Navigation Links
OrbusNeich Announces First Patient Enrolled in Randomized Clinical Trial of Genous(TM) Bio-engineered R stent(TM) in China
Date:2/11/2010

HONG KONG, Feb. 11 /PRNewswire/ -- OrbusNeich today announced that the first patient has been enrolled in a randomized clinical trial of the Genous Bio-engineered R stent in China.

A multicenter, randomized, controlled study, the trial will enroll 180 patients split evenly between the control and test arms at 11 sites countrywide. The primary study objective is to demonstrate the safety and effectiveness of the Genous Bio-engineered R stent compared to the Medtronic Endeavor Sprint stent.  

The study population will consist of patients ages 18 to 75 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 following implant and 270 day angiographic Late Loss (LL). 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.  

The first patient was enrolled in the study at Beijing Chaoyang Hospital on December 8, 2009.

"We believe that the Genous Bio-engineered R stent will provide an excellent treatment option to patients who present challenging cases with standard drug eluting stents," said Prof. Lu Shuzheng from Anzhen Hospital, principal investigator of the trial.

Al Novak, OrbusNeich's chairman and CEO, added, "We are excited to take the Genous Bio-engineered R stent into this pivotal trial in China. We expect that clinical data from this study will show positive benefits for patients, including those who often encounter challenges with today's drug eluting stents."

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™, 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.  

SOURCE OrbusNeich

RELATED LINKS
http://www.OrbusNeich.com

'/>"/>

SOURCE OrbusNeich
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Enrollment Reaches 110 Patients in Investigator Initiated, Randomized Trial of OrbusNeichs Genous(TM) Bio-Engineered R Stent(TM)
2. OrbusNeichs Genous(TM) Bio-Engineered R Stent(TM) is Subject of Sessions on Innovation at TCT 2007
3. Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) and Boston Scientifics Taxus(R) Stent in Patients at High Risk of Restenosis
4. OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) has Lower MACE Rate than TAXUS(R) and CYPHER(R) Stents in Clinical Trial
5. Clinical Impact of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) is Subject of Symposium at 16th Annual Scientific Congress of Hong Kong College of Cardiology
6. Data from Randomized Pilot Study, Real-World Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) to be Presented in Symposium at EuroPCR 2008
7. Multiple Clinical Data Presentations at EuroPCR 2008 Support Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) as Safe Alternative to Drug-Eluting Stents
8. Data Presented at Annual Meeting of Japanese Society of Interventional Cardiology Demonstrate OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) Has Better Outcomes When Compared to Drug-Eluting Stents
9. Data From Multiple Clinical Trials of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) to be Presented at TCT 2008
10. Interim Analysis of 12-Month Data from e-HEALING Registry Shows Good Safety and Efficacy in Real-World Use of OrbusNeichs Genous(TM) Bio-engineered R stent(TM)
11. Long Term Data Presented at EuroPCR 2009 from Randomized Study Attest to Durability of Results of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) Compared to Drug-Eluting Stents
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)...   Montrium , an industry leader in ... IQPC Trial Master Files & Inspection Readiness Conference ... Clinical Services has selected eTMF Connect ... EastHORN, a leading European contract research organization (CRO), ... to enable greater collaboration with sponsors, improve compliance ...
(Date:9/19/2017)... a venture-backed medical device company developing a non-invasive, robotically assisted, platform therapy that uses pulsed ...   ... Jim Bertolina, ... Tom Tefft ... medical device executive Josh Stopek , PhD, who has led R&D and business development ...
(Date:9/12/2017)... and NEW YORK , Sept. 12, 2017   ... for global supply chains, has published the first annual edition of its ... of more than 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings ... 2016. ... CSR Risk & Performance Index ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated ... in breathing. Oral appliances can offer significant relief to about 75 percent of ...
(Date:10/12/2017)... ... , ... Asante, a nationally recognized health system in southern ... home health joint venture through an agreement, effective October 1, 2017, to create ... health company with Asante, delivering clinically integrated care, for the past eight years. ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
Breaking Medicine News(10 mins):