FDA Expands TAVR to Aortic Stenosis Patients at Low Surgery Risk

The US Food and Drug Administration (FDA) has approved the expanded use of Edwards SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems to include the treatment of severe, symptomatic aortic stenosis (AS) patients at low risk of open-heart surgery.

The low-risk TAVR device approval was based on the data from the landmark PARTNER 3 trial—a randomized, clinical study assessing outcomes between TAVR and open-heart surgery.

Larry L. Wood, Edwards corporate vice president of Transcatheter Aortic Valve Replacement, noted the significance of treated a debilitating, and frequently underdiagnosed disease such as severe aortic stenosis.

“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,” Wood said in a statement.