Cordis gets European approval for stent to treat arterial disease in the leg

By Elaine Rigoli

Tampa, Fla., Sept. 6 - Cordis Endovascular, a division of Cordis Corp., announced that the Cypher Select sirolimus-eluting stent received the CE Mark in Europe for use in the treatment of severe claudication and critical limb ischemia (CLI) of infrapopliteal lesions, which is the most severe form of arterial disease in the leg.

The company said the stent is the first drug-eluting stent to obtain CE Mark approval for severe claudication and CLI that is associated with infrapopliteal lesions.

The Warren, N.J.-based endovascular research company said severe claudication and CLI are characterized by severe obstruction of the arteries, which significantly decreases blood flow to the areas of the leg below the knee. Severe pain and skin ulcers or sores, possibly requiring amputation, mark this condition.

European regulatory approval allows Cordis Endovascular to offer the Cypher Select sirolimus-eluting stent when treating infrapopliteal severe claudication and CLI patients in all countries within the European Union.

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