IRVINE, Calif.--(BUSINESS WIRE)--Jan. 15, 2004--Devax Inc. today announced CE Mark approval for an expanded size range of the AXXESS(TM) bifurcated stent system for the treatment of stenosis at coronary bifurcations. With the CE Mark approval on the complete product line Devax intends to begin marketing the AXXESS stent in Europe in the first quarter of 2004.
The Devax AXXESS technology is a patented, multi-component stent delivery system comprising self-expanding Nitinol stents specifically engineered for the treatment of coronary and vascular bifurcation lesions. The easy-to-use stent system includes a conical stent that conforms to the bifurcation anatomy and provides full access to both side branches for additional interventional procedures.
In the United States in 2003 there were approximately 1 million percutaneous coronary interventions using about 1.5 million stents. Of these 1 million procedures, it is estimated that 17 percent or more involve lesions at a bifurcation. Standard stents currently used in this large patient group are not designed or approved for use in bifurcations and result in restenosis rates reported to be as high as 60 percent.
Commenting on the approval Jeff Thiel, President and CEO of Devax said: "In our clinical studies we have confirmed that the AXXESS stent provides an excellent tool for the Interventional Cardiologist to treat this difficult patient population. With the full product line available we will be able to treat a large share of the patients with this condition."
Devax is a private emerging medical device company engaged in the development of a proprietary bifurcated stent system that provides a clinical solution to treat coronary, carotid and peripheral vascular bifurcation lesions.
Devax Inc., Irvine Jeff Thiel, 949-461-0450
Source: Devax Inc.