Enrollment Reaches Milestone as Interim Data Show Pro-Healing Stent
Performs Comparably to Drug-Eluting Stents
HONG KONG, Nov. 8 /PRNewswire/ -- OrbusNeich today reported that 5,000 patients treated with the company's Genous stent at more than 120 sites in 29 countries are now enrolled in the global e-HEALING registry.
OrbusNeich's e-HEALING clinical study is a monitored multi-center, worldwide (outside the United States) prospective registry of patients treated with the Genous Bio-engineered R stent. 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.
"We reached this significant enrollment milestone earlier than we expected," said Sigmund Silber, M.D., F.A.C.C., F.E.S.C., professor of medicine, a co-principal investigator of the study. "This reflects an increase in demand and use for Genous by physicians concerned with drug- eluting stents."
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."
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.
"Completing enrollment in this large registry is an important milestone in our clinical development," said Samuel Rasmussen, OrbusNeich's president and CEO.
OrbusNeich designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. In addition to Genous OrbusNeich's 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 http://www.OrbusNeich.com.
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