FDAnews
www.fdanews.com/articles/145822-fda-heartware-heart-device-appears-to-meet-study-goal

FDA: HeartWare Heart Device Appears to Meet Study Goal

April 23, 2012
The U.S. Food and Drug Administration said Monday that an experimental heart-pump device being developed by HeartWare International appears to have met its study goal, but the agency said it was concerned about strokes.
The Wall Street Journal