Abbott gets FDA approval for drug-coated stent

Drug developer and medical device maker Abbott Laboratories said Wednesday it received Food and Drug Administration approval for its anticipated drug-coated stent, Xience V.

The approval adds another drug-coated stent to what developers hope is a recovering market following several years of bad publicity. Abbott and its rivals have seen sales of drug-coated stents decline over the past few years after research questioned their safety and effectiveness compared with older, bare-metal versions.

The devices are used to open and unclog blocked arteries, and drug coatings are used to prevent the growth of scar tissue.

Companies have been touting more recent studies that show the stents are both safe and effective.

Abbott said it would launch the stent immediately. It enters the market against Natick, Mass.-based Boston Scientific Corp.'s Taxus, which did not perform well during the first quarter. Drug-coated stent sales fell 9 percent to $428 million for Boston Scientific during the period.

Xience V's approval also means approval for Boston Scientific's Promus stent. Boston Scientific and Abbott have a deal for shared rights on the technology behind Xience, with Boston Scientific's version called Promus, though it pays a share of Promus revenue to Abbott. The deal dates back to Boston Scientific's 2006 buyout of Guidant Corp.

Promus is actually made by Abbott but distributed by Boston Scientific.

Meanwhile, rival Medtronic Inc., based in Minneapolis, has been pushing its Endeavor drug-coated stent, which hit the market during the fourth quarter. New Brunswick, N.J.-based Johnson & Johnson has been trying to gain market share with its Cypher stent.

Shares of Abbott rose 58 cents to $54.82 in after-hours trading after rising 3 cents to close at $54.24 during the regular trading session.