|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.
A completely new computing platform is on the horizon. They’re called Microservers by some, ARM Servers by others, and sometimes even ARM-based Servers. No matter what you call them, Microservers will have a huge impact on the data center and on server computing in general. Although few people are familiar with Microservers today, their impact will be felt very soon. This is a new category of computing platform that is available today and is predicted to have triple-digit growth rates for some ...
Oct. 21, 2016 10:00 PM EDT Reads: 33,886
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Oct. 21, 2016 10:00 PM EDT Reads: 4,197
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Oct. 21, 2016 09:30 PM EDT Reads: 614
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU’s GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes.
Oct. 21, 2016 09:30 PM EDT Reads: 1,578
SYS-CON Events announced today that Roundee / LinearHub will exhibit at the WebRTC Summit at @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LinearHub provides Roundee Service, a smart platform for enterprise video conferencing with enhanced features such as automatic recording and transcription service. Slack users can integrate Roundee to their team via Slack’s App Directory, and '/roundee' command lets your video conference ...
Oct. 21, 2016 09:15 PM EDT Reads: 1,975
SYS-CON Events announced today that Enzu will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to focus on the core of their online busine...
Oct. 21, 2016 09:15 PM EDT Reads: 1,189
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and...
Oct. 21, 2016 08:15 PM EDT Reads: 323
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Oct. 21, 2016 07:15 PM EDT Reads: 1,608
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining senso...
Oct. 21, 2016 07:15 PM EDT Reads: 241
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
Oct. 21, 2016 07:00 PM EDT Reads: 8,103
"Matrix is an ambitious open standard and implementation that's set up to break down the fragmentation problems that exist in IP messaging and VoIP communication," explained John Woolf, Technical Evangelist at Matrix, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Oct. 21, 2016 07:00 PM EDT Reads: 8,924
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, discussed how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technologi...
Oct. 21, 2016 06:45 PM EDT Reads: 2,813
What are the new priorities for the connected business? First: businesses need to think differently about the types of connections they will need to make – these span well beyond the traditional app to app into more modern forms of integration including SaaS integrations, mobile integrations, APIs, device integration and Big Data integration. It’s important these are unified together vs. doing them all piecemeal. Second, these types of connections need to be simple to design, adapt and configure...
Oct. 21, 2016 06:45 PM EDT Reads: 1,857
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Oct. 21, 2016 06:15 PM EDT Reads: 3,014
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Oct. 21, 2016 05:15 PM EDT Reads: 2,814