Navigation Links
Randomized Clinical Trial of OrbusNeich's Genous™ Bio-engineered R stent™ in China Completes Patient Enrollment
Date:10/11/2010

HONG KONG, Oct. 11 /PRNewswire/ -- OrbusNeich today reported the completion of patient enrollment in a randomized clinical study of its Genous Bio-engineered R stent at 11 sites in China.

The primary objective of the 180 patient, controlled study is to demonstrate the safety and effectiveness of the Genous Bio-engineered R stent compared to the Medtronic Endeavor® Sprint stent in patients with symptoms of angina or myocardial ischemia. The primary endpoints are difference in Major Adverse Cardiac Event (MACE) rates between the two groups at 12 months after implantation and 270 day angiographic Late Loss (LL). Patients enrolled in the study were split evenly between the control and test arms.

"Based on its unique design and healing technology, we believe that Genous has the potential to give physicians an additional option for treating patients," said Prof. Lu Shuzheng from Anzhen Hospital, principal investigator of the trial. "We are excited to complete enrollment in this study, which may bring further clinical support for the technology's use in China."

David Chien, vice chairman of OrbusNeich, added, "This first clinical study of Genous in China is significant in the full development of the technology. We look forward to seeing additional clinical support for the use of Genous in challenging cases, such as diabetic patients and those who cannot tolerate a year of dual antiplatelet therapy."

Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, in-stent thrombosis, MACE rates at 30, 60, 90, 180 and 270 days, as well as clinically driven Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR) and Target Lesion Failure (TLF) rates at 30, 60, 90, 180, 270 and 360 days.  

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 other stents and balloons marketed under the names of Blazer™, R stent, Scoreflex™, Sapphire™, and Sapphire NC. Development stage products include the Combo™ Bio-engineered Sirolimus Eluting Stent, or Combo Stent, which combines the Genous pro-healing technology for rapid endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. 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©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Patient Enrollment Completed in First Randomized Clinical Study of OrbusNeichs Combo™ Bio-engineered Sirolimus Eluting Stent
2. National University Hospital Singapore Receives DSRB Approval to Use TIGR® Matrix Surgical Mesh in a New Randomized Controlled TRAM Flap Study
3. CorMatrix Receives FDA IDE Approval to Begin Prospective, Randomized Evaluation of New Onset Postoperative Atrial Fibrillation in Subjects Receiving the CorMatrix® ECM™ for Pericardial Closure
4. Randomized Controlled Trial Finds Masimo PVI Improves Fluid Management During Surgery
5. ANA598 Demonstrates SVR12 in 100% of First Group of HCV Patients Randomized to Stop All Treatment at Week 24
6. Ophthotech Enrolls Its First Patient in a Randomized, Controlled Phase II Study of E10030 in Macular Degeneration
7. OrbusNeich Announces First Patient Enrolled in Randomized Clinical Trial of Genous(TM) Bio-engineered R stent(TM) in China
8. Daiichi Sankyo Initiates Largest Single, Double-Blind, Randomized, Phase III Trial for Treatment and Prevention of Recurrent Venous Thromboembolism
9. LigoCyte Pharmaceuticals Initiates a Randomized, Double Blind, Placebo Controlled Norovirus Vaccine Study Including Live Virus Challenge
10. West Wireless Health Institute Teams with Corventis for its First Multicenter, Randomized Clinical Trial
11. Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... -- Caris Life Sciences ® , a leading innovator in ... medicine, today announced that St. Jude Medical Center,s Crosson ... as its 17 th member. Through participation with ... Institute will help develop standards of care and best ... cancer treatment more precise and effective. ...
(Date:10/7/2017)... Texas , Oct. 6, 2017   Provista, ... with more than $100 billion in purchasing power, today ... news and information. The Newsroom is the ... and industry trends, infographics, expert bios, news releases, slideshows ... having access to a wealth of resources at their ...
(Date:10/2/2017)... 2017 Diplomat Pharmacy, Inc. (NYSE: ... Consulting, LLC , and named its founder as Diplomat,s ... Tennessee , will operate under Diplomat ... service offerings for health care partners to include IT ... "In an interoperable world, technology delivers comprehensive ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important ... problem. Fortunately, an inventor from Austin, Texas, has identified a solution. , She developed ... darkness or restricted lighting. As such, it eliminates the need to turn on a ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder of ... ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership in ... It also provides a forum to network with elder law attorneys nationwide,” said Somekh. ...
(Date:10/13/2017)... ... 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at ... towards children of all ages; it is a non-competitive, non-timed event, which is all ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: ... “America On The Brink” is the creation of published author, William Nowers. ... As a WWII veteran, he spent thirty years in the Navy. Following ...
(Date:10/12/2017)... ... , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s ... design of the shoulder pad. The shoulder pad provides optimal support and full ... while using cold therapy. By utilizing ice and water that is circulated from an ...
Breaking Medicine News(10 mins):