Medtronic’s CoreValve Makes Strides In Japan And U.S.
This article was originally published in The Gray Sheet
Executive Summary
The Japanese regulatory authority has approved Medtronic’s CoreValve transcatheter aortic valve based on data from the CoreValve Japan trial and U.S. trial data. Meanwhile, FDA granted CoreValve its first TAVR approval for a "valve-in-valve" indication for patients with prior replacements.