Abbott receives CE Mark for Xience stent

Abbott has received CE Mark (Conformite Europeene) approval for a 2.25 mm version of its Xience V Everolimus Eluting Coronary Stent System.

The new smaller stent has been based upon the proven efficacy and positive safety results of the Xience V.

Charles Simonton, chief medical officer at Abbott Vascular, explained that lesions in smaller vessels tend to be more complex so it was important to have a drug eluting stent that could be “easily delivered” to the diseased area of the vessel.

“With Xience V 2.25 mm, physicians now have access to a smaller stent that combines these critical attributes with the positive safety outcomes we have seen with Xience V,” he added.

Abbott has confirmed that the 2.25 mm version will be launched immediately in the majority of European markets and in certain countries in Asia and Latin America.

Abbott launched the stent in Europe and other international markets in 2006 and it is currently under review for approval by the US Food and Drug Administration.

Earlier this week, Abbott announced that its molecular diagnostics unit had entered into a partnership agreement with Genentech, Roche and OSI Pharmaceuticals to develop a gene test to assess the benefit of Tarceva (erlotnib).