InterVene’s BlueLeaf Endovenous Valve System Designated an FDA Breakthrough Device

South San Francisco, Calif.-based InterVene has received a Breakthrough Device designation from the FDA for its BlueLeaf endovenous valve system.

The catheter-based system is designed to correct deep vein reflux, one of the underlying causes of chronic venous insufficiency, by forming new, autologous vein valves out of the patient’s vein wall tissue using an ultrasound image-guided approach.

The company is sponsoring clinical research on the system in three study programs worldwide, including an early feasibility study in the U.S.