Covidien (NYSE:COV) unveiled the results of its ClosureFast Long-Term European Multi-Center Study, which evaluated 5-year outcomes of the medical device maker’s radiofrequency ablation therapy in patients with chronic venous insufficiency.
The study, which was conducted at 8 centers in Europe from April 2006 to June 2007, used the company’s ClosureFast ablation catheter to treat 295 lower limbs in 225 patients diagnosed with superficial venous reflux, according to the press release.
Superficial venous reflux is the underlying cause of varicose veins and chronic venous insufficiency, which impacts over 30 million Americans in the U.S. Varicose veins may advance to CVI, a condition which may result in lower leg pain, skin damage, and leg ulcerations, according to Covidien.
"This pivotal study provides substantial long-term data on relevant end-points to help clinicians decide the appropriate treatment for their patients, thus defining Covidien’s commitment to a strong foundation of clinical research," vascular therapies chief medical officer Mark Turco said in prepared remarks.
The study shows that among the 233 patients available for examination at 5 years 92% of them experienced full occlusion of the treated vein and 95% were free of pathological venous reflux, according to the press release.
At the American College of Phlebology 26th Annual Congress, Dr. Thomas Proebstle of Universitaets Hautklinik Heidelberg in Germany said the 5-year final analysis demonstrated sustained treatment success in anatomical and clinical categories and supports its leading position in endovenous vein treatment.
Massachusetts medical device company Covidien recently acquired drug-coated balloon maker CV Ingenuity, planning to put at least $50 million toward R&D for the company’s technologies.