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XTENT Announces Positive Six-Month CUSTOM III Trial Data Presented at EuroPCR Meeting
Date:5/13/2008

Company Will Host Webcast to Review Data Tuesday, May 13 at 1:00 p.m. EDT

(7:00 p.m. CEST)

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. T
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SOURCE XTENT, Inc.
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