Edwards Lifesciences Wins FDA Approval for Aortic Valve-in-Valve Procedures

The FDA has granted approval to Edwards Lifesciences for aortic valve-in-valve procedures using its Edwards SAPIEN XT transcatheter heart valve.

A 197-patient study found that patients treated with the transcatheter valve had a one-year survival rate of 86.6 percent and a stroke rate of 3.7 percent.

The valve was approved by the FDA in June 2014 for patients at high risk for native aortic valve replacement surgery. It also received CE Mark for valve-in-valve procedures in 2014.

Headquartered in Irvine, Calif., Edwards Lifesciences focuses on the science of heart valves and hemodynamic monitoring. — Michael Cipriano