Welcome!

Web 2.0 Authors: Liz McMillan, Carmen Gonzalez, Pat Romanski, Yeshim Deniz, Rick Delgado

News Feed Item

OrbusNeich Launches World's First Dual Therapy Stent That Addresses Challenges of Delayed Coronary Artery Healing Associated with Monotherapy Drug Eluting Stents

Company Receives CE Mark for COMBO Dual Therapy Stent™; Introduces Product in Europe and Markets in Asia Pacific and Middle East Regions

HONG KONG, May 27, 2013 /PRNewswire/ -- OrbusNeich today launched the world's first dual therapy stent – the COMBO Dual Therapy Stent – to address the challenges of delayed healing of the coronary artery associated with monotherapy drug eluting stents (DES), the current standard of care for the treatment of coronary artery disease (CAD). The introduction of the COMBO Stent is in conjunction with the company's receipt of a CE Mark for the product and involves a sales roll-out in Europe and selected markets in the Asia Pacific and Middle East regions.

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

"The COMBO Dual Therapy Stent is the next wave of drug eluting stent technology," said Al Novak, OrbusNeich's chairman and CEO. "The dual therapy approach maintains the efficacy of monotherapy drug eluting stents while providing the benefits of accelerated stent endothelialization and healing. At OrbusNeich, we believe that minimizing restenosis in the near term and maximizing healing in the long term are of equal importance. Interventional cardiologists now have a no-compromise solution that offers both. With CE Mark approval, the COMBO Dual Therapy Stent has set a new, rigorous standard for stent innovation."

Roxana Mehran, M.D., Mount Sinai Medical Center, said, "I believe that COMBO is the next-next-generation drug eluting stent, combining the anti-restenotic property of drug eluting stents with endothelial progenitor cell (EPC) capture, which is able to heal the surface of the stent. We're most excited about the possibility of actually having a stent for which you do not need prolonged dual antiplatelet therapy (DAPT), and I think that is the future. Obligatory, prolonged DAPT is no longer going to be the standard – we cannot accept that anymore. And so, we're looking for a safer stent, and I think this very unique and interesting platform has incredible promise."

Nine-month clinical outcomes from the REMEDEE study confirmed that the COMBO Stent is as effective as a monotherapy DES, with respect to in-stent late lumen loss at nine-month angiographic follow-up (News Release, Nov. 14, 2011). These data were used to support CE Mark approval for COMBO.

"Late stent thrombosis is still a concern for patients treated with monotherapy DES, leaving them dependent on a minimum of six months DAPT," said Michael Haude, M.D., director of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, and principal investigator of the REMEDEE trial. "We also know that cessation of DAPT is the single most significant predictor of stent thrombosis for these patients. If cessation of DAPT is necessary, the COMBO Stent may enable us to stop DAPT without causing a catastrophic event. Thus the COMBO Stent has the potential to bring the best of both worlds together, balancing safety and efficacy."

The antiproliferative property of DES is known to interfere with endothelialization and, consequently, to increase the risk for stent thrombosis (ST). The addition of OrbusNeich's proprietary pro-healing antibody surface coating provides protection against ST by capturing EPCs circulating in the blood to the device to form a functional endothelial layer.

"Studies have shown that drug eluting stents adversely impact endothelial proliferation, migration and function," said Renu Virmani, M.D., of the CVPath Institute Inc. in Gaithersburg, Md. "Conversely, EPCs have the ability to migrate to areas of vascular injury and aid in the regeneration of damaged and dysfunctional endothelium. By combining drug elution with the EPC capture technology, the COMBO Stent may restore endothelial function. In addition, the COMBO Stent is the only stent with full and complete polymer degradation within 90 days, affording it the safety profile of a bare metal stent with the added benefit of allowing healing while suppressing smooth muscle cell proliferation."

Stephen M. Rowland, Ph.D., vice president of research and development at OrbusNeich, said, "COMBO was designed to address the limitations of DES monotherapy associated with delayed or impaired healing. With this new technology, we have a stent that combines sustained control of smooth cell proliferation with accelerated vascular healing driven by our EPC capture technology."

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 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.

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 pro-healing stent, the Genous™ Stent, and the world's first dual therapy stent, the COMBO Dual Therapy 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.

@ThingsExpo Stories
SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue business and deliver exceptional experiences to their customers.
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce the value of the network in helping organizations to maximize their company’s cloud experience.

SUNNYVALE, Calif., Oct. 20, 2014 /PRNewswire/ -- Spansion Inc. (NYSE: CODE), a global leader in embedded systems, today added 96 new products to the Spansion® FM4 Family of flexible microcontrollers (MCUs). Based on the ARM® Cortex®-M4F core, the new MCUs boast a 200 MHz operating frequency and support a diverse set of on-chip peripherals for enhanced human machine interfaces (HMIs) and machine-to-machine (M2M) communications. The rich set of periphera...

