|Cook Medical is launching a global study of its Zilver Vena stent.--Courtesy of Cook Medical|
Cook Medical is working to get its Zilver Vena stent FDA approved, launching a global trial to study the device's benefits for patients with iliofemoral venous outflow obstruction.
The self-expanding stent is designed to treat diseased veins near the hip, and Cook plans to enroll 243 patients at up to 30 sites in the U.S. and abroad, studying how well the device can correct vein stenosis in patients with obstructed vessels.
Chronic iliofemoral venous outflow obstruction can result in leg pain, throbbing, swelling and skin discoloration, Cook says, and Zilver Vena could make a world of difference for U.S. patients with few options.
Physicians often have to go off-label when treating venous obstructions, according to Cook, appropriating stents meant for arteries in procedures that are less than ideal. Zilver Vena is the first-ever stent designed specifically for iliofemoral veins, and the company says its technology provides the flexibility and radial force to treat veins' particular anatomy.
It's not clear when Cook hopes to get Zilver Vena on the market in the U.S.--the company didn't respond to a request for comment Thursday--but an expanded customer base for the stent would be another leap for Cook's vascular business. Last year, the company won FDA approval for Zilver PTX, the first drug-eluting stent indicated to treat peripheral artery disease in the U.S.
Zilver Vena got its CE mark in 2010 and has been on the market around the globe since then.
- read Cook's announcement