IRVINE, Calif., Oct. 8, 2018 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has commenced the U.S. pivotal trial that will study its self-expanding CENTERA transcatheter valve for severe, symptomatic aortic stenosis (AS) patients at intermediate risk of open-heart surgery.
The prospective, single-arm, multi-center study is expected to enroll approximately 1,000 patients and includes a bicuspid registry. The study has a composite endpoint of all-cause death and/or all stroke at 1 year.
"We are pleased to launch this rigorous study, which we believe will build a robust body of evidence to support the use of this feature-rich, self-expanding valve system in the treatment of patients with aortic stenosis," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "We look forward to demonstrating the safety and effectiveness of this advanced transcatheter system."
Separately, Edwards confirmed it has updated its regulatory filings and is now resuming the commercial introduction of the CENTERA valve in Europe after completing the previously announced minor modification to CENTERA's delivery system.
The CENTERA valve was approved in Europe in February 2018 for the treatment of high-risk patients suffering from severe, symptomatic AS. The CENTERA valve is not approved for commercial sale in the U.S.
The Edwards CENTERA valve can be delivered through a low-profile, 14-French, motorized delivery system. It is uniquely packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device preparation.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter at @EdwardsLifesci.
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, Mr. Wood's statements and statements regarding expected timing, scope and outcomes of the clinical trial. 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 results 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 delays or changes in the clinical trial, unanticipated outcomes of the trial or longer term clinical experience with the product, or unanticipated quality or regulatory delays or issues. 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, 2017. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards CENTERA and CENTERA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
SOURCE Edwards Lifesciences Corporation