Cook Incorporated Stents Gain Significant Approvals

Early this month, Cook Incorporated (Indianapolis, IN) announced that it had received regulatory approval to sell a drug-coated stent in European markets. Cook’s V-Flex Plus Coronary Stent System, which is coated with the drug paclitaxel to reduce reclogging of opened arteries, is now available at various medical facilities in Europe. The approval gives Cordis Corporation’s (Miami, FL) Cypher its first competition since becoming the only drug-coated stent to gain European approval in April of this year.

Cook was also given FDA clearance under an investigational device exemption to begin investigational use of its Zilver Vascular Stent System in human patients. The clearance specifies that Cook can use the system to treat the symptomatic vascular disease of the iliac arteries on 20 patients at four medical institutions initially, with plans to expand the study in the future to 150 patients at up to 20 investigational sites. The Zilver Stent consists of a self-expanding nitinol design with multiple gold radiopaque markers at each end to increase visibility under fluoroscopy.