FDA Approves Boston Scientific's Taxus Stent

Updated from March 4

The Food and Drug Administration on Thursday approved Boston Scientific's ( BSX) drug-coated stent for treating heart disease, which is expected to ignite a marketing battle with Johnson & Johnson ( JNJ).

Boston Scientific said Thursday that it would begin shipping the Taxus drug-coated stent to hospitals immediately, adding that it has "ample inventory in all sizes."

Taxus has been available in foreign markets, as has Johnson & Johnson's Cypher stent. Cypher has been available in the U.S. since last April, and many Wall Street analysts believe that Taxus will grab a majority market share because their research suggests that doctors find it easier to use.

In Friday premarket trading, Boston Scientific's stock was up $1.87, or 4.2%, to $45.99.

Stents act as wire-mesh scaffolding inside arteries to keep blood flowing, thus reducing the risk of heart disease or heart attack. These tubes are inserted into arteries following angioplasty, a procedure in which a catheter is inserted into an artery clogged with plaque. A balloon is then inflated to redistribute the plaque, opening the artery channel to allow a better blood flow. Stents are designed to reduce the chance of arteries reclogging.

Angioplasty changed heart care by reducing the need for more dramatic heart surgery. The first stents to reach the U.S. market just 10 years ago did a better job of reducing the reclogging -- or restenosis -- rate of the arteries than just the angioplasty procedure.

But these bare metal stents are being eclipsed by the drug-coated stents -- also called drug-eluting stents -- which allow medication to be released from the stent slowly into the artery to reduce reclogging. Separate tests by Boston Scientific and J&J show that the drug-coated stents have much lower reclogging rates then do bare metal stents.

These tests have not had head-to-head comparisons; Boston Scientific tests its drug-coated stent vs. a Boston Scientific bare metal stent, and J&J matched its drug-coated stent against a J&J bare metal stent.

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