Durability and efficacy of the ELVeS® Radial® 2ring slim fiber for multiple ablations.

Abstract

To prove that the ELVeS® Radial® 2ring slim fiber (Biolitec AG, Wien, Austria) is safe and effective, with a reliable fiber durability. This prospective, non-randomized, registry recruited patients with venous incompetence of the great saphenous vein, with or without concomitant incompetence of the small, anterior accessory and posterior accessory saphenous veins. Anatomic success, clinical success and pain were assessed. 150 patients (410 veins) underwent endovenous laser ablation (EVLA). Mean number of veins treated was 2.7 (1-7) with a mean total length of 80.7cm. 98.3% occlusions were observed after 12months. Clinical improvement was significant with reduced venous clinical severity scores at 1 month (1.7 ±1.9; p < .0001) and 12 months (0.7 ±1.3; p < .0001) versus pre-operation (4.4 ± 2.2). Mean pain level after 1-week was 5.8/100. No major surgery- or device-related complications occurred. 1470-nm EVLA with the 2ring slim fiber is a highly effective treatment option well tolerated by patients. Despite intensive use, fiber integrity was preserved. The study protocol was registered in clinicaltrials.gov (NCT03810677).