VNUS Gets FDA Clearance For Its Closure System

VNUS Medical Technologies Inc. (Sunnyvale, CA) has received clearance from FDA to market its Closure system for use in the endovascular coagulation of blood vessels in patients with superficial vein reflux.

The company has developed a line of proprietary, catheter-based products that treat the primary causes of venous insufficiency—venous reflux. The VNUS Closure system comprises an endovenous catheter, a custom radiofrequency generator, and accessory products. The Closure catheter utilizes collapsible electrodes placed in contact with the vein wall to deliver RF energy to the vein wall. The energy induces the vein to shrink and occlude, thereby abolishing venous reflux. Two models of Closure catheters have been developed, a 5F catheter with electrodes that expand to 8 mm, and an 8F catheter with electrodes that expand to 12 mm.

VNUS has previously received CE marks for the Closure Catheter and RF Generator and has been marketing products in Europe since 1998.