March 27, 2018 — Edwards Lifesciences Corp. 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 the American College of Cardiology (ACC) 2019 annual meeting, and expects to receive U.S. Food and Drug Administration (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 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.
For more information: www.edwards.com