With FDA Questions Answered, Edwards Expects Sapien Approval “Any Day”
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences expects FDA approval of its Sapien transcatheter aortic heart valve replacement “any day,” CEO Michael Mussallem said Oct. 19.
You may also be interested in...
Sapien Stroke Discussion Continues With Expanded PARTNER Analysis
Investigators from Edwards Lifesciences’ PARTNER clinical trial reported a more detailed analysis of the incidence of stroke in study patients treated with the firm's Sapien transcatheter valve, though there did not appear to be any major new revelations that would impact approvability.
FDA Holds Up Edwards-DexCom Continuous Glucose Monitor For Hospital Use
Edwards Lifesciences' and DexComs’ first-of-its-kind continuous glucose monitor for hospital use is running into delays at FDA.