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XTENT Announces Promising Six-Month Custom II Trial Data Presented,at EuroPCR Meeting

Trial Included One of the Most Challenging Patient Populations Studied of Any Drug-Eluting Stent (DES) Clinical Trial

BARCELONA and MENLO PARK, Calif., May 22, 2007 /PRNewswire-FirstCall/ -- XTENT, Inc. announces positive six-month follow-up data from the CUSTOM II clinical trial, which assessed the safety and efficacy of the company's investigational Custom NX(R) drug-eluting stent (DES) system for the treatment of long and multiple lesions in patients with coronary artery disease.

The single-arm prospective study evaluated the use of CUSTOM NX in patients with long lesions, defined as greater than 20mm, and patients with two 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. Up to two customizable stent deployments of up to 60mm total length were evaluated in the study. The primary endpoint was Major Adverse Cardiac Events (MACE) at six months, with clinical follow-up at one, six and 12 months, then annually for five years. Angiographic and intravascular ultrasound (IVUS) follow-up was conducted at six months. The anticoagulation regimen was clopidogrel for a minimum of three months plus aspirin.

At six-month follow-up, the MACE rate was 9%. Early adverse events (in hospital) occurred in five patients, including four myocardial infarctions and one death. At six months, four additional patients (4%) underwent target lesion revascularization. Angiographic and IVUS results demonstrated in-stent late loss was 0.31mm; in-segment late loss was 0.22mm; binary restenosis rate was 7.5%; and the percentage of neointimal volume was 3.3%.

"These data are particularly encouraging considering CUSTOM II enrolled one of the most difficult-to-treat patient populations ever studied in a DES trial and also mirrored the complex disease profile physicians are most likely to see among patients presenting tod
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