Zero Incidence of Late Stent Thrombosis Reported in CUSTOM I, II, and III Trials

WASHINGTON and MENLO PARK, Calif., Oct. 13 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced positive long-term follow-up data from the CUSTOM I, II and III clinical trials that reinforces the efficacy of the Custom NX(R) drug eluting stent (DES) system in treating patients with coronary artery disease. The CUSTOM clinical trials are prospective studies designed to investigate the safety and efficacy of the Custom NX DES system. The three trials have enrolled 220 patients and represent one of the most challenging patient populations -- those with long and/or multiple lesions -- ever studied in DES trials.

'We are pleased to see favorable outcome trend data continue with the CUSTOM Trials even as we look out as far as two and three years of follow-up in very complex patients,' commented Pieter R. Stella, MD, Director, Cardiovascular Research, University Medical Centre Utrecht, The Netherlands, and one of the CUSTOM clinical trial investigators, who presented the data during a DES panel at the Cardiovascular Research Foundation's (CRF) twentieth annual Transcatheter Cardiovascular Therapeutics (TCT) meeting. 'To date, the incidence of late stent thrombosis in all three CUSTOM trials is zero percent and this is particularly encouraging.'

The results presented today include three-year follow-up data from 30 patients studied in CUSTOM I, two-year data from the 100 patients in CUSTOM II and one-year data in 90 patients enrolled in CUSTOM III. Patients enrolled in these trials presented with the smallest reference vessel diameter (RVD) ever in a DES study, and CUSTOM II featured the longest average lesion length ever in a DES study.

'These long-term safety data continue to support XTENT's development of Custom NX as the true next-generation drug eluting stent, particularly because the ability to customize care to the individual allows us to treat patients with long lesions and multi-vessel disease who are not well-served by currently available technology,' said Gregory D. Casciaro, XTENT's President and CEO.

To view the data presentation, go to: http://www.xtentinc.com.

About Custom NX

Custom NX is designed to enable a more personalized approach to the treatment of arterial disease based on each patient's individual lesion characteristics.