FRAMINGHAM, Mass., Jan. 13, 2015 /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 the first patient implant in the HVAD® LATERAL
Study, a U.S. Investigational Device Exemption (IDE) clinical trial
in which the HeartWare® Ventricular Assist System,
featuring the HVAD® Pump, is implanted through a
less-invasive thoracotomy procedure in patients with end-stage
heart failure who are awaiting a heart transplant.
The HVAD® LATERAL Study is designed to study the
clinical outcomes of this surgical technique. Currently,
commercially available ventricular assist systems are only approved
by the U.S. Food and Drug Administration for use with implantation
via median sternotomy, a common surgical approach in cardiac
surgery which utilizes a vertical incision through the center of
the patient's chest. With the less-invasive thoracotomy
approach, the HVAD® Pump, which is smaller than other
contemporary devices, is implanted using a small lateral
thoracotomy incision between the patient's ribs on the left side of
the chest.
"The thoracotomy implant technique holds considerable promise
for making implantation easier for the surgeon and better tolerated
by the patient," 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 Chicago Stritch
School of Medicine, and a Co-Principal Investigator for the
HVAD® LATERAL Study. "Implantation via thoracotomy
allows for preservation of a sternotomy for a heart transplant,
making that subsequent surgery less difficult for the
bridge-to-transplant patient."
The first clinical trial of a full-support ventricular assist
device (VAD) to utilize an implant technique other than sternotomy,
the HVAD LATERAL Study is a prospective, multi-center, single-arm
clinical trial which will enroll up to 120 patients at 30 U.S.
hospitals. The study population will include patients with
end-stage heart failure who have not responded to standard medical
management and who are eligible for cardiac transplantation.
The primary survival endpoint will be measured at six months
post-implant and compared to a performance goal. Patient
screening for implantation has begun at some sites, and may
commence immediately at each trial center, following Institutional
Review Board approval.
"Conducting this study will facilitate a robust discussion of
innovative surgical techniques, and development of best practices
to help achieve optimal patient outcomes," noted Anson Cheung, M.D., surgical director of cardiac
transplantation of British
Columbia and clinical professor of surgery at the
University of British Columbia,
Department of Surgery, Division of Cardiovascular Surgery and
Co-Principal Investigator of the trial.
"We have observed a marked increase in thoracotomy interest in
the U.S. and internationally, with more than 20 percent of global
HVAD implants in the past year performed via this less-invasive
method," said Doug Godshall,
President and CEO at HeartWare. "We are encouraged that
physicians are able to take advantage of the versatility of the
HVAD Pump and look forward to confirming the potential benefits of
the thoracotomy implant technique previously published through
single-center studies in the U.S. and Europe."
About HeartWare International
HeartWare International
develops and manufactures miniaturized implantable heart pumps, or
ventricular assist devices, to treat 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 40 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.
HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE 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 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®
Ventricular Assist System, the potential benefits of less invasive
implant techniques, clinical trials, regulatory status and research
and development activities. 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. 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@heartware.com
Phone: +1 508 739 0864
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SOURCE HeartWare International, Inc.