 days, 3 months, 6 months, and 12 months after treatment. Each patient’s venous disease was rated according to the American Venous Forum’s clinical, etiological, anatomical, and pathophysiological (or CEAP) classification system and venous clinical severity score (or VCSS).
The primary endpoint was vein occlusion rate, and secondary endpoints were shrinkage, absence of reflux, clinical improvement, and treatment-related complications. The data are reported in ranges, because the investigators subdivided the veins into three different types (saphenous trunks, perforator veins, and others).
Results indicated that the desired outcome, vein occlusion, which was measured to be 85% to 96% after treatment, was only slightly decreased to 85% to 90% twelve months later. Furthermore, no major adverse events were reported through 12 months. The study also determined that the initial reduction in reflux of 85% to 96% yielded 85% to 90% at twelve months. For reflux-free rate, the range of 85% to 96% after treatment was slightly smaller, from 85% to 93%, at twelve months. Vein shrinkage ranged from 96% to 97% after the treatment and was 94% to 97% at twelve months.
The authors suggest that Theraclion’s robotic SONOVEIN device should be competitive with established varicose vein treatments while offering the advantage of being noninvasive. Patients could benefit from shorter recovery times and fewer complications, particularly if they are not candidates for invasive procedures. Larger studies with longer follow-up are needed to confirm the long-term effectiveness and to refine treatment protocols.