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HeartWare Receives FDA Approval For HeartWare® Ventricular Assist System As A Bridge To Heart Transplantation For Patients With Advanced Heart Failure

In other clinical development for the HeartWare Ventricular Assist System, HeartWare has completed enrollment of a 450-patient destination therapy study at 50 U.S. sites.  The final patients were implanted in May 2012, with a two-year, primary endpoint follow-up period.  HeartWare has requested a Continued Access Protocol allocation for destination therapy from the FDA. 

Conference CallHeartWare will host a conference call today at 3:00 p.m. U.S. Eastern Time to discuss approval of the HeartWare ® Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.  The call may be accessed by dialing 1-855-235-2089 five minutes prior to the scheduled start time and referencing "HeartWare."  For callers outside the U.S., please dial +1-778-327-3988.

A live webcast of the call will also be available at the Company's website ( www.heartware.com) by selecting "HeartWare FDA Approval Conference Call" under the section titled "Corporate Presentations" on the Home Page.  A replay of the conference call will be available through the above weblink immediately following completion of the call.

About HeartWare InternationalHeartWare 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 is approved in the United States for the intended use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, and has received CE Marking in the European Union and has been used to treat patients in 27 international countries.  The device is also currently the subject of a U.S. clinical trial for destination therapy.  For additional information, please visit the Company's website at www.heartware.com.

HeartWare International, Inc. is a member of the Russell 2000 ® and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.



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