Reuters: Regulatory News: US FDA staff concerned on HeartWare device safety

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US FDA staff concerned on HeartWare device safety Apr 23rd 2012, 12:26 WASHINGTON, April 23 | Mon Apr 23, 2012 8:26am EDT 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.

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