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Presented today by Robbert de Winter, M.D., Ph.D., at the European Societyof Cardiology (ESC) Congress 2007 in Vienna, Austria, the data fromOrbusNeich's e-HEALING registry show:
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"This real-world data strengthen our belief that Genous is a verypromising alternative to drug-eluting stents," said de Winter, a co-principalinvestigator of the study and director of the catheterization laboratory atthe Academic Medical Center in Amsterdam. "Genous appears to have the sameefficacy as drug-eluting stents but a better safety profile with only minimaldual-antiplatelet therapy requirements. This is an important finding in thatphysicians are becoming reluctant to burden their patients with the cost andcompliance issues associated with drug-eluting stents and their extensivedual-antiplatelet therapy requirements."
OrbusNeich's e-HEALING is a multi-center, worldwide (outside the UnitedStates) prospective registry of patients treated with the Genous Bio-engineered R stent in accordance with the instructions for use. The protocolrecommends that patients receive two weeks of statin treatment prior to theprocedure and one month of clopidogrel treatment after the procedure.Clinical follow-up takes place at 30 days, six months and 12 months. Theprimary outcome of the registry is target vessel failure at 12 months.
Unlike drug-eluting stents, Genous, which is coated with an antibody,captures a patient's endothelial progenitor cells (EPCs) to accelerate thenatural healing process. EPCs circulate in the bloodstream and are involvedin the repair of blood vessels. When attracted to the surface of Genous, EPCsrapidly form an endothelial layer over the stent that provides protectionagainst thrombus and minimizes restenosis.
OrbusNeich designs, develops, manufactures and markets innovative medicaldevices for the treatment of vascular diseases. The company's productportfolio includes the Genous(TM) Bio-engineered R stent(TM), an antibody-coated device that is the first-ever stent to capture a patient's endothelialprogenitor cells (EPCs) to accelerate the natural healing process followingplacement. Other products are stents, balloons and guiding catheters marketedunder the names of Blazer(TM), R stent(TM), Sapphire(TM), Avita(TM), AvitaHP(TM), SafeCut(TM), Lumina(TM) and Saffron.
A global company, OrbusNeich is headquartered in Hong Kong and hasoperations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Shenzhen,China. OrbusNeich, which has provided cardiology devices to physiciansthrough its predecessor companies since 1979, today supplies products in morethan 60 countries. For more information, visit www.OrbusNeich.com.* For 296 diabetic patients at six months, the target lesion revascularization (TLR) rate was 2%, which is much lower than was anticipated * A TLR rate of 1.9% for 213 chronic total occlusion (CTO) patients at ] six months * For 923 patients with statin use, the major adverse cardiac events (MACE) rate at six months was 5.7%, while 116 patients without statin use experienced a MACE rate of 6.9% over the same period
SOURCE OrbusNeich
