Devax gains CE Mark for AXXESS drug eluting bifurcation stent.
M2 PHARMA-July 29, 2010-Devax gains CE Mark for AXXESS drug eluting bifurcation stent(C)2010 M2 COMMUNICATIONS
29 July 2010 - US medical device company Devax Inc said today it has obtained CE Mark for its AXXESS Biolimus A9 Eluting Coronary Bifurcation Stent System (AXXESS System).
Bifurcation lesions occur in approximately 20% of patients that are treated for ischemic heart disease with coronary angioplasty and stenting, the company said and added that recent 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% compared to lesions in straight vessel segments.
Devax said it has implanted over 430 AXXESS stents in two clinical studies conducted outside the US. The second of these studies, DIVERGE, enrolled 302 patients at 16 clinical centres 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 company added.
The Devax AXXESS System technology is a proprietary 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 said it has licensed the drug Biolimus A9 and bioabsorbable coating from Biosensors International Group.
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