Covidien plc points us at six-month results of the VeClose pivotal study, presented at American College of Phlebology Annual Congress (ACP 2014) in Phoenix, Arizona this week. The results demonstrated the safety and effectiveness of the VenaSeal™ closure system in patients with chronic venous insufficiency (CVI) having symptomatic reflux in the great saphenous vein.
CVI is a progressive, sometimes debilitating medical condition. It occurs when valves in the veins of the lower leg no longer function to push blood back to the heart. This allows blood to flow backward, or reflux resulting in enlarged, or varicose, veins. If left untreated, the condition can progress and, in severe cases, can result in lifestyle-limiting lower leg pain, swelling, skin damage and ulcerations.
The VenaSeal™ system comprises a minimally invasive procedure that uses a specially formulated medical adhesive to close the great saphenous vein. Additionally, the VenaSeal™ system aims to eliminate the need for surgery, thermal ablation and tumescent anesthesia. Despite having CE mark as long ago as 2011, it remains currently limited to investigational use in the U.S.
Back in August Covidien acquired vascular device start-up Sapheon, Inc., developer of the VenaSeal closure system.
The VeClose study compares VenaSeal with the radiofrequency ablation procedure performed using Covidien’s own ClosureFast™ catheter, an endovenous catheter designed to collapse and close enlarged leg veins. VeClose is a randomized controlled non-inferiority study, undertaken as part of a modular PMA in the U.S. about which we’ve written before.
Two hundred and forty-two patients were enrolled in the trial, of which 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. The results showed outcomes for the VenaSeal™ system comparable with closure rates associated with the ClosureFast™ catheter and demonstrated non-inferiority of the VenaSeal™ system:
- At three months, the complete closure of the great saphenous veins achieved in more than 98.9 percent of patients treated with the VenaSeal™ system compared to 95.6 percent of patients treated with the ClosureFast™ catheter.
- The closure rate at six months was 98.9 percent and 94.3 percent for the VenaSeal™ system and the ClosureFast™ catheter, respectively.
- Additionally, there were no significant differences in patient reported pain during or at three days post procedure between the groups.
The system is supported further by an October 2014 publication in the Journal of Vascular Surgery published results from the European Sapheon™ Closure System Observational ProspectivE (eSCOPE) study. Results demonstrated significant improvement in venous symptoms with a cumulative 12 month closure rate of 92.9 percent together with improved patients’ quality of life.
“The VenaSeal™ system is the latest innovation in the evolution of minimally invasive treatment options for chronic venous disorders,” said Dr. Nick Morrison, co-National Principal Investigator for the VeClose study. “The six-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 breadth of Covidien’s CVI portfolio provides patients and physicians the opportunity to have two safe and minimally invasive treatment options supported by leading clinical evidence,” said Dr. Mark Turco, chief medical officer, Vascular Therapies, Covidien. “The results of the VeClose and eSCOPE studies clearly demonstrate the effectiveness and safety of the VenaSeal™ system along with the previously reported long term data available for the ClosureFast™ catheter.”
Source: Covidien, plc., Business Wire