First drug-eluting stent approved in Europe for most severe form of arterial disease in the leg

Sep 6 2006

Cordis Endovascular, a division of Cordis Corporation, announced today that the Cypher Select Sirolimus-eluting stent received CE (Communite European) 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 Cypher Select Sirolimus-eluting stent is the first drug- eluting stent to obtain CE approval for severe claudication and critical limb ischemia (CLI) that is associated with infrapopliteal lesions.

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.

Dr Dierk Scheinert, from the Heart Center in Leipzig, Germany said "Percutaneous Transluminal Angioplasty (PTA) with or without treatment with bare metal stents has been shown to be a feasible alternative to bypass for CLI. However, the restenosis and re-obstruction following these procedures continue to exceed 50% after 12 months and may result in insufficient clinical improvement. For that reason, the use of drug-eluting stents, with their proven efficacy in the treatment of coronary artery disease, could be a major advance in the treatment of patients with CLI".

"The Cypher Select Sirolimus-eluting stent has shown efficacy in treating these severe peripheral arterial obstructions. Now with the CE Mark approval, patients across Europe have a new option to help open these critical arterial blockages that may have otherwise resulted in bypass surgery or amputation," said Dr. Dennis Donohoe, Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation.