Printer Friendly

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.

((Comments on this story may be sent to

COPYRIGHT 2010 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2010 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 Pharma
Article Type:Clinical report
Date:Jul 29, 2010
Previous Article:Acino reports EUR2.7m net loss for H1 2010.
Next Article:LifeWatch Q2 net profit drops to USD1.9m.

Terms of use | Privacy policy | Copyright © 2019 Farlex, Inc. | Feedback | For webmasters