Welcome!

News Feed Item

OrbusNeich Initiates HARMONEE Study in Japan to Evaluate the COMBO™ Dual Therapy Stent

Company Initiates Joint U.S. and Japanese Registration Trial

HONG KONG, Feb. 26, 2014 /PRNewswire/ -- OrbusNeich today announced that patient enrollment has been initiated in Japan in the pivotal clinical trial of the COMBO Dual Therapy Stent™ (COMBO Stent) employing a single Japan-U.S. protocol conducted as a Global Clinical Trial "proof-of-concept" under the framework of the joint Japan-U.S. Harmonization-By-Doing [HBD] initiative. The first patient was enrolled at Shonan Kamakura General Hospital, Japan, by Dr. Shigeru Saito, M.D., the vice director of the hospital and co-principal investigator of the study.

The randomized, multi-center HARMONEE (Harmonized Assessment by Randomized, Multi-center Study of OrbusNEich's COMBO StEnt) study is designed to enroll 572 patients at up to 50 sites in Japan and the U.S. to support the company's planned application for Shonin approval in Japan and to meet the Pilot trial requirements in the U.S. Patients presenting with ischemic coronary disease and non-ST segment myocardial infarction (NSTEMI) will be randomized one-to-one to treatment with a COMBO Stent or an everolimus-eluting stent (EES) comparator.  The study's primary endpoint is a comparison of clinically driven target vessel failure (TVF), defined as cardiac death, target vessel myocardial infarction (MI) or ischemia-driven target vessel revascularization (TVR) by percutaneous or surgical methods. All patients will undergo fractional flow reserve (FFR) or angiography to determine ischemia-driven TVR.

"This registration trial is an important milestone for interventional cardiologists and patients in Japan," said Dr. Saito. "The study will investigate the clinical performance of the groundbreaking COMBO Stent, which combines drug eluting technology for control of neointimal proliferation along with EPC capture technology for promoting early endothelialization. Furthermore, this trial design innovates on the traditional framework for clinical trials using a unique Japan-U.S. collaboration, such that one can say that the first step to "creating the future" has just been taken."

The HARMONEE study design consists of three cohorts, each with equal number of patients receiving either the COMBO Stent or the control stent. The first cohort includes 30 patients who will undergo assessment by FFR and quantitative coronary angiography (QCA) at 12 months and optical coherence tomography (OCT) at six and 12 months. The second cohort consists of 110 patients who will undergo assessment by FFR, QCA and OCT at 12 months. The third cohort of 432 patients will undergo assessment by FFR and QCA at 12 months.

Mitchell Krucoff, M.D., of Duke University Medical Center, Durham, N.C., and study co-principal investigator, said, "The Japan-U.S. HARMONEE study is very exciting for the future of patient care and of clinical trials treating coronary disease. While the field of drug eluting stents is mature, the HARMONEE study breaks new ground with many important "firsts." This is the first four-component drug eluting stent to seek registration, combining healthier stent-site healing through biological capture of circulating endothelial progenitor cells to other "best in class" safety features such as sirolimus elution through abluminal coated, bioabsorbable polymer. And this is the first pivotal stent study where co-enrollment in both Japan and the U.S. will help bring forward this new device in both nations through regulatory harmonization. Finally, this is the first stent study using both physiologic and anatomic assessment of the long-term result, as well as high resolution imaging of endothelial recovery. This is certainly not "just another" stent study!"

About the COMBO Dual Therapy Stent

The COMBO Dual Therapy Stent is the first dual therapy stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of the proven pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.

OrbusNeich's patented endothelial progenitor cell (EPC) capture technology 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 captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

The COMBO Dual Therapy Stent has received CE Mark approval in Europe.  The COMBO Stent is an investigational device and not available for sale in Japan and the U.S.

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 dual therapy stent, the COMBO Dual Therapy Stent, and the world's first pro-healing stent, the Genous™ Stent. Other products include stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.

Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich, and learn more about the company and its innovative technology on OrbusNeich's YouTube Channel: http://www.youtube.com/user/OrbusNeichMedia.

