Advertisement

September 22, 2011

FDA Clears Covidien's ClosureFast 3-cm Endovenous Radiofrequency Catheter

September 23, 2011—Covidien (Mansfield, MA) announced 510(k) clearance from the US Food and Drug Administration for the ClosureFast 3-cm endovenous radiofrequency catheter to treat short refluxing vein segments in patients with varicose veins caused by chronic venous insufficiency. The 3-cm ClosureFast will be launched next month in the United States.

According to the company, the new ClosureFast catheter has a 3-cm heating element for the treatment of shorter refluxing vessels such as anterior accessory great saphenous, posterior accessory great saphenous, small saphenous, and intersaphenous veins. It uses the same radiofrequency segmental ablation technology as the ClosureFast catheter for the treatment of superficial veins reflux, allowing for controlled, even heating for consistent and reliable vein ablation in a 3-cm segment. The ClosureFast catheter demonstrated a 93% efficacy rate at 3 years and is shown to have statistically significant better patient outcomes compared to 980-nm endovenous laser, the company stated.

“With patient care being one of our highest priorities as physicians, treatments such as the ClosureFast catheter offer patients the latest advancements in medical technology,” commented Jennifer Heller, MD. “The new catheter, with ClosureFast technology, has the ability to treat venous reflux in shorter vein segments, providing patients with the potential for a fast recovery.”

Advertisement


September 23, 2011

Cook Medical's Zilver Vena Stent Approved and Launched in Europe

September 23, 2011

Cook Medical's Zilver Vena Stent Approved and Launched in Europe