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HeartWare International Receives Approval From the Therapeutic Goods Administration (TGA) in Australia
Date:3/24/2011

SYDNEY and FRAMINGHAM, Mass., March 24, 2011 /PRNewswire/ -- HeartWare International, Inc. (ASX: HIN; Nasdaq: HTWR), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the Therapeutic Goods Administration (TGA) in Australia, has approved the HeartWare® Ventricular Assist System for listing on the Australian Register of Therapeutic Goods (ARTG).

(Photo:  http://photos.prnewswire.com/prnh/20101114/LA01075)

"As we seek to expand the global commercial markets for our miniaturized circulatory support device, this milestone has special meaning for HeartWare," explained Doug Godshall, President and Chief Executive Officer.  "Royal Perth Hospital and St. Vincent's Hospital in Australia are two of our five initial clinical sites, we first listed HeartWare shares on the Australian Securities Exchange, and the clinical and financial communities within Australia have strongly supported our growth for many years."

Today, more than 900 advanced heart failure patients globally have received the HVAD® pump.  HeartWare received CE Marking in 2009 in the European Union, and in late December 2010, filed a Pre-Market Approval (PMA) application in the United States with the Food and Drug Administration.  In 2010, HeartWare generated revenues of $55 million, two-thirds of which were derived from international markets, compared with $24 million in 2009 revenues.

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure.  The HeartWare® Ventricular Assist System features the HVAD&#
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SOURCE HeartWare International, Inc.
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3. U.S. FDA Authorizes Expansion to 40 Clinical Sites for HeartWare U.S. Bridge-to-Transplant Clinical Trial
4. HeartWare International Reports Third Quarter Revenues of $7.5 Million
5. HeartWare to Present at 21st Annual Piper Jaffray Health Care Conference in New York City
6. HeartWare to Present at the UBS 2010 Global Life Sciences Conference
7. HeartWare to Present at Lazard Capital Markets Circulatory Assist Device Day
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