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)
Date:10/14/2008

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 http://www.OrbusNeich.com.

Editor's Notes:

The data presentations listed in this news release are available on OrbusNeich's Web site, which is located at http://www.orbusneich.com.

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:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... 23, 2017   Icertis , the leading ... the cloud, today announced an upgrade to the ... to improve clinical trials contract management. Built on ... the solution speeds up clinical trial contracting while ... (CRO). "The pharmaceutical industry is ...
(Date:3/23/2017)... March 23, 2017 A research report ... is expected to reach USD 7.2 billion by the end ... preparation is a procedure in which a sample is preserved ... most analytical procedures since the methods are often allowing repeated ... of the most shared procedures in the lab. In many ...
(Date:3/23/2017)... , March 23, 2017 Ascendis Pharma A/S ... TransCon technology to address significant unmet medical needs in ... a conference call and webcast on Monday, April 3 ... Society in Orlando, Florida , to ... candidates (TransCon Growth Hormone, TransCon PTH and TransCon CNP). ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... ... families and businesses of the Norwalk and Vermillion areas, celebrates the newest ... (N.O.R.A.) is a nonprofit, community-based substance abuse prevention and peer recovery support ...
(Date:3/23/2017)... ... March 23, 2017 , ... Benefits delivery trailblazer, Hodges-Mace, ... and centralized benefits dashboard solving one of the top frustrations in employee benefits ... the first time, employees can access up-to-date information and account balances for all ...
(Date:3/23/2017)... ... March 23, 2017 , ... Hakim Unique Group ... technology company California Healthcom Group (CHG). , The HUG investment is a ... headquarters in California, CHG is a growing, internationally recognized healthcare management, technology, and ...
(Date:3/23/2017)... Scottsdale, AZ (PRWEB) , ... March 23, 2017 , ... ... helping people around the world to manage stress and anxiety. , “Buzzies change ... Serin, neuropsychologist, inventor and co-founder of Buzzies. , Since its launch date in December ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... a new solution that enables organizations to easily reprint customer invoices, bills, statements ... Server’ automates all of the steps needed to retrieve and print the documents ...
Breaking Medicine News(10 mins):