Navigation Links
OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM) is Safe in a Broad Population of Patients with Primary PCI for STEMI
Date:9/22/2009

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."

About Genous

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.

About OrbusNeich

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.


'/>"/>
SOURCE OrbusNeich
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. OrbusNeichs Genous(TM) Bio-engineered R stent(TM) is Feasible in Patients Requiring Undeferrable Non-Cardiac Surgery, International Journal of Cardiology Publication Reports
2. OrbusNeichs Genous(TM) Bio-engineered R stent(TM) Demonstrates Impressive Results in Higher Risk Patients
3. Interim Analysis of Data from e-HEALING Registry of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) to be Presented at AHA Scientific Sessions 2008
4. OrbusNeichs Genous(TM) Bio-Engineered R Stent(TM) is Feasible in Acute Myocardial Infarction Patients, American Heart Journal Paper Reports
5. New and Interesting PROSTVAC(TM) Data Indicate Broad Therapeutic Use in Metastatic Prostate Cancer
6. Regado Biosciences Announces Allowance in Europe of a Fundamental Patent Broadly Covering Oligonucleotide Modulators to Blood Coagulation Factor Aptamers
7. Indian Stem Cell Trial to Broaden Diabetic Foot Inclusion Criteria
8. Mirus Bio Releases for Sale TransIT(R)-2020; a New Broad Spectrum, Animal-Free Transfection Reagent to Go Head to Head With FuGENE(R) HD and Lipofectamine(TM) 2000
9. NexBio(R) Demonstrates DAS181 (Fludase(R)*), a Broad-Spectrum Drug Candidate, Inhibits Influenza Viral Infection in Human Lung Tissue
10. Bion Announces Approval of New U.S. Patent that Broadens Protection for the Companys Livestock Waste Environmental Treatment Processes
11. DuPont and Bayer CropScience Expand Collaboration With Broad License Agreements
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... PHILADELPHIA , June 27, 2016  Liquid ... today announced the funding of a Sponsored Research ... study circulating tumor cells (CTCs) from cancer patients.  ... changes in CTC levels correlate with clinical outcomes ... therapies. These data will then be employed to ...
(Date:6/24/2016)... ... , ... While the majority of commercial spectrophotometers and fluorometers use the z-dimension ... are higher end machines that use the more unconventional z-dimension of 20mm. Z-dimension ... bottom of the cuvette holder. , FireflySci has developed several Agilent flow cell ...
(Date:6/23/2016)... CAMBRIDGE, Mass. , June 23, 2016 /PRNewswire/ ... the development of novel compounds designed to target ... compound, napabucasin, has been granted Orphan Drug Designation ... in the treatment of gastric cancer, including gastroesophageal ... cancer stemness inhibitor designed to inhibit cancer stemness ...
(Date:6/23/2016)... ... 23, 2016 , ... Charm Sciences, Inc. is pleased to ... AOAC Research Institute approval 061601. , “This is another AOAC-RI approval of the ... Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods perform comparably ...
Breaking Biology Technology:
(Date:5/16/2016)... NEW YORK , May 16, 2016   ... authentication solutions, today announced the opening of an IoT ... to strengthen and expand the development of embedded ... provides an unprecedented level of convenience and security with ... to authenticate one,s identity aside from DNA. EyeLock,s platform ...
(Date:4/28/2016)... 28, 2016 First quarter 2016:   ... compared with the first quarter of 2015 The gross ... M (loss: 18.8) and the operating margin was 40% (-13) ... Cash flow from operations was SEK 249.9 M (21.2) , ... is unchanged, SEK 7,000-8,500 M. The operating margin for ...
(Date:4/15/2016)... DUBLIN , April 15, 2016 ... of the,  "Global Gait Biometrics Market 2016-2020,"  report ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ,The global gait ... CAGR of 13.98% during the period 2016-2020. ... movement angles, which can be used to compute ...
Breaking Biology News(10 mins):