|By PR Newswire||
|May 27, 2013 03:00 AM EDT||
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.
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.
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 6, 2016 12:45 AM EST Reads: 795
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Dec. 6, 2016 12:30 AM EST Reads: 1,188
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
Dec. 6, 2016 12:30 AM EST Reads: 4,566
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Dec. 6, 2016 12:00 AM EST Reads: 848
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 10:30 PM EST Reads: 1,050
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and sh...
Dec. 5, 2016 08:45 PM EST Reads: 491
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Dec. 5, 2016 07:45 PM EST Reads: 2,224
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Dec. 5, 2016 07:45 PM EST Reads: 2,087
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these. In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effici...
Dec. 5, 2016 07:15 PM EST Reads: 5,052
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Dec. 5, 2016 07:15 PM EST Reads: 389
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
Dec. 5, 2016 05:45 PM EST Reads: 1,610
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Dec. 5, 2016 04:30 PM EST Reads: 2,062
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 5, 2016 04:15 PM EST Reads: 867
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 5, 2016 03:45 PM EST Reads: 4,257
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 5, 2016 03:45 PM EST Reads: 384
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
Dec. 5, 2016 02:45 PM EST Reads: 1,607
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Dec. 5, 2016 02:45 PM EST Reads: 693
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Dec. 5, 2016 02:45 PM EST Reads: 3,292
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 5, 2016 02:00 PM EST Reads: 2,216
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Dec. 5, 2016 01:45 PM EST Reads: 1,713