SOURCE OrbusNeich

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
There's no doubt that blockchain technology is a powerful tool for the enterprise, but bringing it mainstream has not been without challenges. As VP of Technology at 8base, Andrei is working to make developing a blockchain application accessible to anyone. With better tools, entrepreneurs and developers can work together to quickly and effectively launch applications that integrate smart contracts and blockchain technology. This will ultimately accelerate blockchain adoption on a global scale.
DXWorldEXPO LLC announced today that Nutanix has been named "Platinum Sponsor" of CloudEXPO | DevOpsSUMMIT | DXWorldEXPO New York, which will take place November 12-13, 2018 in New York City. Nutanix makes infrastructure invisible, elevating IT to focus on the applications and services that power their business. The Nutanix Enterprise Cloud Platform blends web-scale engineering and consumer-grade design to natively converge server, storage, virtualization and networking into a resilient, softwar...
Despite being the market leader, we recognized the need to transform and reinvent our business at Dynatrace, before someone else disrupted the market. Over the course of three years, we changed everything - our technology, our culture and our brand image. In this session we'll discuss how we navigated through our own innovator's dilemma, and share takeaways from our experience that you can apply to your own organization.
Founded in 2002 and headquartered in Chicago, Nexum® takes a comprehensive approach to security. Nexum approaches business with one simple statement: “Do what’s right for the customer and success will follow.” Nexum helps you mitigate risks, protect your data, increase business continuity and meet your unique business objectives by: Detecting and preventing network threats, intrusions and disruptions Equipping you with the information, tools, training and resources you need to effectively m...
Having been in the web hosting industry since 2002, dhosting has gained a great deal of experience while working on a wide range of projects. This experience has enabled the company to develop our amazing new product, which they are now excited to present! Among dHosting's greatest achievements, they can include the development of their own hosting panel, the building of their fully redundant server system, and the creation of dhHosting's unique product, Dynamic Edge.
The Transparent Cloud-computing Consortium (T-Cloud) is a neutral organization for researching new computing models and business opportunities in IoT era. In his session, Ikuo Nakagawa, Co-Founder and Board Member at Transparent Cloud Computing Consortium, will introduce the big change toward the "connected-economy" in the digital age. He'll introduce and describe some leading-edge business cases from his original points of view, and discuss models & strategies in the connected-economy. Nowad...
"DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great team at @DevOpsSUMMIT and CloudEXPO tell the world how they can leverage this emerging disruptive trend."
For far too long technology teams have lived in siloes. Not only physical siloes, but cultural siloes pushed by competing objectives. This includes informational siloes where business users require one set of data and tech teams require different data. DevOps intends to bridge these gaps to make tech driven operations more aligned and efficient.
NanoVMs is the only production ready unikernel infrastructure solution on the market today. Unikernels prevent server intrusions by isolating applications to one virtual machine with no users, no shells and no way to run other programs on them. Unikernels run faster and are lighter than even docker containers.
CloudEXPO | DevOpsSUMMIT | DXWorldEXPO Silicon Valley 2019 will cover all of these tools, with the most comprehensive program and with 222 rockstar speakers throughout our industry presenting 22 Keynotes and General Sessions, 250 Breakout Sessions along 10 Tracks, as well as our signature Power Panels. Our Expo Floor will bring together the leading global 200 companies throughout the world of Cloud Computing, DevOps, IoT, Smart Cities, FinTech, Digital Transformation, and all they entail. As ...
Darktrace is the world's leading AI company for cyber security. Created by mathematicians from the University of Cambridge, Darktrace's Enterprise Immune System is the first non-consumer application of machine learning to work at scale, across all network types, from physical, virtualized, and cloud, through to IoT and industrial control systems. Installed as a self-configuring cyber defense platform, Darktrace continuously learns what is ‘normal' for all devices and users, updating its understa...
Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of business. Only 12% still survive. Similar percentages are found throughout enterprises of all sizes. We are offering early bird savings...
SUSE is a German-based, multinational, open-source software company that develops and sells Linux products to business customers. Founded in 1992, it was the first company to market Linux for the enterprise. Founded in 1992, SUSE is the world’s first provider of an Enterprise Linux distribution. Today, thousands of businesses worldwide rely on SUSE for their mission-critical computing and IT management needs.
The dream is universal: heuristic driven, global business operations without interruption so that nobody has to wake up at 4am to solve a problem. Building upon Nutanix Acropolis software defined storage, virtualization, and networking platform, Mark will demonstrate business lifecycle automation with freedom of choice and consumption models. Hybrid cloud applications and operations are controllable by the Nutanix Prism control plane with Calm automation, which can weave together the following: ...
Crosscode Panoptics Automated Enterprise Architecture Software. Application Discovery and Dependency Mapping. Automatically generate a powerful enterprise-wide map of your organization's IT assets down to the code level. Enterprise Impact Assessment. Automatically analyze the impact, to every asset in the enterprise down to the code level. Automated IT Governance Software. Create rules and alerts based on code level insights, including security issues, to automate governance. Enterpr...