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XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention
Date:8/26/2008

r adverse cardiac events (MACE) were reported since the one-year analysis, and the incidence of late stent thrombosis for patients treated with Custom NX was zero percent. The CUSTOM I article published in EuroIntervention was recognized by the journal's editorial board as one of the six best papers submitted to the journal during the previous winter, and Lutz Buellesfeld, M.D., of the HELIOS Heart Center in Siegburg, Germany, received an award in conjunction with the publication after presenting it at the annual EuroPCR meeting in May.

The CUSTOM II trial was 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 EuroIntervention paper, titled "One year results of a new in-situ length-adjustable stent platform with a biodegradable Biolimus A9 eluting polymer: result of the CUSTOM-II trial," can be accessed at: http://www.europcronline.com/eurointervention/15th_issue/37/.

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 c
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SOURCE XTENT, Inc.
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