Edwards Completes Enrollment In PARTNER 3 Low-Risk CT Sub-Study, Updates Timeline For SAPIEN 3 Ultra System Launch In Europe
IRVINE, Calif., March 21, 2018 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that enrollment is complete in the computed tomography (CT) imaging sub-study within the PARTNER 3 trial of the SAPIEN 3 valve. This randomized sub-study is examining leaflet mobility of both the SAPIEN 3 valve and surgical heart valves in low-risk patients undergoing valve replacement for the treatment of severe aortic stenosis.
Enrollment in the PARTNER 3 main study of the SAPIEN 3 valve in low-risk patients was already complete. As previously indicated, Edwards continues to anticipate that data from the PARTNER 3 trial will be presented at ACC 2019, and expects to receive FDA approval for the indication late that year.
In addition, Edwards is studying the SAPIEN 3 Ultra System as part of a single-arm multi-center trial of up to 30 intermediate-risk patients. These data will be utilized to supplement the European regulatory filing for the SAPIEN 3 Ultra System. Edwards now expects that the European launch of the SAPIEN 3 Ultra system will occur later in 2018. This updated timing for the European launch of the SAPIEN 3 Ultra System does not change the company's sales guidance for 2018, and Edwards continues to expect the U.S. introduction of this system in late 2018.
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.
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, as well as dates of commercial availability and clinical trial result 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 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, 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 SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, PARTNER 3, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
# # #