FDA Used Real-World Evidence In Heart Valve Approval

Jun 14, 2017, 16:07 by Michael Croft

RAPS | The US Food and Drug Administration says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement to valve-in-valve procedures.

June 14, 2017 | The US Food and Drug Administration says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement to valve-in-valve procedures. RAPS