NATICK, Mass. (AP) -- Boston Scientific Corp. said Thursday the Food and Drug Administration approved the medical device maker's new Taxus drug-coated stent.
The approval comes as Boston Scientific and its stent competitors try to recover from a yearlong downturn in sales for the devices which are used to prop open clogged arteries. The drug-coatings are used to prevent the growth of scar tissue.
The Taxus Express2 stent is the only stent on the market approved for use in vessels as small as 2.25 millimeters, the company said.
In 2006, studies began to show that patients with the drug-coated stents were more likely to develop potentially fatal blood clots months and even years after they were implanted. Doctors have since become more cautious about using them instead of bare-metal stents and companies have in turn released studies trying to shore up the safety profile of drug-coated stents.
Boston Scientific said Taxus is so far the world's most frequently implanted stent, with 4.6 million used and the drug already has an extensive record clinical trial and long-term follow-up record. The company plans to launch the new stent immediately.
The stent is also approved to treat the recurrence of a narrowing artery in patients who have a bare-metal stent, the company said.
Taxus stents compete heavily with Johnson & Johnson's Cypher stent. Other competitors include Abbott Laboratories Inc.'s Xience V and Medtronic Inc.'s Endeavor drug-coated stents.
In premarket trading, Boston Scientific shares rose 45 cents, or 3.5 percent, to $13.06.
