For Healthcare Professionals

Clinical Evidence

Peer-reviewed outcomes, transparent safety data and current guideline context for the VenaBlock® cyanoacrylate vein closure system.

Guideline context

The European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines state that for patients with great saphenous vein incompetence requiring treatment, cyanoacrylate adhesive closure (CAC) should be considered when a non-thermal, non-tumescent technique is preferred — a Class IIa recommendation with Level A evidence.[3] Endovenous ablation remains the guideline-recommended first-choice treatment for saphenous incompetence, in preference to open surgery and ultrasound-guided foam sclerotherapy.[3]

ESVS 2022, Recommendation 30: “For patients with great saphenous vein incompetence requiring treatment, cyanoacrylate adhesive closure should be considered when a non-thermal non-tumescent technique is preferred.” — Class IIa, Level A.[3]

Key VenaBlock® studies

Large single-device cohort · Vascular, 2018 · n = 538

A new n-butyl-2-cyanoacrylate glue ablation catheter with application guiding light for venous insufficiency: twelve-month results[1]

538 patients with great saphenous vein incompetence were treated with the VenaBlock® system without tumescent anaesthesia and without mandatory compression stockings. Endpoints included procedural success, occlusion at 12 months, the Venous Clinical Severity Score (VCSS) and the Aberdeen Varicose Vein Questionnaire (AVVQ).

100%
Procedural success
99.4%
KM occlusion, 12 mo
5.43 → 0.6
VCSS improvement
18.32 → 4.61
AVVQ improvement

No skin pigmentation, paresthesia, deep vein thrombosis or pulmonary embolism was observed in this cohort (p < 0.0001 for VCSS and AVVQ improvements).

Prospective registry · Phlebology, 2021 · 29 patients / 39 limbs · NCT04339075

The RIVIERA trial — six-month results of the VenaBlock® Vein Sealing System in a multi-ethnic Asian cohort (Singapore General Hospital)[2]

Single-arm prospective study of symptomatic C2–C6 patients with truncal reflux > 0.5 s. Compression stockings were not used post-operatively, and veins up to 12 mm in diameter were included.

100%
Occlusion, 2 wk & 3 mo
97.2%
Occlusion, 6 mo
23.4 min
Mean device time
5.2 → 2.1
rVCSS at 6 mo

Quality-of-life measures improved significantly at 6 months: AVVQ 18.1 → 7.9 (p = .007) and CIVIQ 18.6 → 4.5 (p < .001). Reported adverse events: puncture-site infection in 5/29 patients (17.2%, three requiring drainage) and phlebitis in 3/29 (7.7%). The authors recommend longer follow-up to assess durability and puncture-site care.

Interpreting the data — limitations

  • The 538-patient cohort is retrospective and single-centre; the RIVIERA trial is single-arm without a comparator group.
  • Cyanoacrylate hypersensitivity reactions are reported in the literature for the CAC class (approximately 6–7% in pooled guideline data); patient screening is advised.[3]
  • Long-term (>5-year) durability data for the CAC class continue to accumulate; follow-up per local protocol is recommended.

References

  1. Eroglu E, et al. A new n-butyl-2-cyanoacrylate glue ablation catheter with application guiding light for venous insufficiency: twelve-month results. Vascular. 2018;26(5):547–555. DOI: 10.1177/1708538118770548
  2. Linn YL, Yap CJQ, Soon SXY, et al. Registry to investigate the efficacy and safety of the VenaBlock© VeIn SEaling system for VaRicose veins in SingApore — six months results of the RIVIERA trial. Phlebology. 2021;36(10):816–826. DOI: 10.1177/02683555211025181 · ClinicalTrials.gov: NCT04339075
  3. De Maeseneer MG, Kakkos SK, et al. European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022;63(2):184–267. DOI: 10.1016/j.ejvs.2021.12.024
Varicose Vein Treatment GuideDevice & TechnologyINVAMED Evidence Library

This page summarises published literature for healthcare professionals and interested readers. It is not medical advice and does not replace the Instructions for Use. Results observed in clinical studies; individual outcomes may vary. Product availability and indications vary by country.