Devax (Lake Forest, California), a developer of interventional cardiology products, in early December reported completion of patient enrollment in the DIVERGE clinical trial evaluating the company's novel AXXESS Bifurcation Stent System.
Devax said that the DIVERGE trial, a prospective, multi-center trial which enrolled 302 patients, is the largest study conducted to date with a drug-eluting stent (DES) specifically designed for treating bifurcation lesions, areas of atherosclerotic disease occurring at a location where one large vessel branches into two smaller vessels — and considered difficult to treat with a single straight stent.
Devax cites "a number of scientific papers" estimated that lesions may occur in more than 500,000 people per year, or about 20% of all patients undergoing a stenting procedure worldwide.
Stefan Verheye, MD, PhD, co-principal investigator of the study and co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital (Antwerp, Belgium), said, "The DIVERGE trial and the AXXESS System are important because of the frequent presentation of bifurcation lesions in our daily clinical practice. 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."
He added that data from the trial will be submitted at "the next appropriate medical meeting."
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.
"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."
The Devax AXXESS Biolimus A9 Eluting Bifurcation Stent System is a self-expanding Nitinol stent is coated with Biolimus A9, the company calling the drug "formulated to prevent restenosis in a coronary artery," and a next-generation bioabsorbable polymer, Polylactic acid (PLA), designed to release the drug over time.
The conical shape of the stent is 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.
Devax says it believes there is significant potential for its 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."