The heart valve systems are used to treat severe, symptomatic aortic stenosis (AS) patients who are determined to be at low risk of open-heart surgery.
Speaking after the approval, Director of the Centre of Interventional Vascular Therepacy at New York-Presbyterian/Columbia University Medical Centre, Martin Leon, said the “FDA approval of SAPIEN 3 TAVR will expand access across this proven therapy, which should be considered the preferred treatment for the majority of low-risk severe AS Patients.”
The SAPIEN 3 TAVR’s low-risk approval was base on data from the landmark PARTNER 3 Trial, an independently evaluated, randomised clinical trial comparing outcomes between TAVR and open-heart surgery. TAVR with the APIEN 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.
Edward’s corporate vice president for transcatheter aortic valve replacement, Larry Wood, said severe AS was a debilitating disease that often goes undiagnosed and undertreated.
“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,” Mr Wood said.
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.