Devax Receives IDE Approval To Set off DIVERGE II
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Devax, Inc. announced that the U.S. Eatable and Narcotic Governance has conditionally approved an Investigational Device Exemption ("IDE") for its AXXESS™ Biolimus A9® Eluting Bifurcation Stent Process (AXXESS System), allowing the company to initiate a pivotal clinical proof (DIVERGE II) of the slogan in the United States.
The DIVERGE II study is a multicenter, blinded, controlled, randomized trial comparing the treatment of bifurcation lesions with the AXXESS stent to guideline techniques with conventional stents. The Principal Investigator is Jeffrey Moses, M.D., Professor of Medicine and Director of the Centre for Intravascular Therapy at Columbia University Medical Center in New York.
Bifurcation lesions arise in approximately 20% of patients that are treated for ischemic heart disease with coronary angioplasty and stenting. Recent large scale clinical studies, such as SYNTAX and LEADERS, bear shown that lesions located at vessel bifurcations development the closeness of large adverse cardiac events by as much as 40% compared to lesions in straight vessel segments. Currently, there is no stent with an FDA approved message for custom in bifurcation lesions.
Devax has implanted over 430 AXXESS stents in two clinical studies conducted outside the United States. The second of these studies, DIVERGE I, enrolled 302 patients at 16 clinical centres in Europe, Australia, and Late Zealand. The 9 month spring from up for these patients was presented remain October at the Transcatheter Therapeutics conference in Washington, D.C. The data, published in the Step 23, 2009 inquiry of the Journal of the American Institute of Cardiology, expo high rates of clinical fame and low rates of restenosis compared to other studies of bifurcations.
Discussing the importance of the study, Professor Moses said, "DIVERGE II will be a landmark scan because there are many novel aspects to the trial. The AXXESS stent is the first drug eluting stent dedicated solely to bifurcation lesions. We espy these types of lesions often in diurnal practice, and they are difficult to treat with conventional stents and techniques. Also, this interpret is the inceptive randomized announce to compare a lesion-specific drug eluting stent to a standard device in a conglomerate vessel anatomy."
"This is the inaugural IDE approval of a drug eluting stent specifically designed for exercise in coronary bifurcations," said Jeff Thiel, Head of the state and CEO. "We chalk up focused our attention on being the first to in the United States with a committed DES, and this is an important step toward that goal."
The Devax AXXESS System 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 agree to the bifurcation anatomy and bestow all-inclusive access to both branches for further interventional procedures.
Devax, Inc., a private emerging medical device company located in Irvine, California, is busy in the boost of solutions for the treatment of atherosclerotic disease in coronary arteries.
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