HeartWare Receives FDA Approval for HeartWare® Ventricular Assist
System as a Bridge to Heart Transplantation for Patients with
Advanced Heart Failure
– First full-support, miniaturized ventricular assist device
approved in U.S. designed to be placed in the pericardial space
–
– HeartWare Management to Host Investor Conference Call Today at
3:00 pm ET –
FRAMINGHAM, Massachusetts and
SYDNEY, Nov. 20, 2012 /PRNewswire/ -- HeartWare
International, Inc. (Nasdaq: HTWR; ASX: HIN), 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 the United
States Food and Drug Administration (FDA) for the HeartWare®
Ventricular Assist System as a bridge to heart transplantation in
patients with end-stage heart failure.
(Photo: http://photos.prnewswire.com/prnh/20121120/LA17073)
The HeartWare® Ventricular Assist System features the HVAD®
pump, a small full-support circulatory assist device (up to 10L/min
flow) 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 5 ounces and displaces a volume of approximately 50
milliliters. The HeartWare System is intended for use as a
bridge to cardiac 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 2,500
advanced heart failure patients globally have received the HVAD®
pump.
"FDA approval marks the culmination of an extensive clinical
effort and represents an exciting advance in the treatment of
late-stage heart failure patients," said Doug Godshall, President and Chief Executive
Officer of HeartWare. "We wish to extend our most sincere
thanks to the patients, and to their families, for participating in
the study of this innovative device, and we also are grateful to
each of the nurses, coordinators, surgeons and cardiologists who
provided care to those patients."
Achieving long-standing goals
"I've had the opportunity to work on the HVAD® project since its
conception over a decade ago. The goal was to develop a
miniaturized device with an integrated inflow cannula that could be
placed within the pericardial sac, avoiding the necessity of
creating a pump pocket with its attendant infection risks, as well
as simplifying the surgical insertion," stated O.H. "Bud" Frazier,
MD; Chief, Center for Cardiac Support; Director, Cardiovascular
Surgery Research; and Co-Director, Cullen Cardiovascular Research
Laboratories, at Texas Heart Institute and a global pioneer in
mechanical circulatory support. "A second goal was
elimination of mechanical bearings to suspend the impeller,
designed to enhance durability and blood handling
characteristics. Those of us who treat these challenging
end-stage heart failure patients are fortunate to have this
pericardial, wearless system available for our patients."
Commencing Commercialization
"Our team is positioned to commence the commercial rollout of the
HeartWare System immediately, first facilitating broad use by the
50 U.S. hospitals that participated in our clinical studies, and
then with training and expansion to additional U.S. hospitals,"
added Mr. Godshall. "As always, HeartWare remains committed
to enhancing outcomes for patients with end-stage heart failure and
we will continue working to improve the overall clinical experience
with the HVAD."
HeartWare's pre-market approval (PMA) submission included data
from the Company's pivotal ADVANCE clinical trial, an FDA approved
Investigational Device Exemption (IDE) study designed to evaluate
the HeartWare System as a bridge to heart transplantation for
patients with end-stage heart failure. Under ADVANCE, 140
patients at 30 hospitals in the U.S. received the HeartWare
investigational device between August
2008 and February 2010.
The ADVANCE study achieved a 94% survival at 6 months and
successfully met its primary endpoint of establishing
non-inferiority between the investigational device and comparator
arm of the study, which was derived from contemporaneous patients
from the Interagency Registry for Mechanically Assisted Circulatory
Support (INTERMACS) [p<0.0001]. Four supplemental
allotments of patients have been granted by the FDA under a
Continued Access Protocol (CAP), encompassing more than 250
additional patients.
To help assure the continued safety and effectiveness of an
approved device, FDA requires a post-approval study (PAS) as a
condition of approval under 21 CFR 814.82(a)(2) to assess device
performance in a real-world setting. HeartWare's PAS is a
registry consisting of 600 patients who receive an HVAD and an
additional 600 control patients derived from a contemporaneous
group of continuous flow, intra-corporeal LVAD patients entered
into the INTERMACS database. The data for both arms of the
study will be entered into the INTERMACS registry by the implanting
centers. Other post approval commitments include the transfer
of patients from the ADVANCE IDE study into a post approval
database as well as an obligation to continue training sites in
accordance with an approved training program.
In other clinical development for the HeartWare Ventricular
Assist System, HeartWare has completed enrollment of a 450-patient
destination therapy study at 50 U.S. sites. The final
patients were implanted in May 2012,
with a two-year, primary endpoint follow-up period. HeartWare
has requested a Continued Access Protocol allocation for
destination therapy from the FDA.
Conference Call
HeartWare will host a conference call today at 3:00 p.m. U.S. Eastern Time to discuss approval
of the HeartWare® Ventricular Assist System as a bridge to heart
transplantation in patients with end-stage heart failure. The
call may be accessed by dialing 1-855-235-2089 five minutes prior
to the scheduled start time and referencing "HeartWare." For
callers outside the U.S., please dial +1-778-327-3988.
A live webcast of the call will also be available at the
Company's website (www.heartware.com) by selecting "HeartWare FDA
Approval Conference Call" under the section titled "Corporate
Presentations" on the Home Page. A replay of the conference
call will be available through the above weblink immediately
following completion of the call.
About HeartWare International
HeartWare International develops and manufactures miniaturized
implantable heart pumps, or ventricular assist devices, to treat
Class IIIB / IV patients suffering from advanced heart
failure. The HeartWare® Ventricular Assist System features
the HVAD® pump, a small full-output circulatory support 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, and has
received CE Marking in the European Union and has been used to
treat patients in 27 international 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 and the Australian Securities Exchange.
HEARTWARE®, HVAD®, MVAD® 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 progress of clinical trials and post-approval
studies, regulatory approvals, research and development activities
and commercialization strategies. 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.
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 our Annual Report on Form 10-K filed with the
Securities and Exchange Commission. We may update our risk
factors from time to time in Part II, Item 1A "Risk Factors" in our
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@heartwareinc.com
Phone: +1-508-739-0864