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HeartWare Receives FDA Approval To Enroll Supplemental Patient Cohort In Destination Therapy Trial

   HeartWare Receives FDA Approval To Enroll Supplemental Patient Cohort In
                          Destination Therapy Trial

- Amended protocol includes enhanced blood pressure monitoring to ensure
optimal patient management -

PR Newswire

FRAMINGHAM, Mass. and SYDNEY, Aug. 27, 2013

FRAMINGHAM, Mass. and SYDNEY, Aug. 27, 2013 /PRNewswire/ --HeartWare
International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less
invasive, miniaturized circulatory support technologies that are
revolutionizing the treatment of advanced heart failure, today announced that
the U.S. Food and Drug Administration (FDA) has approved an IDE
(Investigational Device Exemption) Supplement that allows HeartWare to
commence enrollment in an additional patient cohort for ENDURANCE, the
Company's pivotal, Destination Therapy clinical study.

In this supplemental cohort, HeartWare will enroll up to 286 patients
receiving the HeartWare^® Ventricular Assist System, as well as up to an
additional 143 control patients using a randomization scheme consistent with
the ENDURANCE protocol. Patients will be followed for 12 months after
implant. HeartWare intends to incorporate the data from both this new cohort
and ENDURANCE into an anticipated Pre-Market Approval (PMA) Application
seeking approval of the HeartWare System for the Destination Therapy
indication. 

The protocol for this cohort is designed to confirm clinical observations that
sites adhering to more regular monitoring and management of patient blood
pressure witnessed a notably lower incidence of neurological events.

Patient enrollment can commence at the 50 centers participating in the
ENDURANCE clinical trial, following Institutional Review Board approvals at
each of the centers. 

On November 20, 2012, FDA granted approval of the HeartWare System for the
Bridge-to-Transplant indication. Concurrent with approval, the Company
commenced a post-approval study (PAS) to assess device performance in a
real-world setting. HeartWare's PAS is a registry consisting of 600 patients
who receive an HVAD and an additional 600 control patients derived from a
contemporaneous group of continuous flow, intra-corporeal LVAD patients
entered into the INTERMACS database. HeartWare expects enrollment for both
arms of the PAS will be complete by year's end.

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-support circulatory assist
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, has received CE Marking in the European Union
and has been used to treat patients in 35 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.

HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of
HeartWare, Inc.

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 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 and post-approval studies,
regulatory status, research and development activities and the commercial
launch of the HeartWare^® Ventricular Assist System in the U.S. 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. HeartWare does
not assume any obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise. HeartWare 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 Part I, Item 1A. "Risk Factors" in HeartWare's Annual Report on
Form 10-K filed with the Securities and Exchange Commission. HeartWare may
update risk factors from time to time in Part II, Item 1A "Risk Factors" in
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings
with the Securities and Exchange Commission.

For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864

SOURCE HeartWare International, Inc.

Website: http://www.heartware.com
 
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