Welcome!

Agile Computing Authors: Larry Alton, Pat Romanski, Elizabeth White, Yeshim Deniz, Astadia CloudGPS

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 DXWorldExpo has been named “Global Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Digital Transformation is the key issue driving the global enterprise IT business. Digital Transformation is most prominent among Global 2000 enterprises and government institutions.
SYS-CON Events announced today that Nihon Micron will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Nihon Micron Co., Ltd. strives for technological innovation to establish high-density, high-precision processing technology for providing printed circuit board and metal mount RFID tags used for communication devices. For more inf...
SYS-CON Events announced today that Ryobi Systems will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Ryobi Systems Co., Ltd., as an information service company, specialized in business support for local governments and medical industry. We are challenging to achive the precision farming with AI. For more information, visit http:...
SYS-CON Events announced today that mruby Forum will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. mruby is the lightweight implementation of the Ruby language. We introduce mruby and the mruby IoT framework that enhances development productivity. For more information, visit http://forum.mruby.org/.
SYS-CON Events announced today that Mobile Create USA will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Mobile Create USA Inc. is an MVNO-based business model that uses portable communication devices and cellular-based infrastructure in the development, sales, operation and mobile communications systems incorporating GPS capabi...
SYS-CON Events announced today that Daiya Industry will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Daiya Industry specializes in orthotic support systems and assistive devices with pneumatic artificial muscles in order to contribute to an extended healthy life expectancy. For more information, please visit https://www.daiyak...
SYS-CON Events announced today that Fusic will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Fusic Co. provides mocks as virtual IoT devices. You can customize mocks, and get any amount of data at any time in your test. For more information, visit https://fusic.co.jp/english/.
SYS-CON Events announced today that Keisoku Research Consultant Co. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Keisoku Research Consultant, Co. offers research and consulting in a wide range of civil engineering-related fields from information construction to preservation of cultural properties. For more information, vi...
SYS-CON Events announced today that MIRAI Inc. will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MIRAI Inc. are IT consultants from the public sector whose mission is to solve social issues by technology and innovation and to create a meaningful future for people.
SYS-CON Events announced today that Interface Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Interface Corporation is a company developing, manufacturing and marketing high quality and wide variety of industrial computers and interface modules such as PCIs and PCI express. For more information, visit http://www.i...
Elon Musk is among the notable industry figures who worries about the power of AI to destroy rather than help society. Mark Zuckerberg, on the other hand, embraces all that is going on. AI is most powerful when deployed across the vast networks being built for Internets of Things in the manufacturing, transportation and logistics, retail, healthcare, government and other sectors. Is AI transforming IoT for the good or the bad? Do we need to worry about its potential destructive power? Or will we...
SYS-CON Events announced today that Enroute Lab will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enroute Lab is an industrial design, research and development company of unmanned robotic vehicle system. For more information, please visit http://elab.co.jp/.
In his session at @ThingsExpo, Greg Gorman is the Director, IoT Developer Ecosystem, Watson IoT, will provide a short tutorial on Node-RED, a Node.js-based programming tool for wiring together hardware devices, APIs and online services in new and interesting ways. It provides a browser-based editor that makes it easy to wire together flows using a wide range of nodes in the palette that can be deployed to its runtime in a single-click. There is a large library of contributed nodes that help so...
DevOps at Cloud Expo – being held October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real r...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, will discuss how data centers of the future will be managed, how th...
SYS-CON Events announced today that Massive Networks, that helps your business operate seamlessly with fast, reliable, and secure internet and network solutions, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. As a premier telecommunications provider, Massive Networks is headquartered out of Louisville, Colorado. With years of experience under their belt, their team of...
SYS-CON Events announced today that TMC has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo and Big Data at Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Global buyers rely on TMC’s content-driven marketplaces to make purchase decisions and navigate markets. Learn how we can help you reach your marketing goals.
There is huge complexity in implementing a successful digital business that requires efficient on-premise and cloud back-end infrastructure, IT and Internet of Things (IoT) data, analytics, Machine Learning, Artificial Intelligence (AI) and Digital Applications. In the data center alone, there are physical and virtual infrastructures, multiple operating systems, multiple applications and new and emerging business and technological paradigms such as cloud computing and XaaS. And then there are pe...
Real IoT production deployments running at scale are collecting sensor data from hundreds / thousands / millions of devices. The goal is to take business-critical actions on the real-time data and find insights from stored datasets. In his session at @ThingsExpo, John Walicki, Watson IoT Developer Advocate at IBM Cloud, will provide a fast-paced developer journey that follows the IoT sensor data from generation, to edge gateway, to edge analytics, to encryption, to the IBM Bluemix cloud, to Wa...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.