XTENT Announces European Regulat... ( MENLO PARK Calif. June 12 /- XTEN...)

XTENT Announces European Regulatory Update

Date:6/12/2008

MENLO PARK, Calif., June 12 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced a progress update regarding its application to the designated European Notified Body for CE Mark approval of its Custom NX(R) DES System. XTENT's European Notified Body confirmed that recently presented six-month follow up results from the CUSTOM III study will be incorporated by the Drug Agency, which reviews the drug formulation submission of XTENT's CE Mark application, into its current review cycle. XTENT's CE Mark application, which included two components, the XTENT design dossier and the drug formulation submission, was filed in December 2007.

"Given the positive results of CUSTOM III, we are encouraged that the Drug Agency, which has already approved Biolimus A9(R) and PLA combinations on two other DES platforms, has accepted the additional data for review. This, we believe strengthens an already robust submission for our Custom NX System," said Gregory D. Casciaro, XTENT's President and CEO. The company anticipates a response from its European Notified Body regarding its CE Mark application this summer.

About the Custom NX(R) 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 6 mm cobalt chromium segments coated with Biolimus A9(R) and PLA, a biodegradable drug carrier. The Custom NX delivery system enables the stent length to be adjusted in 6mm increments and allows for the placement of up to 60mm of sten
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SOURCE XTENT, Inc.
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