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"We are pleased to see favorable outcome trend data continue with theCUSTOM Trials even as we look out as far as two and three years of follow-upin 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 dataduring a DES panel at the Cardiovascular Research Foundation's (CRF) twentiethannual Transcatheter Cardiovascular Therapeutics (TCT) meeting. "To date, theincidence of late stent thrombosis in all three CUSTOM trials is zero percentand this is particularly encouraging."
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The results presented today include three-year follow-up data from 30patients studied in CUSTOM I, two-year data from the 100 patients in CUSTOM IIand one-year data in 90 patients enrolled in CUSTOM III. Patients enrolled inthese trials presented with the smallest reference vessel diameter (RVD) everin a DES study, and CUSTOM II featured the longest average lesion length everin a DES study.
"These long-term safety data continue to support XTENT's development ofCustom NX as the true next-generation drug eluting stent, particularly becausethe ability to customize care to the individual allows us to treat patientswith long lesions and multi-vessel disease who are not well-served bycurrently available technology," said Gregory D. Casciaro, XTENT's Presidentand 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 thetreatment of arterial disease based on each patient's individual lesioncharacteristics. The Custom NX delivery system allows physicians to customizethe length and diameter of the stent at the site of the lesion by enablingseparation at each six-mm segment and allowing for the placement of up to 60mm of stent. The stent is coated with Biolimus A9 and PLA, a biodegradabledrug carrier.
The Custom NX DES System has not been approved for sale by any regulatoryauthority.
About XTENT
XTENT, Inc. is a medical device company focused on developing andcommercializing innovative customizable drug eluting stent (DES) systems forthe treatment of coronary artery disease (CAD). CAD is the most common formof cardiovascular disease and the number one cause of death in the UnitedStates and Europe. XTENT(R) Custom NX(R) DES Systems are designed to enablethe treatment of single lesions, long lesions and multiple lesions of varyinglengths and diameters, in one or more arteries with a single device.
Forward Looking Statements
This press release contains forward-looking statements within the meaningof the U.S. Private Securities Litigation Reform Act of 1995. Statements inthis press release regarding XTENT's business that are not historical factsmay be "forward-looking statements" that involve risks and uncertainties.Specifically, these statements include, but are not limited to thoseconcerning: XTENT's expectations with respect to the timing of regulatoryapproval or commercialization of its products, regulatory approval of XTENT'sproducts for treatment of long lesions, the timing of the release of itsclinical trial data. Forward-looking statements are based on management'scurrent, preliminary expectations, and are subject to risks and uncertaintiesthat could cause actual results to differ from the results predicted and whichare included in the "Risk Factors" section of XTENT's quarterly report on Form10-Q for the quarter ended June 30, 2008. This quarterly report was filedwith the SEC on August 12, 2008, and is available on the company's investorrelations website at http://www.xtentinc.com and on the SEC's website athttp://www.sec.gov. Undue reliance should not be placed on forward-lookingstatements, which speak only as of the date they are made. XTENT undertakesno obligation to update publicly any forward-looking statements to reflect newinformation, events or circumstances after the date they were made, or toreflect the occurrence of unanticipated events.
SOURCE XTENT, Inc.