Johnson and Johnson stent ‘represents European first’

Johnson & Johnson has claimed that its new Cypher Select stent is the first drug-eluting stent to be approved in Europe to treat infrapopliteal critical limb ischemia (CLI) – the most severe form of arterial disease of the leg.

The Cypher Select stent elutes sirolimus and is the first to have received a CE mark for the treatment of CLI associated with infrapopliteal lesions.

CLI is described by the company as a “severe obstruction” of the leg arteries, resulting in severe pain below the knee and the development of wounds, which can necessitate amputation.

Patients in the UK and all other EU countries will now be able to receive the Cypher Stent to treat the debilitating disease.

Dr Dennis Donohoe, vice president of worldwide clinical and regulatory affairs for Cordis, the Johnson & Johnson company that developed the Cypher Stent, remarked: “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,” he added.

The global drug-eluting stent market is now estimated to be worth approximately $5 billion per year. Other major players include Boston Scientific and Abbott Vascular.

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