Sapheon Completes PMA Application for VenaSeal Closure System

January 7, 2014—Sapheon Inc. (Morrisville, NC) announced that it has submitted the second module of the company’s premarket approval (PMA) application for the VenaSeal Sapheon closure system to the US Food and Drug Administration (FDA). The first module was submitted in September 2013, reviewed by the FDA, and accepted without deficiencies within a single review cycle. The second module submission was completed on December 18, 2013.

According to the company, VenaSeal is a minimally invasive, single-use kit intended for the treatment of venous reflux disease. VenaSeal is currently under clinical investigation in the 1:1 randomized pivotal VeClose study to determine its safety and effectiveness compared to radiofrequency thermal ablation. 

The VeClose study, which is being conducted under an FDA-approved investigational device exemption, includes clinical investigators at 10 sites in the United States for the treatment of 242 study patients and was fully enrolled in September 2013. The company expects the 3-month assessments of patients enrolled in the VeClose study to be completed in January 2014 and the study’s primary efficacy endpoint of vein closure, as adjudicated by an independent core laboratory, to be reported shortly thereafter.

Sapheon advised that it is also sponsoring two other VenaSeal studies. In September 2012, the company completed enrollment in a 70-patient European postmarket evaluation at seven sites in Germany, the United Kingdom, the Netherlands, and Denmark. In July 2011, the company completed enrollment in a 38-patient feasibility study conducted in the Dominican Republic. Sapheon will continue to follow the patients in these two studies for 3 years. The clinical data collected in these studies will be used to support the PMA application, as well as reimbursement in markets outside the United States.

The VenaSeal Sapheon closure system received CE Mark approval in September 2011 and has been used to treat veins in patients without tumescent anesthesia or postprocedure compression hose therapy. The VenaSeal Sapheon closure system is currently limited to investigational use in the United States.