(NYSE:COV), a leading global provider of healthcare products, today announced the five-year results of the ClosureFast™ Long-Term European Multi-Center Study in patients with Chronic Venous Insufficiency (CVI). This study evaluates the five-year outcomes of a minimally invasive endovascular therapy for treatment of CVI.
Covidien's ClosureFast catheter was successfully used in the European Multi-Center Study in patients with lower limb venous disease (Photo: Business Wire)
The ClosureFast Study was conducted prospectively at eight centers 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 CVI. This progressive medical condition affects the veins in the leg and compromises their ability to carry blood back to the heart. This is a worldwide issue and, in fact, impacts over 30 million Americans in the United States alone.
If left untreated, varicose veins can advance to CVI, which, in severe cases, may result in lower leg pain, skin damage, and leg ulcerations.
"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, MD, Universitaets Hautklinik Heidelberg, Germany, who recently delivered the study results at the American College of Phlebology 26
ClosureFast Study Design and Five-Year Results
This prospective, multi-center study enrolled 225 patients and treated 295 limbs at eight centers 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.