Xtent Inc. Announces CUSTOM I Data Receives Recognition from EuroIntervention
Published: Jun 19, 2008
MENLO PARK, Calif., June 17 /PRNewswire-FirstCall/ -- XTENT, Inc. today announced that the CUSTOM I two-year data that was published in the current issue of EuroIntervention was recognized by the journal's editorial board as one of the six best papers submitted to the journal this past winter. Lutz Buellesfeld, M.D., of the HELIOS Heart Center in Siegburg, Germany, and one of the study's investigators, received an award in conjunction with the publication after presenting it at the annual EuroPCR meeting.
"I am very pleased to congratulate Dr. Buellesfeld and all of the authors of the CUSTOM I two-year data for the due recognition they received from their peers," said Gregory D. Casciaro, XTENT's President and CEO. "We believe this demonstrates increasing awareness by the clinical community of the significant unmet need that remains in the treatment of coronary artery disease, and the potential for Custom NX's in-situ customization approach to fill that need."
The paper and presentation at the EuroPCR meeting discussed the previously released positive long-term follow-up data from the single-arm, 30-patient, first-in-man study evaluating the safety and efficacy of its Custom NX drug eluting stent (DES) system in patients with coronary artery disease. The results were first presented at the annual meeting of the Transcatheter Cardiovascular Therapeutics in October 2007.
The paper was selected as one of the six best articles submitted to EuroIntervention between November 2007 and February 2008. The winning papers were selected based on originality, clinical and scientific importance, scientific methods and accuracy and statistical analysis. EuroIntervention is the official publication of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and is endorsed by The European Society of Cardiology (ESC).
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 stent at one or more locations. The Custom NX DES System has not been approved for sale by any regulatory authority.
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(R) Custom NX(R) 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 size of the market for its products or market adoption of its products, and the outcomes for treated patients. 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 March 31, 2008. This quarterly report was filed with the SEC on May 13, 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.
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