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XTENT Receives CE Mark Approval for CUSTOM NX (R) Drug-Eluting Stent System
Date:3/19/2009

60 millimeter Custom NX 60 is the world's longest coronary stent to ever be approved

MENLO PARK, Calif., March 19 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced that it has received CE Mark approval for its CUSTOM NX drug-eluting stent (DES) System. The CE Mark indicates that the CUSTOM NX DES System may be marketed in the European Union as well as other countries that recognize the CE Mark and that the product complies with applicable safety and quality standards. The approval includes both the Custom NX 36, a 36 millimeter stent and the Custom NX 60, a 60 millimeter stent.

"Receipt of the CE Mark is an important accomplishment and a validation of the strength of our clinical data," stated Gregory D. Casciaro, President and Chief Executive Officer of XTENT. "It is a tribute to the hard work and dedication of our people as well as the collaborative effort of our drug coating provider, Biosensors. We look forward to the opportunity to bring this revolutionary new technology to patients and physicians throughout the European Union."

The CE Mark approval of the Custom NX DES System represents a number of important firsts in the treatment of coronary artery disease including:

  • Approval of the first ever customizable stent system
  • Approval of the Custom NX 60, the longest coronary stent system ever to be approved for sale
  • Approval of the first stent system to allow treatment of multiple lesions using one catheter
  • Approval of the first stent system to incorporate a post dilation feature on the delivery catheter

About the Custom NX(R) Drug Eluting Stent System

The Custom NX DES System is designed to enable a more personalized approach to the treatment of arteria
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SOURCE XTENT, Inc.
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