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news.Xtent has submitted application to the designated European notified body for CE Mark approval of its Custom NX DES System.
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Xtent’s CE Mark application includes the Xtent design dossier and the drug formulation submission from Biosensors International Group. Xtent plans to begin European sales of the Custom NX system in the second half of 2008 through partnerships with leading regional distributors, following CE Mark approval.
Gregory Casciaro, president and CEO of Xtent, said: “Completing our CE Mark filing is a major milestone toward achieving our goal of commercializing the Custom NX system in select European countries.”