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HeartWare Reports Additional Data from Bridge-to-Transplant Clinical Trial and Continued Access Patients
Date:4/15/2011

FRAMINGHAM, Mass. and SYDNEY, April 15, 2011 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced the presentation of updated data from its pivotal bridge to heart transplantation (BTT) study, ADVANCE, showing 180-day survival, using Kaplan-Meier analysis, for a combined 250 investigational device patients in the original study and the continued access cohort patients was 94 percent.

Results presented today at The International Society of Heart and Lung Transplantation (ISHLT) 31st Annual Meeting and Scientific Sessions in San Diego aggregated data from the 140 patients in HeartWare's ADVANCE clinical trial and an additional 110 patients from Continued Access Protocol (CAP) allotments granted by the Food and Drug Administration (FDA) in the past year.  The ADVANCE clinical trial is an FDA approved Investigational Device Exemption (IDE) study designed to evaluate the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.

"Data generated from the CAP patient population confirmed that implantation of the investigational device was associated with a consistently high probability of survival at 180 days, just as we have observed in the ADVANCE study," said Mark Slaughter, M.D., the co-principal investigator for ADVANCE, and Professor and Chief in the Division of Thoracic and Cardiovascular Surgery and Director of the Mechanical Assist Device and Heart Transplant Program at the University of Louisville.  "The adverse event profile from the CAP data was consistent with the very positive rates demonstrated in the ADVANCE trial, with particularly low observed rates of bleeding and infection."

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SOURCE HeartWare International, Inc.
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