Friday, January 19, 2007 1:15:55 AM
http://biz.yahoo.com/ap/070118/boston_scientific_taxus.html?.v=1
Boston Scientific Taxus Shelf Life Upped
Thursday January 18, 10:06 am ET
Boston Scientific Taxus Express 2 Heart Stent Gets FDA Approval for Longer Shelf Life
NATICK, Mass. (AP) -- Medical device maker Boston Scientific Corp. said Thursday the Food and Drug Administration once again extended the shelf life for its Taxus Express 2 drug-coated heart stent.
The FDA approved extending the shelf life of the Taxus Express 2 to 18 months from 12 months. Stents are tiny wire mesh tubes that act as scaffolding inside diseased blood vessels. Drug-coated stents prevent irritated tissue from growing back through the mesh.
The company said it will begin changing U.S. labels on the devices immediately to reflect the change. Outside the U.S., the shelf life of the stent is 18 months.
In May 2005, the FDA approved an expanded shelf life for the stent to 12 months from nine months. Before August 2004, the shelf life was six months.
Shares of Boston Scientific dipped 4 cents to $18.16 in morning trading on the New York Stock Exchange.
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