Devax has received CE (Conformite Europeenne) Mark for its Axxess Biolimus A9 Eluting Coronary Bifurcation Stent System (Axxess System) to commence sales in the EU and other countries that recognise the CE Mark.
Devax claimed that its 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 has licensed the drug Biolimus A9 and bioabsorbable coating from Biosensors International Group.
Devax said that it has implanted around 430 Axxess stents in two clinical studies conducted outside the US. The second of these studies, Diverge, enrolled 302 patients at 16 clinical centers in Europe, Australia, and New Zealand.
Jeff Thiel, president and CEO of Devax, said: “The treatment of coronary bifurcations represents a large market and is one of the most challenging procedures for interventional cardiologists.
“Our clinical data has shown the long term benefits of the AXXESS stent and so we are pleased to be able to provide this unique stent architecture and believe that it offers significant advantages over other devices.”