FRAMINGHAM, Mass., Aug. 10, 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 enrollment in the ENDURANCE2 destination therapy
clinical trial has been completed. ENDURANCE2 is the largest
destination therapy clinical trial of a ventricular assist device
conducted to date and is designed to evaluate patients implanted
with the HeartWare® Ventricular Assist System for
long-term use as destination therapy in the United States. Data from the
ENDURANCE program are expected to form the basis for a Pre-Market
Approval (PMA) Application seeking approval of the HeartWare System
for destination therapy.
"This trial supports our commitment to studying enhanced patient
management strategies and identifying best practices for patients
who receive the HeartWare System," said Joseph Rogers, M.D., interim chief of the
Division of Cardiology at Duke
University, and a co-principal investigator for ENDURANCE2.
"Optimizing patient care is a critical component of our ongoing
focus to improve patient outcomes with mechanically assisted
circulation."
"We are delighted to have completed enrollment in this important
study and would like to thank the investigators, coordinators and
entire heart team at each hospital site for participating in this
trial and for focusing on improved patient management," said
Doug Godshall, President and CEO at
HeartWare. "This second phase of our destination therapy
trial reflects HeartWare's commitment to research and to the
betterment of patient outcomes."
ENDURANCE2, a supplemental cohort of HeartWare's ENDURANCE
destination therapy trial, is a prospective, randomized,
controlled, unblinded, multi-center evaluation of the stroke
incidence in patients implanted with an HVAD® Pump who
receive optimal blood pressure management. The study was
designed to enroll 465 patients at one of the 50 participating
hospital centers in the U.S. Patient enrollment occurred
between October 2013 and August 2015, and patients were randomly selected
to receive either the HeartWare Ventricular Assist System or, as
part of a control group, any alternative left ventricular assist
device (LVAD) approved by the U.S. Food and Drug Administration
(FDA) for destination therapy, in a 2:1 ratio. The primary
endpoint of the trial is incidence of neurologic injury at 12
months on the originally implanted device, and the endpoint will be
tested for non-inferiority versus the control device.
ENDURANCE Destination Therapy Trial: Primary Endpoint
Met
In April 2015, results
from the first HeartWare Ventricular Assist System destination
therapy clinical trial cohort, ENDURANCE, were presented at the
International Society for Heart and Lung Transplantation (ISHLT)
annual meeting in Nice, France.
The data presented demonstrated that the trial successfully
achieved the primary endpoint of stroke-free survival (Modified
Rankin Score ≥4) at two years, defined as alive on the originally
implanted device, transplanted or explanted due to patient
recovery.
"We have learned a great deal since the first cohort of the
ENDURANCE trial completed enrollment three years ago," said
Francis D. Pagani, M.D., Ph.D., a
co-principal investigator for ENDURANCE2, and surgical director of
the Adult Heart Transplant Program and director of the Center for
Circulatory Support at the University of
Michigan Health System. "The ENDURANCE data presented
at the ISHLT conference last spring reflected a learning curve, as
the clinical community gained experience over time in patient care
with the HeartWare System. We hope the data from this
additional cohort of destination therapy patients will further that
continuum of learning, so that we can continue to enhance
management techniques and improve patient outcomes."
HeartWare's ENDURANCE clinical trial is a prospective,
randomized, controlled, unblinded Investigational Device Exemption
(IDE) study designed to evaluate the HeartWare Ventricular Assist
System as a destination therapy for patients with end-stage heart
failure who are ineligible for heart transplantation. Between
August 2010 and May 2012, 446 patients were enrolled at 48
hospital centers in the U.S. and were randomly selected to receive
either the HeartWare Ventricular Assist System or, as part of a
control group, any alternative LVAD approved by FDA for destination
therapy, in a 2:1 ratio.
HeartWare intends to incorporate data from ENDURANCE and
ENDURANCE2 in a PMA application, which HeartWare anticipates
submitting to FDA next year, seeking approval of the HeartWare
System for the destination therapy indication.
HeartWare® Ventricular Assist System
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 HVAD
Pump, with sintered inflow cannula, weighs approximately five
ounces and displaces a volume of approximately 50
milliliters. The HeartWare Ventricular Assist System received
FDA approval in 2012 as a bridge to heart transplantation in
patients who are at risk of death from refractory end-stage left
ventricular heart failure.
The HeartWare System is currently the leading ventricular assist
device implanted in patients outside of the United States, having received CE Marking
in the European Union in 2009 and Australian Therapeutic Goods
Administration (TGA) approval in 2011. Today, more than 9,000
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 46 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 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®
Ventricular Assist System; timing, progress and outcomes of
clinical trials; regulatory and quality compliance; research and
development activities and our ability to take advantage of
acquired and pipeline technology. 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.