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Efficacy of OrbusNeich's Genous Bio-Engineered R Stent Compares,Favorably to Drug-Eluting Stents

istry is target vessel failure at 12 months

The e-HEALING registry is part of the company's broad HEALING (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth) program, which is a series of studies to evaluate the safety and efficacy of the Genous Bio- engineered R stent. In other HEALING program updates provided at EuroPCR:

    -- Harry Suryapranata, M.D., principal investigator of HEALING AMI,

       announced the completion of patient enrollment in the trial, which is a

       single-center, prospective, non-randomized study of 60 patients with ST

       segment elevation AMI with one infarct lesion in a single vessel. The

       primary endpoint is stent thrombosis at 30 days post-procedure. Patient

       follow-up is underway, and results will be announced in October at TCT

       2007 in Washington, D.C.


    -- OrbusNeich reported that 52 patients have received the Genous stent as

       part of HEALING IIB, a multi-center, non-randomized, prospective study

       with a primary endpoint of in-stent late loss at six months.

Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.

OrbusNeich designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. The company's product portfolio includes the Genous(TM) Bio-engineered R stent, an antibody-coated device that is the first-ever stent to capture a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process following placement. Other products are stents, balloons and guiding catheters marketed under the names of Blazer(TM), R
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