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HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
Date:4/25/2012

FRAMINGHAM, Mass. and SYDNEY, April 25, 2012 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN) today announced that NASDAQ has halted trading of the Company's common stock.  The U.S. Food and Drug Administration's (FDA) Circulatory System Devices Advisory Committee meets today to review HeartWare's Premarket Approval (PMA) application for the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.

HeartWare's PMA submission encompasses data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption study designed to evaluate the HVAD System as a bridge to heart transplantation for patients with end-stage heart failure.  Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010.  HeartWare submitted the PMA in December 2010. 

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® pump, a small full-output circulatory support device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.  The HeartWare System has received CE Marking in the European Union and TGA approval in Australia.  The device is currently the subject of United States clinical trials for two indications: destination therapy and bridge-to-transplant under a continued access protocol.  For additional information, please visit the Company's website at www.heartware.com.

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SOURCE HeartWare International, Inc.
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Related medicine technology :

1. Presentation of HeartWare Clinical Results
2. HeartWare International Clinical Trial Shows 90% Survival at 180 Days
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
8. HeartWare to Report Financial Results for Third Quarter of 2010
9. HeartWare International Reports Third Quarter 2010 Revenues of $13.8 Million; Compared to $7.5 Million in Third Quarter of 2009
10. HeartWare Bridge-to-Transplant Data Featured as Late Breaking Clinical Trial at American Heart Association Scientific Sessions 2010
11. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
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