Drug-Eluting Bifurcation Stent Cleared for Use in Europe


July 30, 2010

July 30, 2010 – A drug-eluting coronary bifurcation stent received CE mark this week for clinical use in Europe. The Axxess Biolimus A9-Eluting Coronary Bifurcation Stent System uses a bioabsorbable coating on a self-expanding stent made by Devax.

Bifurcation lesions occur in about 20 percent of patients that are treated for ischemic heart disease with coronary angioplasty and stenting. Recent large scale clinical studies, such as SYNTAX and LEADERS, have shown that lesions located at vessel bifurcations increase the frequency of major adverse cardiac events by as much as 40 percent compared to lesions in straight vessel segments.

Devax has implanted over 430 Axxess stents in two clinical studies conducted outside the United States. The second of these studies, DIVERGE, enrolled 302 patients at 16 clinical centers in Europe, Australia, and New Zealand. The data, published in the Journal of the American College of Cardiology, show high rates of clinical success and low rates of restenosis compared to other studies of bifurcations.

The stent uses a self-expanding nitinol stent specifically designed for the treatment of coronary and vascular bifurcation lesions. The conical shape of the stent is designed to conform to the bifurcation anatomy and provide full access to both branches for additional interventional procedures. Devax has licensed the drug biolimus A9 and bioabsorbable coating from Biosensors International Group.

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