PARIS, May 17, 2017 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced late-breaking data at EuroPCR 2017 demonstrating excellent clinical outcomes for transcatheter aortic valve replacement (TAVR) patients treated with the Edwards CENTERA valve. These new 30-day results are the first data presented on the self-expanding Edwards CENTERA valve.
For severe, symptomatic aortic stenosis patients at high risk of open-heart surgery, the Edwards CENTERA valve demonstrated a very high survival rate of 99 percent, a low 2.5 percent disabling stroke rate and a 4.9 percent permanent pacemaker rate the lowest rate ever reported in a multi-center trial for a self-expanding valve. Additionally, there was a low 0.6 percent rate of moderate paravalvular leak among patients, and no severe paravalvular leak. All 203 patients in the study were treated via the transfemoral access route with the majority (174 patients) under conscious sedation.
The Edwards CENTERA valve is repositionable and retrievable and can be delivered through a low-profile 14-French delivery system that features a motorized handle that results in stable valve deployment. The valve is uniquely packaged fully pre-attached which facilitates simple and rapid device preparation.
“The Edwards CENTERA valve demonstrates extremely favorable early clinical safety and performance outcomes in the high surgical risk TAVR population,” said Didier Tchétché, M.D., of Clinique Pasteur in Toulouse, France, who presented the data. “In addition to excellent patient outcomes, the valve also offers several unique features and an innovative tissue design, all of which simplify the procedure for clinicians.”
CENTERA-EU Trial patients were enrolled in 23 centers in Europe, Australia and New Zealand and will be followed for five years. The Edwards CENTERA valve is an investigational device not yet available commercially in any country. Edwards anticipates it will receive CE Mark approval for the CENTERA valve during the fourth quarter.
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, Dr. Tchétché’s statements and statements regarding expected future product benefits and results. 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 outcomes after longer term clinical experience with the product; or unanticipated quality, manufacturing 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, 2016. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, and CENTERA are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
Source: BioSpace
