HeartWare Announces Publication Of Results From U.S. Bridge-To-Transplant Clinical Trial

FRAMINGHAM, Mass. and SYDNEY, May 23, 2012 /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 publication of results from ADVANCE, the Company's U.S. clinical trial evaluating the use of the HeartWare® Ventricular Assist System as a bridge to heart transplantation in patients with advanced heart failure.  The detailed findings from this study are published in the American Heart Association's journal Circulation, and demonstrate the potential utility of the HVAD® Pump to improve treatment outcomes for end-stage heart failure patients.  The paper appears online as an "Ahead of Print" article of Circulation dated May 22, 2012.(1)

"With the publication of the ADVANCE trial in Circulation, cardiologists and cardiac surgeons treating advanced heart failure will now have the opportunity to thoroughly review the excellent results our investigators obtained using the HVAD® Pump to bridge their patients to transplant," noted co-principal investigator Keith Aaronson, M.D. M.S., Professor in the Division of Cardiovascular Medicine and Medical Director of the Heart Transplant Program and Center for Circulatory Support at the University of Michigan, on behalf of the ADVANCE investigators, including Mark Slaughter, M.D., 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 publication describes results from the ADVANCE study of 140 patients from 30 U.S. hospitals who received the HeartWare investigational device. The authors noted high rates of 180-day success and survival and improvements in quality of life and functional capacity for patients with end-stage heart failure that were similar to those seen with cardiac transplantation.  Success was achieved for the primary endpoint by establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001].  Success on the primary endpoint occurred in 92.0% of the investigational device patients in the per protocol study population, 90.7% of the investigational device patients in the safety study population and 90.1% of INTERMACS control patients.  The most common adverse events were typical of those previously reported for an axial design, continuous-flow pump, and included bleeding, infections, stroke and perioperative right heart failure.

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