Efficacy of OrbusNeich's Genous Bio-Engineered R Stent Compares Favorably to Drug-Eluting StentsRisk of Late Thrombosis is Minimized with Genous Stent
BARCELONA, Spain, May 23, 2007 /PRNewswire/ -- The efficacy of OrbusNeich's Genous(TM) Bio-engineered R stent compares favorably to that of drug-eluting stents, while the risk of late thrombosis is minimized with the Genous stent, according to an interim analysis of post-marketing data presented today by Robbert de Winter, M.D., Ph.D., at EuroPCR 2007 in Barcelona, Spain.
Collected from more than 120 sites in 29 countries, follow-up data for patients who received at least one Genous Bio-engineered R stent show:
-- For 2,175 patients at 30 days, the target lesion revascularization (TLR) rate was 0.05%, the major adverse cardiac events (MACE) rate was 1.61%, and the sub-acute thrombosis (SAT) rate was 0.37% -- For 1,039 patients at six months, the TLR rate was 2.89%, the MACE rate was 5.87%, and the thrombosis rate was 0.88%
"The real-world data speak to the promise of OrbusNeich's innovative pro- healing approach with Genous, especially when we compare the findings to those of the drug-eluting stent registries," said de Winter, a co-principal investigator of the study and director of the catheterization laboratory at the Academic Medical Center in Amsterdam. "The importance of this interim data is that Genous appears to be as effective as drug-eluting stents with only the need for minimal dual-antiplatelet therapy, which is safer for patients and less expensive."
OrbusNeich's e-HEALING is a multi-center, worldwide prospective registry of patients treated with the Genous Bio-engineered R stent in accordance with the instructions for use. The protocol recommends that patients receive two weeks of statin treatment prior to the procedure and one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary outcome of the registry 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 stent(TM), Sapphire(TM), Avita(TM), Avita HP(TM), SafeCut(TM), Lumina(TM) and Saffron.
A global company, OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Shenzhen, China. OrbusNeich, which has provided cardiology devices to physicians through its predecessor companies since 1979, today supplies products in more than 60 countries. For more information, visit www.OrbusNeich.com.
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Posted: May 2007