Three-Month Data Published on VenaSeal Closure System for Incompetent GSVs

April 1, 2015—Nick Morrison, MD, et al reported early results of the randomized VeCLOSE pivotal trial of cyanoacrylate embolization (CAE) with the VenaSeal closure system (Medtronic) versus radiofrequency ablation (RFA) for the treatment of symptomatic incompetent great saphenous veins (GSVs) in the Journal of Vascular Surgery (2015;61:985–994).

The VenaSeal system is a minimally invasive procedure that uses a specially formulated medical adhesive to close the GSV. The VenaSeal system also eliminates the need for surgery, thermal ablation, and tumescent anesthesia.

VenaSeal was developed by Sapheon, Inc., which was acquired by Covidien in August 2014. Covidien was acquired by Medtronic in January 2015. On February 20, Medtronic announced US Food and Drug Administration approval of the VenaSeal system for the treatment of symptomatic lower extremity varicose veins through endovascular embolization with coaptation.

The VeCLOSE investigators concluded that CAE with the VenaSeal system, which does not require tumescent anesthesia and is associated with less postprocedure ecchymosis, was proven to be noninferior to RFA for the treatment of incompetent GSVs at 3 months after the procedure. Both treatment methods showed good safety profiles. 

The background of the study noted that thermal ablation of incompetent saphenous veins is highly effective, but all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia, involving multiple needle punctures along the course of the target vein. The study sought to support preliminary evidence suggesting that CAE may be effective in the treatment of incompetent GSVs. 

In the study, 222 patients with symptomatic GSV incompetence were randomly assigned to receive either CAE (n = 108) with the VenaSeal system or RFA (n = 114) with the ClosureFast system (Covidien, now Medtronic plc). After discharge, patients returned to the clinic on day 3 and again at months 1 and 3.

The study's primary endpoint was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory. Secondary endpoints included patient-reported pain during vein treatment and extent of ecchymosis at day 3. Additional assessments included general and disease-specific quality-of-life surveys and adverse event rates.

All patients received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary endpoint analyses showed evidence to support the study's noninferiority hypothesis and some of these analyses supported a trend toward superiority. Pain experienced during the procedure was mild and similar between treatment groups. At day 3, less ecchymosis in the treated region was present after CAE compared with RFA. Other adverse events occurred at a similar rate between groups and were generally mild and well tolerated.

In November, the 6-month VeCLOSE study results were presented at ACP 2014, the American College of Phlebology’s annual congress in Phoenix, Arizona. The data demonstrated the safety and effectiveness of the VenaSeal closure system in patients with chronic venous insufficiency having symptomatic reflux in the GSV.