Sapien 3 TAVR gets approval for low-risk patientsOctober 8, 2019
The US FDA has expanded the use of the Edwards Sapien 3 and Sapien 3 Ultra transcatheter heart valve systems to the treatment of severe, symptomatic aortic stenosis (AS) patients who are determined to be at low risk of open-heart surgery.
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.
“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,” said Larry L Wood, Edwards’ corporate vice president, transcatheter aortic valve replacement.
This low-risk approval covers the Sapien 3 and Sapien 3 Ultra valves in all sizes, Edwards Lifesciences said in a statement.