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U.S. FDA Authorizes Expansion to 40 Clinical Sites for HeartWare U.S. Bridge-to-Transplant Clinical Trial
Date:10/5/2009

FRAMINGHAM, Mass. and SYDNEY, Oct. 5 /PRNewswire-FirstCall/ -- HeartWare International, Inc. (Nasdaq: HTWR, ASX: HIN) today 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, HeartWare will be permitted to enroll a total of 40 clinical sites for the purposes of evaluating the Company's Ventricular Assist System (HVAD) in end-stage heart failure patients requiring circulatory support to bridge them to a heart transplant.

"We continue to be encouraged by the number of physicians who believe the HVAD may provide an important benefit for their patients and we hope that the enthusiasm for our system continues to grow as their experience expands," said Doug Godshall, President and CEO of HeartWare.

"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," continued Godshall.

At present, HeartWare currently has 22 clinical sites initiated in the United Sites with 69 patients implanted in the 150 patient study.

About End Stage Heart Failure

Heart failure is one of the leading causes of death in the developed world. According to the American Heart Association, congestive heart failure (CHF) afflicts approximately 5 million people in the U.S. with approximately 550,000 new cases diagnosed each year. Despite new treatment strategies for patients with end-stage heart failure, the number of patients who die with this disease is of epidemic proportion. Cardia
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SOURCE HeartWare International, Inc.
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