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Laschinger, John C., MD; Ibrahim, Nicole G., PhD; Zuckerman, Bram D., MD
Journal of the American College of Cardiology, 07/2015, Letnik: 66, Številka: 3Journal Article
FDA approval to initiate a clinical study of an investigational device also depends on meeting the requirements for nonclinical testing that are relevant to the anatomically and hemodynamically challenging mitral environment. ...it is extremely important that sponsors understand the FDA's nonclinical testing expectations as early as possible to make efficient use of time and resources. ...the consensus report represents an important step in a dynamic process, and the Agency looks forward to continued involvement with MVARC as the technology and clinical application of transcatheter mitral replacement and repair devices evolve.
