One-Year Postmarket eSCOPE Data Support Sapheon's VenaSeal Closure System

February 28, 2014—Sapheon, Inc. (Morrisville, NC) announced 1-year results from its European multicenter clinical study of the VenaSeal Sapheon closure system for the treatment of varicose veins caused by venous reflux disease. The postmarket eSCOPE (European Sapheon Closure System Observational Prospective) study was initiated in the fourth-quarter of 2011 after the device received European CE Mark approval.

According to the company, this single-arm, multicenter, postmarket study involves nine physicians at seven sites treating 70 patients from the United Kingdom, Germany, Denmark, and The Netherlands. All patients were treated without tumescent anesthesia or postprocedure compression stockings and will be followed for 3 years. All treatments were successful, and a closure rate of 92.9% was observed at 12 months (n = 66).

Prof. Thomas Proebstle, MD, of Mainz University, Germany, is Coprincipal Investigator of the study.

In Sapheon’s press release, Prof. Proebstle commented, “Cyanoacrylate embolization is an effective and durable solution to the problem of incompetent great saphenous veins. Long-term effectiveness is high. The elimination of the need for perivenous tumescent anesthesia and postinterventional compression stockings, along with the associated side effects, results in significantly improved treatment.”

VenaSeal is not commercially available in the United States, where it is under clinical investigation in the 1:1 randomized VeClose pivotal study to determine its safety and effectiveness compared to radiofrequency thermal ablation. The VeClose study is being conducted under a US Food and Drug Administration (FDA) investigational device exemption. The study, which was fully enrolled in September 2013, has clinical investigators at 10 United States sites for the treatment of 242 study patients.

In January 2014, Sapheon announced that it had submitted the second module of the premarket approval application for the VenaSeal Sapheon closure system to the FDA. On January 28, Sapheon announced that VenaSeal received approval from Health Canada.