The SAPIEN 3 TAVR's low-risk approval was based on data from the landmark PARTNER 3 Trial, an independently evaluated, randomized clinical trial comparing outcomes between TAVR and open-heart surgery. TAVR with the SAPIEN 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and rehospitalization at one year. The data were presented in March at the American College of Cardiology's 68th Annual Scientific Session and simultaneously published in the New England Journal of Medicine.
Severe AS is a debilitating disease that often goes undiagnosed and is undertreated, said Larry L. Wood, Edwards' corporate vice president, transcatheter aortic valve replacement. This approval is a significant milestone and will allow all patients diagnosed with severe AS to be considered for TAVR based on their individual preferences and anatomical considerations versus traditional risk scoring.
The SAPIEN family of transcatheter heart valves have treated hundreds of thousands of patients worldwide since 2007, when the SAPIEN valve was first commercially approved in Europe. The SAPIEN 3 TAVR system builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. This low-risk approval covers the SAPIEN 3 and SAPIEN 3 Ultra valves in all sizes.