Objectives: To prove that the ELVeS® Radial® 2ring slim fiber (Biolitec AG, Wien, Austria) is safe and effective, with a reliable fiber durability.
Methods: 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.
Results: 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 80.7 cm. 98.3% occlusions were observed after 12 months. Clinical improvement was significant with reduced venous clinical severity scores at 1 month (1.7 ±1.9; < .0001) and 12 months (0.7 ±1.3; < .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.
Conclusions: 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.
Clinical Registration: The study protocol was registered in clinicaltrials.gov (NCT03810677).
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http://dx.doi.org/10.1177/02683555231193883 | DOI Listing |
Phlebology
December 2023
Archer Research CRO, Diepenbeek, Belgium.
Objectives: To prove that the ELVeS® Radial® 2ring slim fiber (Biolitec AG, Wien, Austria) is safe and effective, with a reliable fiber durability.
Methods: 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.
Objectives: The objective of this study was to evaluate the clinical efficacy of a two-step endovenous laser ablation (EVLA) protocol for treating long-reflux great saphenous veins (GSV) below the knee (BK) while preventing saphenous nerve injury.
Methods: A total of 370 legs with long-reflux to BK-GSV underwent EVLA using a Biolitec 1470 nm laser system and a radial 2-ring slim fiber. The above-knee GSV was ablated at 7 W (50-70 J/cm), and the BK-segment was ablated at 5 W (20-25 J/cm) in a two-step.
Phlebology
July 2023
Kumamoto Vascular Clinic, Kumamoto, Japan.
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