Welcome!

News Feed Item

EDWARDS INTUITY Valve Data Demonstrate Improved Patient Benefits Over Standard Surgical Valves

TORONTO, ON -- (Marketwired) -- 04/30/14 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that three-year clinical outcomes of its EDWARDS INTUITY valve platform demonstrated improved cardiac and valvular performance, as well as patient functional status.

These new data from the TRITON(1) Trial were presented at the American Association for Thoracic Surgery's (AATS) 94th Annual Meeting in Toronto, Canada, by Thorsten Wahlers, M.D., Ph.D., Hospital and Health Center for Heart and Thoracic Surgery, University Clinic, Cologne, Germany.

The interim analysis of 287 patients who underwent aortic valve replacement with the EDWARDS INTUITY platform included 138 that received the next-generation EDWARDS INTUITY Elite rapid-deployment valve. The EDWARDS INTUITY valve platform combines the proven Carpentier-Edwards PERIMOUNT design with a balloon-expandable, cloth-covered frame, which enables the use of fewer sutures during valve replacement surgery.

"There is evidence from our experience that the expansion of the frame during valve implantation can potentially widen and reshape a narrowed left ventricular outflow tract, which directs blood flow into the aortic valve. This patient benefit was demonstrated in our study through clinically significant reductions in aortic valve mean pressure gradient and left ventricular size," said Dr. Wahlers. "This design element also helped clinicians better select a valve size most appropriate for the patient, which can be a challenge with conventional valves, and enabled more efficient blood flow through the valve."

At three years, the study reported that rapid deployment aortic valve replacement using the EDWARDS INTUITY valve platform in patients with aortic stenosis was associated with beneficial outcomes including:

  • Statistically significantly hemodynamic performance improvement of the bioprosthetic valve, as indicated by a low aortic valve (AV) pressure gradient (mean 8.7 mmHg overall); and
  • Improved heart function, as demonstrated by a statistically significant reduction in left ventricular size over time (16 percent reduction in mean LV mass index).

"We are pleased that these data demonstrated important advantages that were meaningful for patients, which is significant given that the EDWARDS INTUITY valve platform is built on the proven Carpentier-Edwards PERIMOUNT heart valve design and represents a new procedural approach to aortic valve surgery. We are continuing our launch of the EDWARDS INTUITY Elite valve in Europe, to provide a new treatment option for surgeons that is built on a surgical valve platform they trust," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy.

The EDWARDS INTUITY Elite valve platform is currently being studied as part of the TRANSFORM Trial, the first U.S. clinical trial of a rapid deployment aortic valve replacement. It is an investigational device and not yet available for sale or use in the United States.

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. Wahler's and Mr. Bobo's statements and statements regarding design features and expected product benefits and procedural outcomes from the EDWARDS INTUITY Elite Valve System. 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 unexpected outcomes after expanded and extended 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, Carpentier-Edwards, PERIMOUNT and TRANSFORM are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Media Contact:
Steve Chesterman
949-250-5070

Investor Contact:
David K. Erickson
949-250-6826

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
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...
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
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, will discuss 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. The session will include a working demo and a technical d...
SYS-CON Events announced today that China Unicom 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. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE F...
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
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.
Digital innovation is the next big wave of business transformation based on digital technologies of which IoT and Big Data are key components, For example: Business boundary innovation is a challenge to excavate third-party business value using IoT and BigData, like Nest Business structure innovation may propose re-building business structure from scratch, as Uber does in the taxicab industry The social model innovation is also a big challenge to the new social architecture with the design fr...
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
In his session at @DevOpsSummit at 19th Cloud Expo, Robert Doyle, lead architect at eCube Systems, will examine the issues and need for an agile infrastructure and show the advantages of capturing developer knowledge in an exportable file for migration into production. He will introduce the use of NXTmonitor, a next-generation DevOps tool that captures application environments, dependencies and start/stop procedures in a portable configuration file with an easy-to-use GUI. In addition to captu...