5,000 Patients Enrolled in EPC Stent Registry
November 14, 2007 – More than 120 sites in 29 countries and more than 5,000 patients are now enrolled in OrbusNeich’s e-HEALING clinical study, a monitored multi-center, worldwide – not including the United States - prospective registry of patients treated with the Genous Bio-engineered R stent.
Unlike drug-eluting stents, Genous is coated with an antibody that 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.
The study protocol recommends that patients receive one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary endpoint of the registry is target vessel failure at 12 months.
Robbert de Winter, M.D., Ph.D., F.E.S.C., a co-principal investigator of the study and director of the catheterization laboratory at the Academic Medical Center in Amsterdam, added: "We look forward to our continued reporting of the patient follow-up data. Our next presentation is expected to be at the American College of cardiology's annual scientific session early next year."
For more information: www.orbusneich.com