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HeartWare Receives 54-Patient Allotment From FDA Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial

HeartWare International, Inc. (Nasdaq: HTWR) today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a fourth allotment, of 54 additional patients, in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP). In three prior CAP allotments granted by FDA, 202 patients were enrolled between April 2010 and December 2011.

Posted-In: News FDA

 

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