HeartWare International Surpasses 50 Implants in the US

Thu Aug 20, 2009 5:30pm EDT

* Reuters is not responsible for the content in this press release.

FRAMINGHAM, Mass. and SYDNEY, Aug. 20 /PRNewswire-FirstCall/ -- HeartWare
International, Inc. (Nasdaq: HTWR - ASX: HIN) today announced that HeartWare
has surpassed 50 implants in the United States under its ADVANCE Clinical
Trial, marking an important early enrollment milestone. 

The 50th implant in the US was performed last week at the Texas Heart
Institute in Houston, Texas by O.H. Frazier, MD a distinguished surgeon,
scientist, and academician renowned for his research and development of new
cardiovascular surgical techniques and ventricular assist devices.  "We are
very pleased with the early clinical results of this small pump.  Its unique
inflow cannula and small size enable us to place the device without a surgical
pump pocket, which greatly reduces the risk of serious infection.  The
improved pump simplifies implantation and allows for optimal function, even in
difficult cases where the myocardium is thin or the apex of the ventricle is
difficult to access," said Dr. Frazier. 

HeartWare's ADVANCE Clinical Trial is an FDA approved IDE study designed to
evaluate the HeartWare((R))( )Ventricular Assist system as a bridge to heart
transplantation for patients with end-stage heart failure.  The primary
endpoint of the trial is survival at 180-days post surgical implantation. 
Under the IDE, a total of 150 patients will be enrolled across a maximum of 28
centers.  Currently, 16 centers are enrolling patients.  HeartWare expects the
number of active centers to expand steadily over coming months as the balance
of the 28 sites work through the steps required to begin enrolling patients.

About End-Stage Heart Failure
Heart failure is one of the leading causes of death in the developed world.
According to the American Heart Association, congestive heart failure (CHF)
afflicts approximately 5 million people in the US with approximately 550,000
new cases diagnosed each year. Despite new treatment strategies for patients
with end-stage heart failure, the number of patients who die with this disease
is of epidemic proportion. Cardiac transplantation is currently the most
effective therapy for the treatment of advanced end-stage heart failure,
however, its application is limited due to the lack of available donor organs.

Over the last decade, bridging to cardiac transplantation with implantable
left ventricular assist devices (LVADs) has gained wider clinical acceptance
and LVADs are used to extend life expectancy for patients with end-stage heart
failure who might otherwise deteriorate while awaiting a donor heart.

About HeartWare International
HeartWare International develops and manufactures miniaturized implantable
heart pumps, or left ventricular assist devices, to treat Class IIIb and Class
IV patients suffering from advanced heart failure. The HeartWare((R))
Ventricular Assist System features the HVAD((TM)) 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((R))
Ventricular Assist System in the European Union.  The device is currently the
subject of a 150-patient clinical trial in the United States for a
Bridge-to-Transplant indication. 

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

    For further information:
    www.heartware.com                           US Investor Relations
    Howard Leibman                              Matt Clawson
    HeartWare International                     Allen & Caron, Inc
    Email. howard.leibman@heartware.com.au      Email. matt@allencaron.com
    Tel.  +61 402 440 644                       Tel. +1 949 474 4300

Forward-Looking Statements 

This announcement contains forward-looking statements that are based on
management's beliefs, assumptions and expectations and on information
currently available to management. All statements that address operating
performance, events or developments that we expect or anticipate will occur in
the future are forward-looking statements, including without limitation our
expectations with respect to the progress of clinical trials. Management
believes that these forward-looking statements are reasonable as and when
made. However, you should not place undue reliance on forward-looking
statements because they speak only as of the date when made. We do not assume
any obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise. We may not
actually achieve the plans, projections or expectations disclosed in
forward-looking statements, and actual results, developments or events could
differ materially from those disclosed in the forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties,
including without limitation those described in "Item 1A. Risk Factors" in our
Annual Report on Form 10-K filed with the SEC on February 28, 2008, and those
described in other reports filed from time to time with the SEC.

SOURCE  HeartWare International, Inc.

Howard Leibman of HeartWare International, Inc., +61 402 440 644,
howard.leibman@heartware.com.au; or US Investor Relations, Matt Clawson of
Allen & Caron, Inc, +1-949-474-4300, matt@allencaron.com, for HeartWare
International, Inc.
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