FDA Used Real-World Evidence in Heart Valve Approval
By Michael Mezher -
Published 14 June 2017
The US Food and Drug Administration (FDA) says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement (TAVR) to valve-in-valve procedures.
Categories: News, US, CDRH, Medical Devices, Submission and registration
Tags: Sapien 3, Edwards Lifesciences, Real-World Evidence