|By Marketwired .||
|April 4, 2014 03:00 AM EDT||
IRVINE, CA -- (Marketwired) -- 04/04/14 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received CE Mark for the advanced EDWARDS INTUITY Elite valve system. This next-generation, rapid deployment system facilitates smaller incisions in surgical aortic valve replacement (AVR) procedures, and is built upon extensive evidence supporting the durability of the Carpentier-Edwards PERIMOUNT heart valve design.
"We're encouraged by the introduction of heart valve technologies that are developed to facilitate a minimally invasive approach for the improved treatment of patients with aortic valve disease," said Prof. Michael Borger, M.D., Ph.D., associate director of the Department of Cardiac Surgery at the Leipzig Heart Center in Germany. "Our experience with the EDWARDS INTUITY platform has shown the ability to implant the valve through smaller incisions, with significantly reduced cross-clamp time and improved hemodynamics. This less-invasive, more efficient surgical approach should benefit patients during and after their procedure."
The next-generation EDWARDS INTUITY Elite valve system combines a unique balloon-expandable frame with Edwards' proven pericardial PERIMOUNT platform, which has demonstrated durability up to 25 years in published studies. The new system has design improvements intended to improve ease of use, including a flexible and lower profile delivery system that is designed to facilitate access and visibility through smaller incisions.
"We've enhanced the EDWARDS INTUITY design to further meet the needs of patients, physicians and hospitals with a valve and procedure that can be readily incorporated into the surgeon's treatment offerings," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "We believe the EDWARDS INTUITY platform can greatly expand the population of patients who receive the less-invasive approach with important clinical and cost benefits."
Advanced Innovation for Surgeons and Patients Backed by Robust Clinical Data
Data from 100 patients in the CADENCE-MIS trial, a randomized, controlled, multi-center trial comparing minimally-invasive AVR with the EDWARDS INTUITY valve system to full sternotomy AVR with any conventional bioprosthetic aortic valve, were recently presented at the 2014 Annual Meeting of the Society of Thoracic Surgeons (STS). The trial found:
- Minimally-invasive AVR with the EDWARDS INTUITY platform demonstrated a statistically significant reduction (24 percent) in ischemic time (the amount of time blood flow to and from the heart is stopped during surgery) compared to the full sternotomy approach with conventional bioprosthetic valves. These results are especially meaningful as minimally-invasive approaches have traditionally been associated with longer ischemic times; and
- Improved blood flow and hemodynamics with the EDWARDS INTUITY valve compared to conventional bioprosthetic valves at 3-month follow-up.
Additionally, an interim analysis of 158 patients undergoing isolated aortic valve replacement in the prospective, multicenter, single-arm TRITON Trial(1) for the EDWARDS INTUITY platform, found that 55 percent were performed through a minimally invasive approach, as opposed to a full sternotomy.
The EDWARDS INTUITY Elite Valve System is currently being studied as part of the TRANSFORM Trial, the first U.S. clinical trial of a rapid deployment system for surgical aortic valve replacement. It is an investigational device and not yet available for sale or use in the United States. The system will be commercially available at hospitals throughout Europe and is supported with favorable reimbursement in Germany as part of diagnosis-related group (DRG) mapping that includes the new category of rapid-deployment aortic valve systems.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.
(1) The TRITON Trial involved six European centers and treated a total of 287 patients with the EDWARDS INTUITY platform between Jan. 2010 and Oct. 2012.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, Dr. Borger and Mr. Bobo's statements and statements regarding the launch and estimated roll-out of the EDWARDS INTUITY Elite Valve System, design features and expected product benefits and procedural outcomes. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause the roll-out and benefits of the technology to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to expanded clinical experience, unexpected changes or delays related to product supply, quality and availability, changes in product indications or reimbursement levels, or regulatory decisions. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2013.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS INTUITY, EDWARDS INTUITY Elite, CADENCE, Carpentier-Edwards, PERIMOUNT and TRANSFORM are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
David K. Erickson
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
Feb. 23, 2017 10:00 PM EST Reads: 4,551
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Feb. 23, 2017 09:15 PM EST Reads: 1,457
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
Feb. 23, 2017 08:45 PM EST Reads: 1,251
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Feb. 23, 2017 08:30 PM EST Reads: 1,404
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
Feb. 23, 2017 08:15 PM EST Reads: 7,971
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...
Feb. 23, 2017 07:45 PM EST Reads: 3,328
FinTech is the sum of financial and technology, and it’s one of the fastest growing tech industries. Total global investments in FinTech almost reached $50 billion last year, but there is still a great deal of confusion over what it is and what it means – especially as it applies to retirement. Building financial startups is not simple, but with the right team, technology and an innovative approach it can be an extremely interesting domain to disrupt. FinTech heralds a financial revolution that...
Feb. 23, 2017 07:30 PM EST Reads: 1,706
SYS-CON Events announced today that IoT Now has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
Feb. 23, 2017 06:45 PM EST Reads: 1,420
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Feb. 23, 2017 06:30 PM EST Reads: 6,258
SYS-CON Events announced today that WineSOFT will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Based in Seoul and Irvine, WineSOFT is an innovative software house focusing on internet infrastructure solutions. The venture started as a bootstrap start-up in 2010 by focusing on making the internet faster and more powerful. WineSOFT’s knowledge is based on the expertise of TCP/IP, VPN, SSL, peer-to-peer, mob...
Feb. 23, 2017 06:30 PM EST Reads: 1,681
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, discussed the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports.
Feb. 23, 2017 06:00 PM EST Reads: 1,465
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Feb. 23, 2017 06:00 PM EST Reads: 12,994
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Feb. 23, 2017 05:45 PM EST Reads: 1,177
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Feb. 23, 2017 05:30 PM EST Reads: 1,933
For organizations that have amassed large sums of software complexity, taking a microservices approach is the first step toward DevOps and continuous improvement / development. Integrating system-level analysis with microservices makes it easier to change and add functionality to applications at any time without the increase of risk. Before you start big transformation projects or a cloud migration, make sure these changes won’t take down your entire organization.
Feb. 23, 2017 05:15 PM EST Reads: 1,123