Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark
IRVINE, Calif., Feb. 15, 2018 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards CENTERA valve is repositionable and retrievable and 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.
"With the Edwards CENTERA valve, European clinicians and their patients may now benefit from a self-expanding TAVR option that has demonstrated exceptional clinical safety and performance outcomes in the high surgical risk population," said Didier Tchétché, M.D., of Clinique Pasteur in Toulouse, France. "Enhanced design features of the CENTERA valve, including a motorized handle that enables stable valve deployment, allow for a simpler procedure with compelling outcomes."
European certification of the CENTERA valve was based on the CENTERA-EU Trial, which enrolled 203 high-risk patients at 23 centers in Europe, Australia and New Zealand. Study results presented at EuroPCR 2017 demonstrated high survival rates (99 percent) and low rates of disabling stroke (2.5 percent) and new permanent pacemaker (4.9 percent) at 30 days. In addition, there was a low 0.6 percent rate of moderate paravalvular leak among patients, and zero incidents of severe paravalvular leak. All patients in the study were treated via the transfemoral access route with the majority under conscious sedation.
"Edwards is committed to partnering with clinicians to offer differentiated, best-in-class technologies for transcatheter heart valve therapy," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "European certification of the CENTERA valve provides a meaningful treatment option for high-risk TAVR patients when their heart team recommends a self-expanding device."
The CENTERA valve is not approved for commercial sale in the U.S.
Dr. Tchétché is a consultant to Edwards Lifesciences.
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 @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, statements by Mr. Wood and Dr. Tchétché and statements regarding future benefits and expected outcomes with the valve. 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 longer-term clinical experience, or unexpected changes or delays related to regulatory clearance, reimbursement, product manufacturing or clinical practice. 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, 2016. Our filings, along with important product safety information, are available at www.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.
# # #