Johnson & Johnson subsidiary Cordis Corporation says its third-generation drug-eluting stent, Cypher Select, has been stamped with a Communite European seal.
Cypher Select features a better stent delivery system, designed to facilitate delivery of the drug to the site of a lesion, combined with the “excellent, long-term clinical performance” for which its predecessor is widely known, the group said in a statement.
With CE mark now secured, Cordis says it is aggressively ramping-up manufacturing capacity in preparation for the product’s launch, which is scheduled to being in September with a view of a full market introduction by the end of the year.
News of Cypher Select’s approval in Europe will not be sitting well with rival stent maker Boston Scientific, which has been desperate to slow the encroachment of Cypher into its Taxus 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.