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www.fdanews.com/articles/67363-devax-completes-enrollment-in-axxess-plus-clinical-study

DEVAX COMPLETES ENROLLMENT IN AXXESS PLUS CLINICAL STUDY

January 10, 2005

Devax announced that enrollment has been completed in the AXXESS PLUS clinical study for the company's AXXESS Drug Eluting Bifurcation Stent System -- a multi-component stent delivery system comprising self-expanding Nitinol stents specifically engineered for the treatment of coronary and vascular bifurcation lesions.

The AXXESS PLUS Stent System is designed specifically for bifurcation lesions to elute an antirestenonic drug. The AXXESS PLUS Clinical Study is a multicenter trial to evaluate both the acute and long-term clinical utility of the AXXESS PLUS Stent System for the treatment of bifurcated lesions in native coronary arteries.

The trial included 138 patients from 13 international study centers between July and December 2004. Six-month angiographic follow-up is scheduled to be completed in June 2005. Data from this study will be used to support a filing to obtain CE Mark. In addition the study will serve as a Phase I study for the company's FDA investigational device exemption filing.