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FDA Approves Smaller Version of J & J Stent

By Pharmaceutical Processing | September 22, 2009

BRIDGEWATER, N.J. (AP) — Medical product conglomerate Johnson & Johnson said Monday the Food and Drug Administration approved a smaller version of its drug-coated stent, Cypher. Stents are used to prop open arteries after they have been surgically cleared of fatty plaque. They have become one of the top-selling medical devices since companies began adding drug coatings in 2003 to prevent scar tissue from growing over the mesh. The new 2.25 mm Cypher stent is designed for use in small blood vessels, which are often difficult to treat. Smaller vessels are more likely to become reclogged, requiring additional procedures, according to J&J. FDA approved the new stent based on data showing that patients implanted with Cypher were 82 percent less likely to have a reclogged vessel than patients using a traditional bare-metal stents. J&J’s drug-coated stent competes with similar products from Boston Scientific, Medtronic and Abbott Laboratories.

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