SAN FRANCISCO, Sept. 22 /PRNewswire/ -- OrbusNeich announced today that interim data from a prospective registry showed good safety in a broad population of patients that underwent primary percutaneous coronary intervention (PCI) and implantation of the company's Genous Bio-engineered R stent for ST-elevation myocardial infarction (STEMI).
In the study of 652 consecutive STEMI patients, the rate of major adverse cardiac events (MACE) was 6.7 percent and the rate of subacute thrombosis was 1.1 percent at 30 days follow up. The interim data are presented in a poster by Jan-Henk Dambrink, M.D., Ph.D., of the Isala Klinieken, Zwolle, Netherlands, at the Transcatheter Therapeutics Conference in San Francisco.
"STEMI often presents challenges to interventional cardiologists as the condition can result in delayed stent endothelialization and lead to thrombosis with drug eluting stents," said Dambrink. "The interim data further support the safety profile of the Genous Bio-engineered R stent in this patient population as we confirm the low subacute stent thrombosis rate seen in several large trials for the Genous Bio-engineered R stent."
Harry Suryapranata, M.D., Ph.D., director of Diagram Clinical Research, Department of Cardiology, Isala Klinieken, added: "The interim results reflect a similar finding in a study of the Genous stent in 321 STEMI patients conducted at National University Hospital in Singapore. In the Singapore study, the early stent thrombosis rate was 0.9% with no further thrombotic events out to 12 months follow up."
Eleven percent of the patients in the study of 652 consecutive STEMI patients were diabetic, 41 percent had an anterior infarction, six percent were in heart failure, and six percent received an intra-aortic balloon pump (IABP). Half of the 23 patients who died were initial survivors of out of hospital cardiac arrest.
Al Novak, OrbusNeich's president and chief executive officer, said, "We are especially pleased to see these STEMI patients perform well in the study, as these interim results further confirm the safety profile that we have observed in other studies of our Genous Bio-engineered R stent and adds further evidence against the questionable conclusions reported from the small GENIUS-STEMI trial conducted in the Czech Republic. We understand the challenges that interventional cardiologists often face when treating patients with acute coronary syndromes, including patients needing primary PCI for STEMI. We believe that the Genous Bio-engineered R stent will continue to prove to be a safe and effective way of treating AMI and diabetic patients, as well as those who cannot tolerate dual antiplatelet therapy."
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(TM), R stent, Scoreflex(TM), SafeCut(TM), Sapphire(TM), Sapphire NC, Avita(TM), Avita HP and Lumina(TM). 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.
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