Healthcare Industry News: drug-eluting stent
News Release - December 12, 2007
Devax Announces Completion of Enrollment of DIVERGE Trial of Novel Drug- Eluting Stent System for Bifurcation LesionsFive hundred patients treated with company's AXXESS(TM) System to date
LAKE FOREST, Calif., Dec. 12 (HSMN NewsFeed) -- Devax, Inc., a medical device company focused on developing next generation products for interventional cardiology, today announced that the Company has completed patient enrollment in the DIVERGE clinical trial evaluating its novel AXXESS(TM) Bifurcation Stent System. The DIVERGE trial, a prospective, multi-center trial which 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. A number of scientific papers estimate these lesions may occur in more than 500,000 people per year, or approximately 20 percent of all patients undergoing a stenting procedure worldwide.
"The DIVERGE trial and the AXXESS(TM) 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."
To date, more than 500 patients worldwide have been treated using the AXXESS(TM) Bifurcation Stent System. More than 400 patients have received the drug-eluting version of the stent.
"The DIVERGE data will help guide our development and registration strategy to deliver to the market the first drug-eluting stent specifically designed for bifurcation lesions," said Paul Buckman, CEO of Devax. "We believe our customized approach will fulfill interventional cardiologists' desire to tailor care to the specific clinical needs of each patient."
About the Devax AXXESS(TM) Biolimus A9® Eluting Bifurcation Stent System
The Devax AXXESS(TM) 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®, 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.
About Devax, Inc.
Devax, Inc. is a private, emerging medical device company developing a proprietary bifurcated stent system that is intended to provide a clinical solution to treat atherosclerotic disease in coronary bifurcations and left main coronary arteries. Coronary artery disease continues to be the number one cause of death in the United States and Europe. The Company believes there is significant potential for its unique stent system to serve as a platform technology to address and provide tailored care for bifurcations wherever they occur including those found in carotid and peripheral vascular disease. Devax is headquartered in Lake Forest, California.
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