Edwards PVT Trial
This article was originally published in The Gray Sheet
Executive Summary
FDA and Irvine, Calif. firm's discussions on resuming the company's PVT percutaneous aortic valve feasibility trial have included modifying patient enrollment goals from the original protocol, CEO Michael Mussallem indicated in a July 21 Q2 earnings call. Edwards still plans to begin enrollment by year-end for the study that will incorporate an updated valve delivery system (1"The Gray Sheet" June 20, 2005, p. 17)...