Navigation Links
Interim Analysis of 12-Month Data from e-HEALING Registry Shows Good Safety and Efficacy in Real-World Use of OrbusNeich's Genous(TM) Bio-engineered R stent(TM)

Additional Data Presentation Shows Encouraging 12-Month Outcomes from Single- Center Study Involving Patients with Predominantly Complex Lesions

WASHINGTON, Oct. 14 /PRNewswire/ -- OrbusNeich today announced that an interim analysis of 12-month follow-up data from the global e-HEALING registry show good safety and efficacy in the real-world use of the company's Genous Bio-engineered R stent.

Presented by Professor Robbert de Winter, M.D., Ph.D., of the Academic Medical Center in Amsterdam at the Transcatheter Cardiovascular Therapeutics symposium, TCT 2008, in Washington, D.C., the data from 3,200 patients were a target lesion revascularization (TLR) rate of 5%, a subacute thrombosis (SAT) rate of 0.4%, a late stent thrombosis (LST) rate of 0.3%, and a major adverse cardiac events (MACE) rate of 8.5%.

"The data further support the use of Genous as an alternative to drug- eluting stents, especially in light of the relatively minimal dual- antiplatelet therapy requirements with the stent," said de Winter, a co- principal investigator of the study. "Patient compliance with extended dual- antiplatelet therapy due to cost and other factors such as patients facing imminent non-cardiac surgery are issues that we can address by using Genous."

OrbusNeich's e-HEALING clinical study is a multi-center, worldwide (outside the United States) prospective registry with 5,000 enrolled patients treated with the Genous Bio-engineered R stent. The study protocol recommends that patients receive one month of clopidogrel treatment after the procedure. Clinical follow-up takes place at 30 days, six months and 12 months. The primary endpoint of the registry is target vessel failure at 12 months.

In a related presentation at TCT 2008, de Winter and his colleagues reported data from the Academic Medical Center's single-center, real-world study of the Genous stent in patients with predominantly complex lesions. The data, presented in an electronic poster, show a good one-year clinical outcome regarding major adverse cardiac events, including a low incidence of stent thrombosis.

In the study, 236 patients were treated with Genous and completed 12-month follow-up. For the lesions treated, 64% were type B2 or C, 16% were chronic total occlusion, and 23% were bifurcated. The TLR rate was 8.1%, and the MACE rate was 13.6%. There was one patient with acute stent thrombosis at 24 hours, two patients with SAT at seven and 18 days, and no LST observed.

Unlike drug-eluting stents, Genous, which is coated with an antibody, captures a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process. EPCs circulate in the bloodstream and are involved in the repair of blood vessels. When attracted to the surface of Genous, EPCs rapidly form an endothelial layer over the stent that provides protection against thrombus and minimizes restenosis.

OrbusNeich designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. The company's product portfolio includes the Genous Bio-engineered R stent, an antibody-coated device that is the first-ever stent to capture a patient's endothelial progenitor cells (EPCs) to accelerate the natural healing process following placement. Other products are stents, balloons and guiding catheters marketed under the names of Blazer(TM), R stent(TM), Scoreflex(TM), Sapphire(TM), Sapphire(TM) NC, Avita(TM), Avita HP(TM), SafeCut(TM), Lumina(TM) and Saffron.

A global company, OrbusNeich is headquartered in Hong Kong and has operations in Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; Tokyo; and Shenzhen, China. OrbusNeich, which has provided cardiology devices to physicians through its predecessor companies since 1979, today supplies products to interventional cardiologists in more than 60 countries. For more information, visit

Editor's Notes:

The data presentations listed in this news release are available on OrbusNeich's Web site, which is located at

OrbusNeich is displaying the Genous Bio-engineered R stent and other products at booth No. 1011 at TCT 2008.

Product images are available on request.

SOURCE OrbusNeich
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial
2. Dendreon to Hold a Conference Call Today at 9:00 AM ET to Provide an Update on Interim Results of Phase 3 PROVENGE IMPACT Trial
3. Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study
4. Fralex provides update on timing of interim analysis results
5. BioView Reports Interim Results of Early Detection Lung Cancer Diagnostic Test
6. Xoft Showcases Interim Clincal Results for Breast Cancer Product and New Indications for Electronic Brachytherapy(eBx) at Astro Meeting
7. Epiphany Biosciences to Continue Phase 2 Shingles Study After Interim Analysis; Plans Follow-On Clinical Trial Studying Post-Herpetic Neuralgia (PHN)
8. Simcere Pharmaceutical Group Announces Interim Results of Endu Phase IV Clinical Study
9. Neurobiological Technologies Reaches Patient Enrollment Target For Interim Analysis of Viprinex(TM) Phase 3 Stroke Trials
10. Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October
11. Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program
Post Your Comments:
(Date:10/12/2017)... DIEGO , Oct. 12, 2017   Divoti USA ... Alert Jewelry up to the standard of the latest FDA requirements, ... June 2017). Anyone in need of Medical ID jewelry ... Medical Alert Jewelry are engraved in terms of the ... Divoti ...
(Date:10/11/2017)... Texas , Oct. 11, 2017  True ... services, has amplified its effort during National Breast ... about hereditary cancer risks. ... of Clinical Oncology calculated that more than 10 ... have inherited mutations in BRCA1 or BRCA2 and have ...
(Date:10/7/2017)... 6, 2017   Provista, a proven leader ... billion in purchasing power, today announced a new resource ... The Newsroom is the online home for case ... expert bios, news releases, slideshows and events. ... wealth of resources at their fingertips, viewers can also ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... locations throughout Arkansas that offers insurance and financial preparation services, is providing an ... Rock City Rescue organization. , Rock City Rescue is a locally recognized nonprofit ...
(Date:10/13/2017)... PITTSBURGH, Pa. (PRWEB) , ... October 13, 2017 , ... ... the dark poses a problem. Fortunately, an inventor from Austin, Texas, has identified a ... access to medication in darkness or restricted lighting. As such, it eliminates the need ...
(Date:10/13/2017)... ... 13, 2017 , ... The International Association of Eating Disorders ... for the field of eating disorders, announces the opening of early registration for ... Florida at the Omni Resort at ChampionsGate. , The annual iaedp™ ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate ... primary prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton ... staged a mock evacuation of the facility as part of a disaster drill on ... Echo Hose EMS and Shelton City Emergency Manager, as well as the Connecticut ...
Breaking Medicine News(10 mins):