June 1, 2009 - Devax Inc. today said FDA has conditionally approved an investigational device exemption (IDE) for its AXXESS Biolimus A9-Eluting Bifurcation Stent System, allowing the company to initiate a pivotal clinical trial (DIVERGE II) of the device in the U.S.
The DIVERGE II study is a multicenter, blinded, controlled, randomized trial comparing the treatment of bifurcation lesions with the AXXESS stent to standard techniques with conventional stents. The Principal Investigator is Jeffrey Moses, M.D., professor of medicine and director of the Center for Intravascular Therapy at Columbia University Medical Center in New York.
Bifurcation lesions occur in about 20 percent of patients treated for ischemic heart disease with coronary angioplasty and stenting. Recent large-scale clinical studies, such as SYNTAX and LEADERS, show lesions located at vessel bifurcations increase the frequency of major adverse cardiac events (MACE) by as much as 40 percent compared to lesions in straight vessel segments. Currently, there is no stent with an FDA approved indication for use in bifurcation lesions.
Devax has implanted more than 430 AXXESS stents in two clinical studies conducted outside the U.S. The second of these studies, DIVERGE I, enrolled 302 patients at 16 clinical centers in Europe, Australia, and New Zealand. The nine-month follow up for these patients was presented last October at the Transcatheter Therapeutics (TCT) conference in Washington, D.C. The data, published in the March 23, 2009 issue of the Journal of the American College of Cardiology, show high rates of clinical success and low rates of restenosis compared to other studies of bifurcations.
“DIVERGE II will be a landmark study because there are many novel aspects to the trial,” Dr. Moses said. “The AXXESS stent is the first drug-eluting stent dedicated solely to bifurcation lesions. We see these types of lesions frequently in daily practice, and they are difficult to treat with conventional stents and techniques. Also, this study is the first randomized study to compare a lesion-specific drug eluting stent to a standard device in a complex vessel anatomy.”
The Devax AXXESS 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.
For more information: www.devax.net