FRAMINGHAM, Mass. and SYDNEY, April 24 /PRNewswire-FirstCall/ -- HeartWare
International, Inc. (Nasdaq: HTWR) (ASX: HIN) today announced updated results
for its international clinical trial of the HeartWare(R) Left Ventricular
Assist System. The results were presented by Dr. Martin Strueber,
cardiothoracic surgeon at Hannover Medical School, at the annual meeting of
the International Society for Heart and Lung Transplantation (ISHLT) held in
Paris this week. A full copy of the presentation was filed as part of a form
8-K with the U.S. Securities and Exchange Commission and can be accessed at
The data presented at ISHLT includes all 50 patients enrolled in the trial
across 5 participating centers. The data show a survival rate of 90% at 6
months and a survival rate of approximately 86% at 12 months post implant*. On
average, the patients were supported by the HeartWare(R) System for 300 days
each. The cumulative duration of support across the group exceeded 41 years.
The patients' quality of life showed significant improvement at all points
post-implant and the rates of adverse events were relatively low despite the
unusually long average duration of pump support across the patient group.
"These results appear again to confirm the benefits we believe to be
inherent in the design of this device," said HeartWare CEO, Mr. Doug Godshall.
"At the ISHLT meeting 12 months ago we reported a 90% survival among our
initial patient cohort. It is pleasing to observe that this success rate has
been maintained over a far larger patient group and over a longer period of
time. We anticipate these positive data providing a meaningful stimulus as we
make the system more broadly available in our International markets and as we
accelerate enrolment in our US Bridge to Transplant clinical trial."
* The data includes all patients through February 26, 2009. As of today,
3 patients have yet to pass the endpoint of the international clinical trial
and the last of these is expected to do so in early June.
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable
heart pumps, or Left Ventricular Assist Devices (LVADs), to treat patients
suffering from advanced heart failure. The HeartWare(R) Ventricular Assist
System features the HVAD(TM) pump, the only full-output pump designed to be
implanted next to the heart, avoiding the abdominal surgery generally required
to implant competing devices. HeartWare has completed an international
clinical trial for the device involving five investigational centres in Europe
and Australia. The device is currently the subject of a 150-patient clinical
trial in the United States for a Bridge-to-Transplant indication.
For further information:
www.heartware.com US Investor Relations
Howard Leibman Matt Clawson
Director Corporate Development Partner
HeartWare Limited Allen & Caron Inc
Email. email@example.com Email. firstname.lastname@example.org
Tel. +61 2 9238 2064 Tel. +1 949 474 4300
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, and those described in other
reports filed from time to time with the SEC.
SOURCE HeartWare International, Inc.