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Clinical papers endorse VenaSealâ„¢ as a significant treatment for Varicose Veins

A number of recent academic papers have strongly endorsed VenaSeal™ as a significant treatment for Varicose Veins.

The first of these, was a Feasibility Study: which featured 2-year Follow-up Data. The study "TWO-YEAR FOLLOW-UP OF FIRST HUMAN USE OF CYANOACRYLATE ADHESIVE FOR TREATMENT OF SAPHENOUS VEIN INCOMPETENCE" by Almeida, J.I., Javier, J.J., Mackay, E.G., Bautista, C., Cher, D.J., Proebstle, T.M.  features in Phlebology. 2014 Apr 30. [Epub ahead of print]. The study found that the first-in-human use of VenaSeal to treat venous reflux disease in the GSV proved to be feasible, safe and effective without the need for perivenous tumescent anesthesia and post-procedure compression stockings. Initial clinical and anatomical results were durable over a follow-up period of 24 months.

The full article can be viewed at online at phl.sagepub.com. (full article)

The next featured 12 month data and was presented at the 15th Annual Meeting of the European Venous Forum in Paris in June. The paper, "12 MONTHS FOLLOW-UP OF THE EUROPEAN MULTICENTER STUDY ON CYANOACRYLATE EMBOLIZATION OF INCOMPETENT GREAT SAPHENOUS VEINS" by T. M. Proebstle found that Transcatheter endovenous CA adhesive for closure of insufficient GSVs proved to be feasible, safe and effective without the use of sedation, tumescent anesthesia or compression stockings. Side effects were mild, in particular paresthesia was not observed. Long-term effectiveness appears high, with no late failures between months 6 and 12.

The abstract is available here View Abstract

The final paper featured 3 month data from the US pivotal trial (non-inferiority to RF) and was also presented at the 15th Annual Meeting of the European Venous Forum. The paper "A RANDOMIZED, CONTROLLED STUDY COMPARING CYANOACRYLATE ADHESIVE EMBOLIZATION WITH RADIOFREQUENCY ABLATION FOR TREATMENT OF INCOMPETENT GREAT SAPHENOUS VEINS" by Nick Morrison found that Cyanoacrylate embolization (VS) as compared to radiofrequency ablation (RF) demonstrates similar closure at 3 months (non-inferiority p-value <0.0001). VCSS scores were significantly improved in the VS and RF groups, indicating the expected clinical response to treatment.

The safety and efficacy of cyanoacrylate embolization in the treatment of the incompetent GSVs observed at three months post-treatment will be followed by additional long-term assessments at Months 6, 12, 24, and 36.

The abstract is available here View Abstract.

If you would like more information about the VenaSeal™ Sapheon Closure System, please visit the venaseal website or contact PEI via email here. Alternatively, if you would like to know what physicians offer the treatment in your area please click here (Rep of Ireland) or here (Northern Ireland).
 

 

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