( ay with coronary artery disease said ...)XTENT Announces Promising Six-Month Custom II Trial Data Presented,at EuroPCR Meeting,Health

ay with coronary artery disease," said Professor Eberhard Grube, MD, chief of cardiology at the Helios Heart Center in Siegburg, Germany and principal investigator of the CUSTOM II trial, who presented the data at the annual EuroPCR meeting in Barcelona. "Despite the complexity of patients treated, the Custom NX system allowed for very favorable results."

Difficult-to-Treat Patient Population

In the CUSTOM II patient population, the average vessel diameter was 2.57mm and the average lesion length was 28.7mm. Of the 100 patients enrolled in the trial, 26% were diabetic. The percentage of patients with ACC/AHA lesion grade B2 or C was 65.1%. This trial includes a high percentage of patients with complex lesions and one of the longest average lesion lengths studied of any DES clinical trial.

"The six-month clinical results from CUSTOM II are very promising and further our efforts to offer treatment options that meet the needs of patients with coronary artery disease," said Gregory D. Casciaro, President and CEO of XTENT. "In addition to the safety and efficacy data demonstrated, CUSTOM II achieved two firsts in coronary stenting history -- the first time a single stent system has been used to treat multiple lesions in multiple coronary arteries and the successful delivery of the longest coronary stent of any kind."

About the CUSTOM Trials

CUSTOM I was a 30 patient first-in-man study designed to evaluate the preliminary safety and feasibility of in-situ customization. CUSTOM I demonstrated positive early clinical results, with two MACE events in XTENT CUSTOM NX treated patients, zero restenosis and zero thrombosis at 12 month follow-up. The CUSTOM III clinical trial is also designed to evaluate in-situ customization for long lesions and multiple lesions. Enrollment of 90 patients at up to 15 European centers is ongoing. XTENT expects to submit an IDE application to the FDA within a timeframe to allow initiation of our pivotal studies i
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