MENLO PARK, Calif., March 19 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT - News) 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® Drug Eluting Stent System
The Custom NX DES System 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 delivery system allows physicians to customize the length and diameter of the stent at the site of the lesion. Two sizes of the system have been developed, the Custom NX 36, a 36 millimeter stent and the Custom NX 60, a 60 millimeter stent. The stent is coated with Biolimus A9TM and the biodegradable drug carrier, PLA. XTENT has completed four clinical trials with follow-up data up to four years.
The Custom NX DES System has not been approved for sale in the United States.
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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding XTENT's business that are not historical facts may be "forward-looking statements" that involve risks and uncertainties. Specifically, these statements include, but are not limited to those concerning: XTENT's expectations with respect to the timing of the commercialization of its products in the European Union or elsewhere. Forward-looking statements are based on management's current, preliminary expectations, and are subject to risks and uncertainties that could cause actual results to differ from the results predicted and which are included in the "Risk Factors" section of XTENT's quarterly report on Form 10-Q for the quarter ended September 30, 2008. This quarterly report was filed with the SEC on November 12, 2008, and is available on the company's investor relations website at http://www.xtentinc.com and on the SEC's website at http://www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. XTENT undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.