Healthcare Industry News: transcatheter
News Release - October 13, 2008
Custom NX(R) Drug Eluting Stent System Continues to Demonstrate Favorable Outcomes in Challenging Patient Populations at One, Two and Three YearsZero Incidence of Late Stent Thrombosis Reported in CUSTOM I, II, and III Trials
WASHINGTON and MENLO PARK, Calif., Oct. 13 (Healthcare Sales & Marketing Network) -- XTENT, Inc. (Nasdaq: XTNT ) today announced positive long-term follow-up data from the CUSTOM I, II and III clinical trials that reinforces the efficacy of the Custom NX® drug eluting stent (DES) system in treating patients with coronary artery disease. The CUSTOM clinical trials are prospective studies designed to investigate the safety and efficacy of the Custom NX DES system. The three trials have enrolled 220 patients and represent one of the most challenging patient populations -- those with long and/or multiple lesions -- ever studied in DES trials.
"We are pleased to see favorable outcome trend data continue with the CUSTOM Trials even as we look out as far as two and three years of follow-up in very complex patients," commented Pieter R. Stella, MD, Director, Cardiovascular Research, University Medical Centre Utrecht, The Netherlands, and one of the CUSTOM clinical trial investigators, who presented the data during a DES panel at the Cardiovascular Research Foundation's (CRF) twentieth annual transcatheter Cardiovascular Therapeutics (TCT) meeting. "To date, the incidence of late stent thrombosis in all three CUSTOM trials is zero percent and this is particularly encouraging."
The results presented today include three-year follow-up data from 30 patients studied in CUSTOM I, two-year data from the 100 patients in CUSTOM II and one-year data in 90 patients enrolled in CUSTOM III. Patients enrolled in these trials presented with the smallest reference vessel diameter (RVD) ever in a DES study, and CUSTOM II featured the longest average lesion length ever in a DES study.
"These long-term safety data continue to support XTENT's development of Custom NX as the true next-generation drug eluting stent, particularly because the ability to customize care to the individual allows us to treat patients with long lesions and multi-vessel disease who are not well-served by currently available technology," said Gregory D. Casciaro, XTENT's President and CEO.
To view the data presentation, go to: http://www.xtentinc.com.
About Custom NX
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 delivery system allows physicians to customize the length and diameter of the stent at the site of the lesion by enabling separation at each six-mm segment and allowing for the placement of up to 60 mm of stent. The stent is coated with Biolimus A9 and PLA, a biodegradable drug carrier.
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® 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 regulatory approval or commercialization of its products, regulatory approval of XTENT's products for treatment of long lesions, the timing of the release of its clinical trial data. 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 June 30, 2008. This quarterly report was filed with the SEC on August 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.
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