BARCELONA, Spain and MENLO PARK, Calif., May 13 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced positive six-month follow-up data from the CUSTOM III clinical trial, which assessed the safety and efficacy of the Custom NX(R) drug eluting stent (DES) system for the treatment of patients with coronary artery disease.
The CUSTOM III clinical trial was a 90-patient prospective study to assess the safety and efficacy of the Custom NX drug eluting stent system in patients with up to two de novo lesions treatable with up to 60 mm of customizable stent length. The primary endpoint was major adverse cardiac events (MACE) at 30 days, with secondary endpoints of MACE at six months, binary restenosis, late loss, and stent thrombosis.
CUSTOM III enrolled a challenging patient population, with 67 percent of the lesions classified as complex B2/C, an average lesion length of 19.8 mm, and an average reference vessel diameter (RVD) of 2.6 mm. The CUSTOM III trial included some of the longest lesion lengths and smallest RVDs compared to previous drug eluting stent trials. Lesion length and RVD are two important indicators of disease complexity.
For the primary endpoint, MACE at 30 days, the rate was 2.2 percent, consisting of two in-hospital non Q-wave myocardial infarctions (MIs). At six-month follow-up the MACE rate for CUSTOM III was 7.8 percent. There were zero deaths, zero Q-wave MIs, two non Q-wave MIs, or 2.2 percent, and five clinically driven target lesion revascularizations, or 5.6 percent. There was one case of early stent thrombosis in the trial and zero late stent thrombosis. The in-stent late loss for CUSTOM III at six-month follow-up was 0.17 mm, the in-stent binary restenosis rate was 4.4 percent, and the neointimal hyperplasia (NIH) volume was 3.8 percent.
“The CUSTOM III results are very promising and demonstrate the safety of in situ customization for treatment of simple and complex lesions. The IVUS and angiographic results confirm the efficacy of the Custom NX stent, and the Biolimus A9(R) and PLA formulation,” said Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and Principal Investigator for the CUSTOM III clinical trial.
“Given the complexity of the patient population from CUSTOM III, we are excited about the results, which are consistent with the outcomes observed from the CUSTOM I and CUSTOM II trials,” said Gregory D. Casciaro, XTENT’s President and CEO. “We continue to be pleased with the safety profile and efficacy data of Custom NX in today’s real-world patients.”
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 separation at each 6 mm segment and allows for the placement of up to 60 mm of stent. The Custom NX DES System has not been approved for sale by any regulatory authority.
CUSTOM III Webcast and Slide Presentation
As previously announced, XTENT will host a teleconference and slide presentation to review the CUSTOM III data today at 1:00 p.m. EDT (7:00 p.m. CEST). To participate in the conference call, please dial 877-591-4957 (from the U.S.) or 719-325-4895 (international). The webcast and slide presentation can be accessed via the investor relations section of the Company’s website at http://investor.xtentinc.com/events.cfm. Please dial in or access the website five to 10 minutes prior to the beginning of the call. If you do dial in, please also view the slides via the webcast. The webcast will be archived on the website for a minimum of three months, and can be accessed at the investor relations portion of the company’s website at http://investor.xtentinc.com.
About XTENT
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 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 annual report on Form 10-K for the year ended December 31, 2007. This annual report was filed with the SEC on March 17, 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.
SOURCE XTENT, Inc.
