Enrollment Completed for DIVERGE Trial of Drug-Eluting Stent System for Bifurcation Lesions
December 13, 2007 - Devax Inc. announced that it has completed patient enrollment in the DIVERGE clinical trial evaluating its novel AXXESS Bifurcation Stent System.
The prospective, multi-center trial that enrolled 302 patients, is the largest study conducted to date with a drug-eluting stent specifically designed for treating bifurcation lesions. Bifurcation lesions are areas of atherosclerotic disease occurring at a location where one large vessel divides into two smaller vessels.
"The DIVERGE trial and the AXXESS System are important because of the frequent presentation of bifurcation lesions in our daily clinical practice," said Stefan Verheye, M.D., Ph.D., co-principal investigator of the study and co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium. "Conventional drug-eluting stents are technically challenging to place in bifurcation lesions since they are not designed for the unique anatomical characteristics of coronary bifurcations. As a result, these types of lesions are associated with high complication and restenosis rates compared to conventional lesions. We will submit the data for the next appropriate medical meeting."
The Devax AXXESS Biolimus A9 Eluting Bifurcation Stent System is a proprietary self-expanding Nitinol stent specifically engineered for the treatment of coronary and vascular bifurcation lesions. The stent is coated with Biolimus A9(R), a drug uniquely formulated to prevent restenosis in a coronary artery and a next-generation bioabsorbable polymer, Polylactic acid (PLA), which is designed to release the drug over time. The conical shape of the stent is specifically designed to conform to the anatomy of the bifurcation and to provide interventional cardiologists with the ability to treat the bifurcation without compromising access to the side branch.
To date, more than 500 patients worldwide have been treated using the AXXESS Bifurcation Stent System. More than 400 patients have received the drug-eluting version of the stent.
For more information: www. devax.net