Edwards Announces Key Events For PCR London Valves 2017

Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced key events for the company during the PCR London Valves 2017 course, as the meeting celebrates 15 years of transcatheter aortic valve replacement.

Among the scheduled events and data presentations are:

• Introduction of the Edwards SAPIEN 3 Ultra System – Edwards’ CE Mark-pending system for transcatheter aortic valve replacement includes the new SAPIEN 3 Ultra valve, which adds a taller outer skirt to the proven SAPIEN 3 valve design. Initially incorporated with valve sizes 20, 23 and 26 mm, this new feature is designed to further improve the SAPIEN 3 valve’s best-in-class outcomes. The valve is offered with the SAPIEN 3 Ultra delivery system, which introduces an “on balloon” design, removing the need for valve alignment during the procedure, and is compatible with the new 14F Axela expandable sheath. The Edwards SAPIEN 3 Ultra System is expected to receive CE Mark by the end of the year, and the company also has plans to introduce this system in the United States late in 2018.
• 6-month outcomes with the Edwards CENTERA Transcatheter Heart Valve System – On Monday, Sept. 25, in the Late-Breaking TAVI Trials session, new results of the self-expanding Edwards CENTERA valve will be discussed. Results presented earlier this year on the 30-day outcomes with the CENTERA valve demonstrated a very high survival rate, a low disabling stroke rate and a low percent permanent pacemaker rate. In addition, there was a low rate of moderate paravalvular leak among patients, and no severe paravalvular leak reported at 30 days after transcatheter valve replacement. 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.
• Symposium: Transcatheter heart valve therapies for all heart valves: from an innovation strategy to mainstream therapy – This sponsored session on Sunday, Sept. 24, is intended to review the latest clinical trials involving Edwards’ aortic, mitral, tricuspid and pulmonary valve therapies.
• Symposium: Edwards Cardioband Transcatheter Valve Repair System: expanding options for patients – This sponsored session on Tuesday, Sept. 26, is focused on the current experience and clinical results of the Edwards Cardioband system and a discussion of Edwards’ innovations for transcatheter valve therapies.

“As PCR London Valves celebrates 15 years of transcatheter aortic valve replacement, Edwards is proud to have led the development and evolution of TAVR as a preferred therapy for patients in need around the world,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves.

The Edwards SAPIEN 3 Ultra System and CENTERA Transcatheter Heart Valve System are not currently available for commercial sale in any country.

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 approvals, dates of commercial availability and expected 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, Axela, Cardioband, CENTERA, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.