Venclose’s Maven Gets FDA’s 510(k) Clearance to Treat Incompetent Perforator Veins
San Jose, Calif.-based Venclose has received the FDA’s 510(k) clearance for Venclose Maven, a radiofrequency ablation catheter for treatment of veins that are no longer preventing backflow of blood.
The catheter delivers heat which causes the diseased vein to shrink. The minimally invasive procedure allows physicians to treat refluxing perforator veins that contribute to painful conditions, such as venous stasis leg ulcers.
Venclose, which is focused on developing innovative treatments for venous reflux disease, is also pursuing a CE mark for the product.