Edwards Lifesciences has completed enrollment 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.
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.
Source: Company Press Release