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HeartWare Completes Enrollment In 450-Patient Pivotal Destination Therapy Clinical Trial
Date:5/8/2012

eriod extending to five years post implant. 

The primary endpoint of the trial is survival at two years, defined as alive on the originally implanted device without a debilitating stroke, transplanted or explanted due to patient recovery.  Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life.  The Company plans to request from the FDA approval to implant additional Destination Therapy patients under a Continued Access Protocol (CAP) in U.S. centers that implanted a patient in the ENDURANCE trial. 

The HeartWare Ventricular Assist System is also under FDA review for a Bridge-to-Transplant indication.  On April 25, 2012, the FDA's Circulatory System Devices Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.  The Advisory Committee's recommendation, while not binding, will be considered by the FDA in its review of the Premarket Approval (PMA) application submitted for the HeartWare Ventricular Assist System 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 (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.  HeartWare has received CE Marking for the HeartWare System in the European Union.  The device is currently the subject of United States clinical trials for two indications: Bridge-to-Transplant u
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SOURCE HeartWare International, Inc.
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4. HeartWare Receives 54-Patient Allotment From FDA Under Continued Access Protocol for Pivotal U.S. Bridge-to-Transplant Clinical Trial
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