Covidien announced the five-year results of the ClosureFast Long-Term European Multi-Center Study in patients with chronic venous insufficiency in December. The ClosureFast study was conducted prospectively at eight centres in Europe. The Venefit procedure (using the ClosureFast radiofrequency ablation catheter) was used to treat 295 lower limbs in 225 patients diagnosed with superficial venous reflux, the underlying cause of varicose veins and chronic venous insufficiency.
“The five-year final analysis from the ClosureFast Study shows sustained treatment success in anatomical and clinical categories and supports its leading position in endovenous vein treatment,” said Thomas Proebstle, Universitaets Hautklinik Heidelberg, Germany, who recently delivered the study results at the American College of Phlebology 26th Annual Congress.
This prospective, multicentre study enrolled 225 patients and treated 295 limbs at eight centres in Europe from April 2006 to June 2007. The study treated patients diagnosed with superficial venous reflux with the minimally invasive Venefit procedure using the ClosureFast radiofrequency ablation catheter.
Patients were evaluated following the procedure by duplex ultrasound imaging and clinical examination at three days, three months, six months and in yearly intervals up to five years. Of the 295 treated limbs, 233 (79%) were available for examination at five years. According to Kaplan-Meier analysis, at five-year follow-up, full occlusion of the treated vein was observed in 92% of patients (vs. 98% at one year). The vast majority (95%) of patients were free of pathological venous reflux (vs. 99% at one year).
The average Venous Clinical Severity Score improved from 3.9±2.1 before treatment to 1.3±1.7 at five years. In addition, only 14% of limbs were CEAP class 3 or higher at five years, while, at baseline, 48% of limbs were in the same category.
“This pivotal study provides substantial long-term data on relevant endpoints to help clinicians decide the appropriate treatment for their patients, thus defining Covidien’s commitment to a strong foundation of clinical research,” said Mark A Turco, chief medical officer, Vascular Therapies, Covidien.