SAN FRANCISCO, CA--(Marketwire -05/02/12)- Edwards Lifesciences Corporation (EW - News), the global leader in the science of heart valves and hemodynamic monitoring, announced that new data from the European multi-center TRITON trial studying the EDWARDS INTUITY valve system highlights the promise of several important benefits, including the facilitation of small-incision surgery for aortic valve replacement (AVR), a high procedural success rate, and consistent and sustained hemodynamic valve performance at one year. The data were presented today during the Emerging Technologies and Techniques Forum at the American Association for Thoracic Surgery's 92nd Annual Meeting in San Francisco.
The EDWARDS INTUITY valve system leverages a proven valve platform and features an innovative balloon-expandable frame for rapid deployment. Rapid deployment AVR may benefit patients by enabling small-incision surgical approaches and reduced operative times, leading to potentially reduced morbidity and faster recovery.
In the prospective, single-arm TRITON trial, six European centers treated 152 consecutive patients in need of surgical AVR; the rate of procedural success for patients receiving the EDWARDS INTUITY valve was 97.3 percent. Surgeons performed 86 isolated AVR procedures, with about half of these cases using small-incision approaches. The EDWARDS INTUITY valve system also showed single-digit mean gradients at one year in all valve sizes, and a low incidence of paravalvular leaks -- a small pressure gradient across the aortic valve is normal and indicative of good hemodynamic performance. Valve-related mortality rates were low; the survival in this group of patients was 98.6 percent at 30 days and, at one year, the Kaplan-Meier curve demonstrated 94 percent freedom from death.
The data also demonstrated shortened procedures, as characterized by reductions in cross-clamp times and the time patients spent on cardiopulmonary bypass. For isolated AVR cases, mean aortic cross-clamp times were reduced by 48 percent, and mean bypass times by 39 percent, compared to times noted in the Society of Thoracic Surgeons' (STS) Adult Cardiac Database. Several published studies indicate that a shorter duration of aortic cross-clamping is associated with a reduction in mortality and morbidity after AVR.
"In addition to establishing low rates of mortality and morbidity and a reproducible valve replacement procedure with the EDWARDS INTUITY valve system, the study gives us confidence in the opportunity to use this system with less-invasive surgical approaches. We also see promise in the performance of the EDWARDS INTUITY valve system due to the early, excellent hemodynamic results and the design inspired by the proven platform of Edwards' family of surgical valves," said Günther Laufer, M.D., chair and professor, cardiac surgery, Medical University of Vienna.
Edwards also announced at AATS that it received CE Mark in Europe for a valve with the GLX next-generation tissue technology, which is designed to enhance anti-calcification, enable a smaller valve profile and improve ease of use.
The EDWARDS INTUITY valve system received CE Mark in Europe in February 2012. It and GLX are investigational and not currently 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 that enable them to save and enhance lives. Additional company information can be found at www.edwards.com.
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, Prof. Laufer's statements and statements regarding potential clinical results and benefits of the EDWARDS INTUITY valve system and of GLX, and potential benefits of rapid deployment aortic valve replacement and of reduced duration of aortic cross-clamping. 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 actual results or experience 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 clinical outcomes following expanded clinical experience and unexpected market developments. These and other 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, 2011.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS INTUITY and GLX are trademarks of Edwards Lifesciences Corporation.
Sarah Huoh or Janet Kim
David K. Erickson