Boston Scientific’s second-generation drug-eluting stent, Taxus Liberte, has been cleared in Europe to treat a broader range of patients with blockages in their coronary arteries.
The approval extends the approved uses of Taxus Liberte (paclitaxel) from newly-diagnosed lesions to restenotic lesions (in-stent restenosis, in which an existing stent has become blocked) and total occlusions in patients with coronary artery disease, including acute myocardial infarction (AMI).
These new indications account for more than 20% of all coronary interventions, said Boston Scientific, adding that Taxus Liberte stent system is now the only drug-eluting stent approved in Europe for this range of uses.
The approval comes at a time when Boston Scientific has been desperate to slow the encroachment of rival drug-eluting stent Cypher (sirolimus) from Johnson & Johnson into its market share. Between them, the two products dominate the $5.5 billion coated stent market, with roughly a half-share apiece, although both are facing competition for the first time from other coated stents, including Xience V from Abbott (formerly Guidant), which is due to reach the European market in the third quarter of this year.
Meanwhile, Medtronic has launched its own drug-eluting stent, Endeavour (zotarolimus), in Europe and other parts of the world and is scheduled to introduce it in the USA next year. And Canadian firm Conor MedSystems earlier this year won European approval to sell its own paclitaxel-eluting stent, CoStar, in competition to Taxus. Conor is suing Boston Scientific to try to invalidate the patent protection on Taxus’ paclitaxel coating.
In addition to the new indications, Boston Scientific also won European approval for a bigger, 4mm diameter Taxus Liberte stent intended for drug delivery to larger blood vessels.