Interim Analysis of 12-Month Data from e-HEALING Registry Shows Good Safety and Efficacy in Real-World Use of OrbusNeich's Genous Bio-engineered R stent
Additional Data Presentation Shows Encouraging 12-Month Outcomes from Single- Center Study Involving Patients with Predominantly Complex Lesions
WASHINGTON, October 14, 2008 /PRNewswire/ -- OrbusNeich today announced that an interim analysis of 12-month follow-up data from the global e-HEALING registry show good safety and efficacy in the real-world use of the company's Genous Bio-engineered R stent.
Presented by Professor Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2008, in Washington, D.C., the data from 3,200 patients were a target lesion revascularization (TLR) rate of 5%, a subacute thrombosis (SAT) rate of 0.4%, a late stent thrombosis (LST) rate of 0.3%, and a major adverse cardiac events (MACE) rate of 8.5%.
"The data further support the use of Genous as an alternative to drug- eluting stents, especially in light of the relatively minimal dual- antiplatelet therapy requirements with the stent," said de Winter, a co- principal investigator of the study. "Patient compliance with extended dual- antiplatelet therapy due to cost and other factors such as patients facing imminent non-cardiac surgery are issues that we can address by using Genous."
OrbusNeich's e-HEALING clinical study is a multi-center, worldwide (outside the United States) prospective registry with 5,000 enrolled 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.
In a related presentation at TCT 2008, de Winter and his colleagues reported data from the Academic Medical Center's single-center, real-world study of the Genous stent in patients with predominantly complex lesions. The data, presented in an electronic poster, show a good one-year clinical outcome regarding major adverse cardiac events, including a low incidence of stent thrombosis.
In the study, 236 patients were treated with Genous and completed 12-month follow-up. For the lesions treated, 64% were type B2 or C, 16% were chronic total occlusion, and 23% were bifurcated. The TLR rate was 8.1%, and the MACE rate was 13.6%. There was one patient with acute stent thrombosis at 24 hours, two patients with SAT at seven and 18 days, and no LST observed.
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 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), Scoreflex(TM), Sapphire(TM), Sapphire(TM) NC, 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; Tokyo; and Shenzhen, China. OrbusNeich, which has provided cardiology devices to physicians through its predecessor companies since 1979, today supplies products to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.
The data presentations listed in this news release are available on OrbusNeich's Web site, which is located at www.orbusneich.com.
OrbusNeich is displaying the Genous Bio-engineered R stent and other products at booth No. 1011 at TCT 2008.
Product images are available on request.
Web site: http://www.OrbusNeich.com//
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Posted: October 2008