The Internet of Things (IoT) is making everything it touches smarter – smart devices, smart cars and smart cities. And lucky us, we’re just beginning to reap the benefits as we work toward a networked society. However, this technology-driven innovation is impacting more than just individuals. The IoT has an environmental impact as well, which brings us to the theme of this month’s #IoTuesday Twitter chat. The ability to remove inefficiencies through connected objects is driving change throughout every sector, including waste management. BigBelly Solar, located just outside of Boston, is trans...
SYS-CON Events announced today that Matrix.org has been named “Silver Sponsor” of Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Matrix is an ambitious new open standard for open, distributed, real-time communication over IP. It defines a new approach for interoperable Instant Messaging and VoIP based on pragmatic HTTP APIs and WebRTC, and provides open source reference implementations to showcase and bootstrap the new standard. Our focus is on simplicity, security, and supporting the fullest feature set.
Predicted by Gartner to add $1.9 trillion to the global economy by 2020, the Internet of Everything (IoE) is based on the idea that devices, systems and services will connect in simple, transparent ways, enabling seamless interactions among devices across brands and sectors. As this vision unfolds, it is clear that no single company can accomplish the level of interoperability required to support the horizontal aspects of the IoE. The AllSeen Alliance, announced in December 2013, was formed with the goal to advance IoE adoption and innovation in the connected home, healthcare, education, aut...
SYS-CON Events announced today that Red Hat, the world's leading provider of open source solutions, will exhibit at Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Red Hat is the world's leading provider of open source software solutions, using a community-powered approach to reliable and high-performing cloud, Linux, middleware, storage and virtualization technologies. Red Hat also offers award-winning support, training, and consulting services. As the connective hub in a global network of enterprises, partners, a...
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked for their ability to explore the economic strategies that utility/cloud computing provides. Whether public, private, or in a hybrid form, clo...
Software AG helps organizations transform into Digital Enterprises, so they can differentiate from competitors and better engage customers, partners and employees. Using the Software AG Suite, companies can close the gap between business and IT to create digital systems of differentiation that drive front-line agility. We offer four on-ramps to the Digital Enterprise: alignment through collaborative process analysis; transformation through portfolio management; agility through process automation and integration; and visibility through intelligent business operations and big data.
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
Be Among the First 100 to Attend & Receive a Smart Beacon. The Physical Web is an open web project within the Chrome team at Google. Scott Jenson leads a team that is working to leverage the scalability and openness of the web to talk to smart devices. The Physical Web uses bluetooth low energy beacons to broadcast an URL wirelessly using an open protocol. Nearby devices can find all URLs in the room, rank them and let the user pick one from a list. Each device is, in effect, a gateway to a web page. This unlocks entirely new use cases so devices can offer tiny bits of information or simple i...
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, will address the big issues involving these technologies and, more important, the results they will achieve. How important are public, private, and hybrid cloud to the enterprise? How does one define Big Data? And how is the IoT tying all this together?
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce the value of the network in helping organizations to maximize their company’s cloud experience.
TechCrunch reported that "Berlin-based relayr, maker of the WunderBar, an Internet of Things (IoT) hardware dev kit which resembles a chunky chocolate bar, has closed a $2.3 million seed round, from unnamed U.S. and Switzerland-based investors. The startup had previously raised a €250,000 friend and family round, and had been on track to close a €500,000 seed earlier this year — but received a higher funding offer from a different set of investors, which is the $2.3M round it’s reporting."
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, data security and privacy.
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. Over the summer Gartner released its much anticipated annual Hype Cycle report and the big news is that Internet of Things has now replaced Big Data as the most hyped technology. Indeed, we're hearing more and more about this fascinating new technological paradigm. Every other IT news item seems to be about IoT and its implications on the future of digital busines...
Cultural, regulatory, environmental, political and economic (CREPE) conditions over the past decade are creating cross-industry solution spaces that require processes and technologies from both the Internet of Things (IoT), and Data Management and Analytics (DMA). These solution spaces are evolving into Sensor Analytics Ecosystems (SAE) that represent significant new opportunities for organizations of all types. Public Utilities throughout the world, providing electricity, natural gas and water, are pursuing SmartGrid initiatives that represent one of the more mature examples of SAE. We have s...
The Internet of Things needs an entirely new security model, or does it? Can we save some old and tested controls for the latest emerging and different technology environments? In his session at Internet of @ThingsExpo, Davi Ottenheimer, EMC Senior Director of Trust, will review hands-on lessons with IoT devices and reveal privacy options and a new risk balance you might not expect.
IoT is still a vague buzzword for many people. In his session at Internet of @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, will discuss the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. The presentation will also discuss how IoT is perceived by investors and how venture capitalist access this space. Other topics to discuss are barriers to success, what is new, what is old, and what the future may hold.
Swiss innovators dizmo Inc. launches its ground-breaking software, which turns any digital surface into an immersive platform. The dizmo platform seamlessly connects digital and physical objects in the home and at the workplace. Dizmo breaks down traditional boundaries between device, operating systems, apps and software, transforming the way users work, play and live. It supports orchestration and collaboration in an unparalleled way enabling any data to instantaneously be accessed on any surface, anywhere and made interactive. Dizmo brings fantasies as seen in Sci-fi movies such as Iro...