|By PR Newswire||
|February 26, 2014 04:00 AM EST||
-- 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.
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.
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
May. 30, 2015 02:00 AM EDT Reads: 6,185
Collecting data in the field and configuring multitudes of unique devices is a time-consuming, labor-intensive process that can stretch IT resources. Horan & Bird [H&B], Australia’s fifth-largest Solar Panel Installer, wanted to automate sensor data collection and monitoring from its solar panels and integrate the data with its business and marketing systems. After data was collected and structured, two major areas needed to be addressed: improving developer workflows and extending access to a b...
May. 30, 2015 01:00 AM EDT Reads: 2,007
When an enterprise builds a hybrid IaaS cloud connecting its data center to one or more public clouds, security is often a major topic along with the other challenges involved. Security is closely intertwined with the networking choices made for the hybrid cloud. Traditional networking approaches for building a hybrid cloud try to kludge together the enterprise infrastructure with the public cloud. Consequently this approach requires risky, deep "surgery" including changes to firewalls, subnets...
May. 30, 2015 12:00 AM EDT Reads: 4,255
Move from reactive to proactive cloud management in a heterogeneous cloud infrastructure. In his session at 16th Cloud Expo, Manoj Khabe, Innovative Solution-Focused Transformation Leader at Vicom Computer Services, Inc., will show how to replace a help desk-centric approach with an ITIL-based service model and service-centric CMDB that’s tightly integrated with an event and incident management platform. Learn how to expand the scope of operations management to service management. He will al...
May. 29, 2015 11:45 PM EDT Reads: 1,496
SYS-CON Events announced today that BMC will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BMC delivers software solutions that help IT transform digital enterprises for the ultimate competitive business advantage. BMC has worked with thousands of leading companies to create and deliver powerful IT management services. From mainframe to cloud to mobile, BMC pairs high-speed digital innovation with robust...
May. 29, 2015 11:15 PM EDT Reads: 1,022
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
May. 29, 2015 09:00 PM EDT Reads: 4,993
2015 predictions circa 1970: houses anticipate our needs and adapt, city infrastructure is citizen and situation aware, office buildings identify and preprocess you. Today smart buildings have no such collective conscience, no shared set of fundamental services to identify, predict and synchronize around us. LiveSpace and M2Mi are changing that. LiveSpace Smart Environment devices deliver over the M2Mi IoT Platform real time presence, awareness and intent analytics as a service to local connecte...
May. 29, 2015 04:27 PM EDT Reads: 517
High-performing enterprise Software Quality Assurance (SQA) teams validate systems that are ready for use - getting most actively involved as components integrate and form complete systems. These teams catch and report on defects, making sure the customer gets the best software possible. SQA teams have leveraged automation and virtualization to execute more thorough testing in less time - bringing Dev and Ops together, ensuring production readiness. Does the emergence of DevOps mean the end of E...
May. 29, 2015 04:00 PM EDT Reads: 5,319
Amazon and Google have built software-defined data centers (SDDCs) that deliver massively scalable services with great efficiency. Yet, building SDDCs has proven to be a near impossibility for companies without hyper-scale resources. In his session at 15th Cloud Expo, David Cauthron, CTO and Founder of NIMBOXX, highlighted how a mid-sized manufacturer of global industrial equipment bridged the gap from virtualization to software-defined services, streamlining operations and costs while connect...
May. 29, 2015 04:00 PM EDT Reads: 3,366
Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...
May. 29, 2015 03:45 PM EDT Reads: 871
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, ...
May. 29, 2015 03:45 PM EDT Reads: 4,811
paradigm shifts in networking, to cloud and licensure, and all the Internet of Things in between. In 2014 automation was the name of the game. In his session at DevOps Summit, Matthew Joyce, a Sales Engineer at Big Switch, will discuss why in 2015 it’s complexity reduction. Matthew Joyce, a sales engineer at Big Switch, is helping push networking into the 21st century. He is also a hacker at NYC Resistor. Previously he worked at NASA Ames Research Center with the Nebula Project (where OpenSta...
May. 29, 2015 03:21 PM EDT Reads: 559
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
May. 29, 2015 03:00 PM EDT Reads: 4,945
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists will address the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affec...
May. 29, 2015 03:00 PM EDT Reads: 1,507
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In this session, James Kirkland, Red Hat's Chief Architect for the ...
May. 29, 2015 02:33 PM EDT Reads: 559