MENLO PARK, Calif. (AP) -- Medical device company Xtent Inc. said Thursday it asked European regulators to approve its Custom NX drug-coated stents.

Stents are mesh-metal tubes used to prop open clogged arteries after they have been cleared of plaque. The drug coatings are used to prevent scar tissue from growing over the stent.

Xtent still expects to launch the stents in Europe during the second half of 2008. Meanwhile, it is discussing clinical trial requirements with the U.S. Food and Drug Administration

 

MENLO PARK, Calif., Dec. 27 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT - News), the developer of customizable drug-eluting stent (DES) systems, today announced that it has submitted its 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.

"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 U.S. Food and Drug Administration (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.

About the Custom NX DES System

Custom NX is designed to enable a more personalized approach to the treatment of arterial disease based on each patient's individual lesion characteristics. The Custom NX system allows physicians to customize the length and diameter of the stent at the site of the lesion. The system features a proprietary modular stent design that consists of multiple 6mm cobalt chromium segments coated with Biolimus A9® and PLA, a biodegradable drug carrier, both developed and supplied to XTENT by Biosensors International Group. The Custom NX delivery system enables separation at each 6mm segment and allows for the placement of up to 60mm of stent. XTENT® Custom NX® DES Systems have not been approved for sale by any regulatory authority.

About XTENT

XTENT, Inc. is a medical device company focused on developing and commercializing innovative customizable drug eluting stent (DES) systems for the treatment of coronary artery disease (CAD). CAD is the most common form of cardiovascular disease and the number one cause of death in the United States and Europe. XTENT® Custom NX® DES Systems are designed to enable the treatment of single lesions, long lesions and multiple lesions of varying lengths and diameters, in one or more arteries with a single device.