Interventional device firm ev3 of Plymouth, MN, has received Food and Drug Administration 510(k) marketing clearance for its Protégé GPS nitinol self-expanding long stent.
The product is used to treat malignant biliary strictures, and will be available in the U.S. this month, according to the privately held company. The stent is also expected to receive CE Mark approval for use in Europe to treat biliary strictures and peripheral vascular disease, including the iliac artery, ev3 said.
By AuntMinnie.com staff writers
October 21, 2004
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