Comunicati stampa

PARIS, May 21, 2018 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced key events for the company during EuroPCR 2018, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC). The event takes place May 22 to 25 at the Palais des Congrès in Paris.

Among the scheduled data presentations are three late-breaking clinical trials:

• CENTERA-EU: One-year outcomes assessing a novel self-expanding transcatheter heart valve – On May 22, new one-year results of the self-expanding Edwards CENTERA valve will be discussed. Results presented last year on the 30-day outcomes with the 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. The Edwards CENTERA valve received CE Mark in February.
• Comparison of data from the TVT registry with PARTNER2 S3 studies: Real-world outcomes of TAVR with balloon-expandable valve in intermediate-risk patients – Also on May 22, 30-day real-world outcomes data from treatment with the SAPIEN 3 valve will be presented and compared with controlled clinical trials in a propensity-matched analysis for severe, symptomatic aortic stenosis patients at intermediate-risk of open-heart surgery. A total of 1,956 intermediate-risk patients in the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry were compared with 652 intermediate-risk patients enrolled in the PARTNER II S3i study and 652 patients enrolled in the S3 intermediate-risk continued access program (S3iCAP) at 30 days.
• SAPIEN 3 outcomes for bicuspid vs tricuspid aortic valve stenosis: Propensity matched results – On May 23, there will be a discussion of one-year TAVR outcomes for patients with native bicuspid aortic valves as compared to those with tricuspid aortic valves, both of which were treated with the SAPIEN 3 valve. The data is excerpted from the real-world STS/ACC TVT Registry.

Additional sessions of interest include:

• Transcatheter mitral valve repair in patients with functional mitral regurgitation: Up to two-year outcomes from the multicentre CE trial – On May 24, two-year outcomes from the multi-center CE Mark trial evaluating the Edwards Cardioband Transcatheter Mitral Valve Reconstruction System in patients with functional mitral regurgitation will be discussed.
• Transcatheter tricuspid valve repair: Up to six-month results from the multicentre trial – On May 25, six-month outcomes from the multi-center TRI-REPAIR study evaluating the Edwards Cardioband Tricuspid Valve Reconstruction System in patients with functional tricuspid regurgitation will be discussed. The Cardioband Tricuspid System is the first commercially available transcatheter therapy for the treatment of tricuspid heart valve disease, and received CE Mark in April.

The Edwards CENTERA valve and Edwards Cardioband Tricuspid and Mitral Systems are not available for commercial sale in the U.S.

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 regarding expected future product presentations. 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 products or unanticipated delays. 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, Cardioband, CENTERA, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

 

# # #