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XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System
Date:10/22/2007

ificity about their questions and the potential impact, if any, on our timeline, we will provide an update."

The company is also reiterating guidance that it expects to commercialize Custom NX in Europe in the second half of 2008.

About the CUSTOM Trials

The CUSTOM I trial is a 30-patient first-in-man study designed to evaluate the preliminary safety and feasibility of in-situ stent customization. CUSTOM I's positive eight-month clinical results have been sustained at two years with no new MACE events, zero restenosis and no late stent thrombosis.

The CUSTOM II trial is a 100-patient study designed to evaluate the safety and efficacy of Custom NX for the treatment of long and multiple lesions. Of the 100 patients enrolled, 69 patients were enrolled in the long-lesion arm, and 31 patients were enrolled in the two-lesion arm of the study. CUSTOM II enrolled one of the most difficult to treat patient populations ever studied in a DES trial. In the CUSTOM II patient population, the average vessel diameter was 2.57mm and the average lesion length was 28.7mm. Twenty-six percent of the study participants were diabetic. The percentage of patients with ACC/AHA lesion grade B2 or C was 65.1 percent. CUSTOM II's six-month clinical results have been sustained at one year. The target lesion revascularization rate remained constant at four percent, with no new MACE events, and no late stent thrombosis.

The company's CUSTOM III clinical trial completed enrollment in July as previously announced, and the company expects the first available data to be presented at the 2008 Euro-PCR meeting.

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 de
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SOURCE XTENT, Inc.
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