HIN heartware international, inc

HeartWare: U.S. FDA authorizes expansion to 40 clinical sites...

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    HeartWare: U.S. FDA authorizes expansion to 40 clinical sites for HeartWare U.S. bridge-to-transplant clinical trial Co announced that it has received approval from the U.S. Food and Drug Administration (FDA) to expand the number of clinical sites participating in its U.S. bridge-to-transplant trial, known as the ADVANCE trial. Pursuant to the FDA approval, HTWR will be permitted to enroll a total of 40 clinical sites for the purposes of evaluating the co's Ventricular Assist System in end-stage heart failure patients requiring circulatory support to bridge them to a heart transplant. Co says, "While we have had strong interest from high caliber transplant centers that want to join our ADVANCE trial, we could not previously accommodate them due to our existing 28 clinical site limitation. Receipt of FDA approval enabling expansion from 28 to 40 clinical sites allows us to accept many of these additional sites prior to the completion of enrolment which we project will occur in the first half of 2010."

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