Zilver Vena, the only stent designed specifically to meet the challenges of iliofemoral venous stenting, will be launched commercially on a large-scale at CIRSE 2011 for use in Europe by Cook Medical. The stent, from Cook Medical, is available in 14 and 16mm diameters and 60, 100 and 140mm lengths.
The self-expanding nitinol stent received CE mark approval in October 2010 and has been tested on a small scale by researchers and selected physicians in Europe since then. “We have now received plenty of positive feedback and feel ready to push for a much larger commercial roll-out,” Rob Lyles, vice president and global leader of the Peripheral Intervention Business Unit, exclusively told Interventional News, ahead of the planned launch.
“A stent designed for use in the venous anatomy needs to be very different from a stent designed for use in the arterial system, which is a high-pressure system. Veins are quite elastic and tend to clamp down on themselves, so Zilver Vena provides a combination of high radial force (which is needed to the keep the vessel open) and flexibility (which is needed to work within tortuous anatomy),” he said.
Zilver Vena is approved for use in symptomatic venous outflow obstruction in the iliofemoral veins, a common complication of deep vein thrombosis and May-Thurner syndrome. “Patients with venous thromboembolism do not have many options. They are currently treated with compression stockings, by elevating the leg or with different pharmaceutical agents which can have side-effects. There is a general paucity of clinical evidence when it comes to endovascular treatments in the venous system, and we hope to initiate and continue studies to build the evidence base in this arena,” said Lyles.
Lyles made the point that the stent becoming widely available across Europe was a major development which would allow physicians not to have to use arterial stents off-label in the veins.
The stent, from Cook Medical, is available in 14 and 16mm diameters and 60, 100 and 140mm lengths. Lyles said the company was currently “working our way through the regulatory process for FDA clearance in the USA.”