Cook Medical’s Zilver Vena Stent Approved and Launched in Europe
September 23, 2011—Cook Medical (Bloomington, IN) has received CE Mark approval for the Zilver Vena venous self-expanding stent, which is designed and approved to treat symptomatic iliofemoral venous outflow obstruction. The company announced the launch of the product on September 10 at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Munich, Germany. In the United States, the Zilver Vena stent is an investigational device that is not approved for sale.
According to Cook Medical, the Zilver Vena is based on the company’s existing Zilver technology and is designed to address many of the challenges of stenting diseased veins. The Zilver Vena is a flexible, self-expanding stent made with shape memory nitinol. The device is available in 14- and 16-mm diameters and 60-, 100-, and 140-mm lengths. The Vena is compatible with 7-F sheaths and 9-F guiding catheters. It is deployed via 80- and 120-cm delivery systems.
“There is a significant lack of awareness of modern interventional techniques to remove thrombus and restore venous patency,” commented Gerard O’Sullivan, MD. “Until now, physicians who recognize the benefits of venous stenting have been forced to adopt off-label use of stents designed for the arteries. This is challenging because compared with arteries, veins have less muscle in the wall to keep them open and also have much higher elastic recoil, which tends to close them down unless you use a stent with high radial force.”