An advisory panel late Wednesday recommended the Food and Drug Administration approve
Endeavor, a drug-coated coronary stent used to prop open arteries.
The panel, which comprised outside experts, reviewed safety and efficacy data from recent trials. Concerns about late stent thrombosis, or blood clots caused by the devices, has hurt the drug-eluting stent market in the past few years. Recent data raised questions about the stent's safety and efficacy compared to currently marketed products, but analysts had expected a positive recommendation.
If approved, Endeavor will compete with
Johnson & Johnson's
Medtronic expects the FDA will make a decision by the end of the year. The agency isn't bound to but does usually follow panel recommendations.
Shares were rising 2.7% to $58.20 in recent after-hours trading.