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:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
(Date:6/23/2016)... FRANKLIN, Tenn. , June 23, 2016 ... for automating, integrating and transforming the patient ... launch of several innovative new products and ... depth of its revenue cycle offerings. These ... establish more efficient workflows, remain compliant in ...
(Date:6/23/2016)... 2016  The National Pharmaceutical Council (NPC) today ... policy research organization as its newest member.  ... vice president and chief scientific officer, Mallinckrodt Pharmaceuticals, ... NPC Board of Directors. ... joined us in support of our efforts to ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a weight ... app plans to fix the two major problems leading the fitness industry today:, ... program , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... "With 30 ... their specific project," said Christina Austin - CEO of Pixel Film Studios. , ... and all within Final Cut Pro X . Simply select a ProHand generator ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Scientific Sessions in Dallas that it will receive two significant new grants to ... came as PHA marked its 25th anniversary by recognizing patients, medical professionals and ...
(Date:6/24/2016)... TX (PRWEB) , ... June 24, 2016 , ... People ... part in Genome magazine’s Code Talker Award, an essay contest in which patients and ... an award to be presented at the 2016 National Society of Genetic Counselors (NSGC) ...
Breaking Medicine News(10 mins):