Data from Patient Subsets of e-HEALING, a Worldwide Registry,Support Use of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM)as Alternative to Drug- Eluting Stents
VIENNA, Austria, September 03, 2007 /PRNewswire/ -- OrbusNeich today announced that post-marketing data from patient subsets of a global registry support the use of the company's Genous(TM) Bio-engineered R stent(TM) as an alternative to drug-eluting stents.
Presented today by Robbert de Winter, M.D., Ph.D., at the European Society of Cardiology (ESC) Congress 2007 in Vienna, Austria, the data from OrbusNeich's e-HEALING registry show:
* 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
"This real-world data strengthen our belief that Genous is a very promising alternative to drug-eluting stents," said de Winter, a co-principal investigator of the study and director of the catheterization laboratory at the Academic Medical Center in Amsterdam. "Genous appears to have the same efficacy as drug-eluting stents but a better safety profile with only minimal dual-antiplatelet therapy requirements. This is an important finding in that physicians are becoming reluctant to burden their patients with the cost and compliance issues associated with drug-eluting stents and their extensive dual-antiplatelet therapy requirements."
OrbusNeich's e-HEALING is a multi-center, worldwide (outside the United States) 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.
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(TM), 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.
Posted: September 2007