FDA Panel Torn on Watchman Device

October 9, 2014 6:01 PM

16 0

GAITHERSBURG, Md. -- An FDA advisory committee struggling with limits of the regulatory process delivered a split vote Wednesday along with a nuanced recommendation -- once again leaving the Watchman left atrial appendage closure device's future in serious doubt.

The Circulatory System Devices Advisory Panel convened to deliberate the Watchman device's risk-benefit profile, after updated clinical trial data from the PREVAIL trial showed a higher incidence of ischemic stroke in Watchman subjects who were given short-term warfarin compared to a control group g...

Read more

To category page