Xtent applies for CE Mark for DES system
Xtent, a developer of customizable drug-eluting stent (DES) systems, has submitted its application to the designated European Notified Body for CE Mark approval of its custom NX DES system.
The Menlo Park, Calif.-based Xtent said its CE Mark application includes its 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.
Xtent said it is also continuing its work with the FDA to fulfill the requirements to gain approval to start the CUSTOM IV trial. The company filed an Investigational Device Exemption in September 2007.
The Menlo Park, Calif.-based Xtent said its CE Mark application includes its 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.
Xtent said it is also continuing its work with the FDA to fulfill the requirements to gain approval to start the CUSTOM IV trial. The company filed an Investigational Device Exemption in September 2007.