US FDA staff concerned on HeartWare device safety
WASHINGTON, April 23
WASHINGTON, April 23 (Reuters) - U.S. medical device reviewers said HeartWare International Inc's blood pump seemed to help people with severe heart failure but raised concerns about device-associated clotting rates and stroke.
U.S. Food and Drug Administration staff also said clinical trials for the mechanical heart-assist device, or the HeartWare ventricular assist device (HVAD), may have missing data and are difficult to compare with a registry of patients.
The FDA staff review, which was posted online on Monday, comes ahead of a meeting of outside experts who are due to vote on the device on Wednesday. The FDA will make a final decision later.