Yet again, US FDA holds off watchman approval for Boston
This article was originally published in Clinica
Executive Summary
US approval of the Watchman stroke prevention device remains out of reach for its manufacturer, Boston Scientific, after the US FDA asked for another advisory panel meeting – the third since 2009. While Leerink analyst Danielle Antalffy believes premarket approval of the left atrial appendage closure device is not a complete write-off, Boston has said that the decision will delay the launch to, at earliest, the first half of 2015.