December 27, 2007 - XTENT Inc. announced that it has submitted its application to the designated European Notified Body for CE Mark approval of its Custom NX DES System, while it continues U.S. pivotal trial discussions with the FDA.
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.
