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HeartWare Receives Conditional Approval of IDE
Date:5/5/2008

FRAMINGHAM, Mass. and SYDNEY, Australia, May 5 /PRNewswire/ -- HeartWare Limited (ASX: HTW) today announced that it had received conditional approval from the United States Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) for its lead product, the HeartWare(R) Left Ventricular Assist System (LVAS).

The granting of conditional IDE approval by the FDA enables the Company to immediately commence its U.S. clinical trial for the HeartWare(R) LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure. HeartWare's Bridge-to-Transplant (BTT) clinical trial protocol incorporates a number of novel elements, the key aspects of which are as follows:

-- The primary endpoint is survival at 180 days. This survival endpoint is

specifically defined to include patients who have received a heart

transplant, patients who remain alive and supported by the device at

180 days, and "recovery" patients who have survived for a minimum of 60

days following the explant of their device. Patients are not required

to be listed for transplant at 180 days in order to be considered a

"success" under the study.

-- The study is a "pivotal trial" and therefore does not include a

feasibility or pilot phase.

-- The study includes a contemporaneous control group. Patient outcomes

will be compared to those of a matched cohort of patients recorded in

the InterAgency Registry for Mechanical Assisted Circulatory Support

(INTERMACS). INTERMACS is a U.S. national registry of patients

implanted with an FDA approved circulatory support device.

-- The trial requires the enrolment of up to 150 patients across a maximum

of 28 centers.

-- HeartWare is permitted to open up to 10 centers immediately. Once 10

patients have been enrolled and supported with the HeartWare(R) LVAS

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SOURCE HeartWare Limited
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