Clinical Data Presented at JIM 2010 Provide Further Evidence that the Genous(TM) Bio-engineered R Stent(TM) Could Be a Treatment of Choice for Patients Not Suitable for Long Term Dual Antiplatelet Therapy
ROME, Feb. 15 /PRNewswire/ -- OrbusNeich announced that clinical data presented at the Joint Intervention Meeting (JIM) 2010 in Rome provide further evidence that the company's Genous stent could be a treatment of choice for patients not suitable for long term dual antiplatelet therapy. The investigator initiated, 50 patient, multicenter study evaluated the safety of patients receiving only 10 days dual antiplatelet therapy undergoing stenting with the Genous Bio-engineered R stent. The primary endpoint was the absence of stent thrombosis or any occlusion within three months.
Presented by Giuseppe M. Sangiorgi, M.D., of the EMO Centro Cuore Columbus and San Raffaele Hospital, Milan, Italy, three-month follow-up data from the Genous in Patients with Reduced Antiplatelet Therapy study show no stent thrombosis of the lesions treated with a Genous Bio-engineered R stent, one case of myocardial infarction, not related to Genous stent implantation, and no sudden cardiac death.
"In our institution we use Genous for patients not suitable for prolonged DAPT (dual antiplatelet therapy) or in whom we feel it may have problems with DAPT compliance," said Professor Sangiorgi. "For these patients and based on the extremely promising results we have had with Genous stent utilization, I believe that this stent can be the optimal compromise we can offer to our patients in terms of efficacy and safety as compared to bare metal or drug-eluting stents".
The study population included patients with de novo coronary artery lesions located in the secondary branch vessel. The primary endpoint evaluated the absence of any occlusion and stent thrombosis of the Genous Bio-engineered R stent within three months, including the angiographic evidence of stent occlusion, myocardial infarction in the area of the stented vessel and sudden cardiac death not attributed to other causes.
Al Novak, OrbusNeich's chairman and CEO, said, "Patients who cannot tolerate or take dual antiplatelet therapy, such as patients who have to undergo non-coronary surgery and have to discontinue dual antiplatelet therapy, represent a challenging patient subset. These data demonstrate that such patients can benefit from treatment with the Genous Bio-engineered R stent."
Genous is OrbusNeich's patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.
OrbusNeich's Genous Bio-engineered R stent has been commercially available in over 60 countries since 2005. The Genous stent has been proven as a safe, effective alternative to drug-eluting stents and is supported by data from more than 5,000 patients in company-sponsored clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.
OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Bio-engineered R stent, as well as stents, balloons and guiding catheters marketed under the names of Blazer™, R stent, Scoreflex™, SafeCut™, Sapphire™, Sapphire NC, Avita™, Avita HP and Lumina™. OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo, Japan; and Shenzhen, China. OrbusNeich, which has provided medical devices to physicians through its predecessor companies since 1979, supplies products today to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.