Healthcare Industry News:  nitinol stent 

Devices Interventional Cardiology

 News Release - June 20, 2006

Devax Initiates Enrollment in the DIVERGE Clinical Trial with the AXXESS(TM) Drug Eluting Bifurcation Stent System

IRVINE, Calif.--(HSMN NewsFeed)--June 20, 2006--Devax Inc. announced today the initiation of the DIVERGE clinical study for the company's AXXESS(TM) Biolimus A9(TM) Eluting Bifurcation Stent System. The first patient to receive the AXXESS stent in this study was treated by 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.

Commenting on the procedure, Dr. Verheye stated: "The procedure went very well. The patient had a complex bifurcation lesion located at the LAD with a large first diagonal branch. We were able to span the bifurcation with the AXXESS stent and cover the ostium of the side branch with the stent, resulting in a very nice acute outcome. This is not easy to do with current stents and techniques, and this leads to long-term failures in this type of lesion. That's why having a dedicated, drug-eluting true bifurcation stent is so exciting."

The DIVERGE study is planned to enroll up to 600 patients at up to 40 centers in the United States, Europe, Australia and New Zealand. Data from the study is expected to be used in support of Devax's Premarket Approval (PMA) application to the United States Food and Drug Administration (FDA).

Discussing the significance of the study, Principal Investigator Jeffrey Moses, M.D., professor of medicine and director of the Center for Intravascular Therapy (CIVT) at Columbia University Medical Center, said:: "DIVERGE will be the largest single study of bifurcation lesions conducted to date and the first large-scale study of a drug eluting stent dedicated solely to bifurcation lesions. We see these types of lesions frequently in daily practice. They are difficult to treat with conventional techniques and a good therapy has not been proven so far. The unique design of the AXXESS stent holds much promise for these types of lesions."

The Devax AXXESS System technology is a proprietary self-expanding nitinol stent specifically engineered 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. Devax has licensed the drug Biolimus A9(TM) and a bioabsorbable polymer coating from Occam International, an affiliate of Biosensors International.

Commenting on this study, Brett Trauthen, chief scientific officer and vice president of clinical research, said: "We have recruited an exceptional group of interventional cardiologists to participate in the DIVERGE trial. The AXXESS stent is an innovative device for a difficult indication. We expect the outcomes of DIVERGE to be similar to the very favorable results we observed in the AXXESS PLUS clinical study, which was presented at TCT 2005."

Devax Inc., a private emerging medical device company located in Irvine, is engaged in the development of a proprietary bifurcated stent system that provides a clinical solution to treat atherosclerotic disease in coronary bifurcations and left main coronary arteries.


Source: Devax

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