|By Marketwired .||
|April 30, 2014 09:15 AM EDT||
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.
David K. Erickson