Cordis Drug Coated Stent Will Be Approved
October 24, 2002  Cordis (a subsidiary of Johnson & Johnson, NYSE: JNJ) received a unanimous (8-0) recommendation for FDA approval of its Cypher sirolimus-eluting stent system from the Circulatory System Device Panel. The panel recommended that regulators have Cordis perform an additional pharmacokinetic study, and provide materials for patient education and product labeling. The label will most likely cover the indication of reduction of restenosis of de novo coronary artery lesions in patients with coronary artery disease. As far as post-marketing surveillance requirements, the panel accepted Cordis’ recommendation for a five-year follow-up of patients enrolled in the three principal clinical trials conducted to date.  The panel recommendation makes Cypher FDA approval a virtual certainty. Cypher will likely be approved in early 2003. Cypher received European CE Mark approval in April 2002 and is now available in approximately 50 countries worldwide. Cypher’s first mover advantage in the competitive drug-coated stent market gives it the inside track, as these innovative biomedical products should boost the stent market to close to $4 billion in a few years. Other coated stent systems approaching the market are from Guidant (NYSE: GDT) and Cook as well as from Boston Scientific (NYSE: BSX).
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