November 13, 2014
VeClose Study Demonstrates Safety, Effectiveness of Covidien's VenaSeal Closure System
November 13, 2014—Covidien announced that the 6-month results of the VeClose pivotal study demonstrated the safety and effectiveness of the VenaSeal closure system in patients with chronic venous insufficiency having symptomatic reflux in the great saphenous vein. The results were presented at ACP 2014, the American College of Phlebology’s annual congress, in Phoenix, Arizona.
According to the company, the VenaSeal system is a minimally invasive procedure that uses a specially formulated medical adhesive to close the great saphenous vein. 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.
The VeClose randomized controlled noninferiority study compared the safety and effectiveness of the VenaSeal system to that of Covidien’s ClosureFast endovenous radiofrequency ablation catheter, which is designed to collapse and close enlarged leg veins. The trial enrolled 242 patients, of whom 108 were randomized to receive treatment with the VenaSeal system and 114 with the ClosureFast catheter. Twenty patients were enrolled as roll-in/training cases and treated with the VenaSeal system.
Covidien reported that the VeClose results showed outcomes for the VenaSeal system comparable with the excellent closure rates associated with the ClosureFast catheter and demonstrated noninferiority of the VenaSeal system. At 3 months, the complete closure of the great saphenous veins was achieved in more than 98.9% of patients treated with the VenaSeal system compared to 95.6% of patients treated with the ClosureFast catheter.
The closure rate at 6 months was 98.9% for the VenaSeal system and 94.3% for the ClosureFast catheter. Additionally, there were no significant differences in patient-reported pain during or at 3 days postprocedure between the groups.
Nick Morrison, MD, serves as co-national principal investigator for the VeClose study. In Covidien’s press release, Dr. Morrison commented, “The VenaSeal system is the latest innovation in the evolution of minimally invasive treatment options for chronic venous disorders. The 6-month results of the VeClose study showed high closure rates, comparable to radiofrequency ablation. I am excited about the possibility of offering this tumescent-free treatment option to patients.”
The company also reported that the eSCOPE (European Sapheon Closure System Observational Prospective) study demonstrated significant improvement in venous symptoms with a cumulative 12-month closure rate of 92.9%. Furthermore, the results demonstrated the VenaSeal system improved patients’ quality of life. Thomas Michael Proebstle, MD, et al published those results online ahead of print in Journal of Vascular Surgery: Venous and Lymphatic Disorders in October 2014.
Covidien advised that the VenaSeal system is currently approved in Australia, Canada, Europe, and Hong Kong. The VenaSeal closure system is not approved in the United States and is currently limited to investigational use.