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.