FRAMINGHAM, Mass., April 9, 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 that it has received approval from Health Canada, the
country's federal department responsible for helping Canadians
maintain their health, to market the HeartWare®
Ventricular Assist System as a bridge to heart transplantation in
patients with end-stage heart failure.
"We gained valuable experience with the HeartWare®
System under Health Canada's Special Access program and found it to
be an important addition to our treatment options, particularly
with difficult-to-treat patients," said Vivek Rao, M.D., Ph.D., M.S., FRCSC, Chief of
Cardiovascular Surgery and Director of Mechanical Circulatory
Support at the Peter Munk Cardiac Centre, University Health Network
in Toronto. "With Health Canada approval, we look forward to
continuing our positive experience with this device."
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.
"Approximately the size of a golf ball, the small HVAD Pump
allows for ease of implantation and pursuit of less invasive
surgical approaches," said Anson
Cheung, M.D., B.S., M.S., FRCSC, Director of Cardiac
Transplant at St. Paul's Hospital
in Vancouver, and Professor of
Surgery at the University of British Columbia. "Since 2010,
we've been able to build an extensive and positive clinical
experience with the HVAD Pump. Earlier this year, we
commenced LATERAL, a clinical trial to examine the potential
benefits of implanting this device through a less invasive left
thoracotomy technique, as an alternative to the sternotomy approach
associated with many cardiac surgeries."
"We are grateful for the efforts of the leading heart failure
specialists in Canada who have
worked diligently to gain an understanding of the attributes of the
HeartWare System and share insights as we worked toward commercial
approval," said Doug Godshall,
President and CEO at HeartWare. "We look forward to
demonstrating the benefits of the HeartWare System in a larger
patient population in Canada, as
we gain commercial experience with this device in an important new
geography."
The HeartWare Ventricular Assist System received U.S. Food and
Drug Administration (FDA) approval in 2012 as a bridge to heart
transplantation in patients with end-stage heart failure. The
HeartWare System has been the leading ventricular assist device
implanted in patients outside of the
United States for the last three years, having received CE
Marking in the European Union in 2009 and Australian Therapeutic
Goods Administration (TGA) approval in 2011. Today, more than
8,000 advanced heart failure patients globally have received the
HVAD Pump.
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 41 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 the HeartWare
System and 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 additional information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com
Phone: +1 508 739 0864
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SOURCE HeartWare International, Inc.