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Devax CE marks Axxess stent

This article was originally published in Clinica

Executive Summary

Devax's Axxess bifurcated drug-eluting stent is now available for sale in Europe, after the firm CE marked it. The self-expanding Nitinol stent, which elutes biolimus A9, is intended for bifurcated lesions. These occur in around 20% of patients treated with coronary angioplasty and stenting, the Lake Forest, California company estimates. Bifurcations are associated with an increased frequency of major adverse cardiac events compared with lesions in straight vessel segments, according to large trials such as SYNTAX and LEADERS. The 302-patient DIVERGE study, published in the Journal of the American College of Cardiology in March 2009, showed higher rates of clinical success and lower rates of restenosis with Axxess compared with other studies of bifurcated lesions.

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