Will approval of Edwards' Sapien in lower-risk patients be delayed after panel meeting push-back?
This article was originally published in Clinica
Executive Summary
Edwards Lifesciences' Sapien transcatheter heart valve looks unlikely to gain US FDA approval in a new cohort of lower-risk patients in the first half of this year. That is according to JP Morgan, which reported that a panel to discuss the device in the new population has been delayed until June.