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.
“Completing our CE Mark filing is a major milestone toward achieving our goal of commercializing the Custom NX system in select European countries,” said Gregory D. Casciaro, president and CEO of XTENT. “This submission further demonstrates Biosensors’ commitment to the success of Biolimus A9 and the ongoing collaboration between the two companies.”
XTENT is also continuing its work with the FDA to fulfill the necessary requirements to gain approval to start the CUSTOM IV pivotal trial. The company filed an Investigational Device Exemption (IDE) in September. XTENT and Biosensors are in the process of responding to questions from the FDA. XTENT will provide an update as to the anticipated start of the CUSTOM IV trial once both companies have completed discussions with the FDA.
For more information: www.xtentinc.com