FRAMINGHAM, Mass., April 27, 2016 /PRNewswire/ -- HeartWare
International, Inc. (NASDAQ: HTWR), a leading innovator of
less-invasive, miniaturized circulatory support technologies that
are revolutionizing the treatment of advanced heart failure, today
announced completion of enrollment in the HeartWare®
Ventricular Assist System (HVAD® System) LATERAL
Study™.
LATERAL is a U.S. Investigational Device Exemption (IDE)
prospective clinical trial designed to study the clinical outcomes
of patients with end-stage heart failure who are awaiting a heart
transplant, and are implanted with the HVAD® Pump
through a less-invasive thoracotomy procedure.
Currently, commercially available ventricular assist devices
(VADs) are approved by the U.S. Food and Drug Administration (FDA)
for use with implantation via median sternotomy– a common approach
in cardiac surgery that utilizes a vertical incision through the
center of the patient's chest. The HVAD System features the
HVAD Pump, which is smaller than other commercially available
devices, which more easily enables implantation through a small,
lateral thoracotomy incision between the patient's ribs on the left
side of the chest.
"We are pleased to have completed enrollment in this important
study, which has the potential to allow for easier, less-invasive
implantation while leading to faster patient recovery than the
traditional median sternotomy approach," said Ed McGee, M.D., head of the heart transplant and
assist device program and a professor in the Department of Thoracic
and Cardiovascular Surgery at Loyola
University Stritch School of Medicine in Illinois, and a co-principal investigator for
the HVAD LATERAL Study. "This less invasive surgical
technique also benefits patients by delaying the need for full
sternotomy until cardiac transplantation, enabling an easier
surgical procedure at the time of transplant. We look forward
to monitoring patients through the six-month follow-up period and
then reviewing the trial results to help inform the medical
community about the potential benefits of the thoracotomy
implantation technique."
The first clinical trial of a full-support VAD using an implant
technique other than sternotomy, the HVAD LATERAL Study is a
prospective, multicenter, single-arm clinical trial that was
designed to enroll up to 145 patients at more than 30 hospitals in
North America. The study population includes patients with
end-stage heart failure who have not responded to standard medical
management and who are eligible for cardiac transplantation.
"This study will not only provide the medical community with
clinical data on patient outcomes following implantation via
thoracotomy, but it also will help to develop best practices for
surgical implantation of the HVAD via a minimally invasive
approach," said Anson Cheung, M.D.,
Surgical Director of the Cardiac Transplantation Program of
British Columbia and Clinical
Professor of Surgery at the University of
British Columbia, Department of Surgery, Division of
Cardiovascular Surgery and a co-principal investigator of the
trial. "Clinical data from the LATERAL Study have the
potential to confirm the observations from prior, single-center
studies evaluating the thoracotomy technique and to help facilitate
a discussion of innovative surgical implantation techniques to
achieve optimal patient outcomes."
"The LATERAL study represents one of our key initiatives to
leverage the versatility of the HVAD Pump's compact size into
clinical benefits for the physician, patient and payer," said
Doug Godshall, President and Chief
Executive Officer at HeartWare. "We would like to thank the
investigators, coordinators and entire heart team at each hospital
site participating in this trial, as well as the cardiovascular
surgeons for investing the resources necessary to learn and
implement a new, promising surgical implant technique."
About the HeartWare® Ventricular Assist
System
The HVAD System is HeartWare's flagship product and
features the world's smallest full-support circulatory assist
device, the HVAD Pump, which is designed to be implanted next to
the heart, avoiding the abdominal surgery generally required to
implant other devices. The HeartWare System received CE
Marking in the European Union in 2009 and was approved by the U.S.
Food and Drug Administration in 2012 as a bridge to cardiac
transplantation for patients who are at risk of death from
refractory end-stage left ventricular heart failure. The
device is also currently the subject of a U.S. clinical trial for
destination therapy. Today, more than 10,000 patients with
advanced heart failure in 47 countries around the world have
received the HVAD System.
About HeartWare International
HeartWare International
develops and manufactures miniaturized implantable heart pumps, or
ventricular assist devices, to treat patients around the world
suffering from advanced heart failure. Dedicated to
developing new, minimally invasive technologies to revolutionize
the treatment of patients with end-stage heart failure, HeartWare
has multiple technologies in development to offer progressively
less-invasive mechanical circulatory support options.
HeartWare's corporate headquarters are located in Framingham, Massachusetts, and the company has
technology, operations, manufacturing and distribution centers in
Miami Lakes, Florida; Arden Hills, Minnesota; and Hannover, Germany. For additional
information about the company, please visit www.heartware.com.
HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare
logos are trademarks of HeartWare, Inc. or its
affiliates.
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: commercialization of the HeartWare HVAD System;
timing, progress and outcomes of clinical trials; potential
benefits of alternative implantation techniques; and regulatory
submissions. 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, except as may be required by federal securities laws
and the rules and regulations of the Securities and Exchange
Commission (SEC). 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 SEC. 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 SEC.
For additional information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com
Phone: +1 508 739 0864
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SOURCE HeartWare International, Inc.