- Five hundred patients treated with company's AXXESS(TM) System to date -
LAKE FOREST, Calif., Dec. 12 /PRNewswire/ -- 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
|SOURCE Devax, Inc.|
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