Next-gen Boston Scientific stents approved

Boston Scientific Corp. said today it won US regulatory approval for its next generation drug-eluting stents.

Natick-based Boston Scientific, whose shares were bid higher in premarket trading, said it plans to immediately launch its Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System, the only drug-eluting stent on the U.S. market for use in vessels as small as 2.25 mm in diameter.

The Food and Drug Administration also approved its Taxus Express2 Paclitaxel-Eluting Coronary Stent System for the treatment of in-stent restenosis, or reclogging of the vessels, in bare-metal stents, the company said.

Stents are tiny wire-mesh tubes that are inserted into diseased arteries to prop them open after they have been surgically cleared of blockages.

Stent sales have fallen in recent years amid concerns that the devices could lead to late stent thrombosis, a small but deadly risk of blood clots forming inside the stent a year or more after implantation.

Boston Scientific sales led the decline as more competitive products entered the market.

Shares were bid at $13.06 and offered at $13.10 in premarket trading, up from their New York Stock Exchange close on Wednesday of $12.61.