HeartWare Receives FDA Approval for HeartWare® Ventricular Assist System as a
Bridge to Heart Transplantation for Patients with Advanced Heart Failure
FRAMINGHAM, Massachusetts and SYDNEY, Nov. 20, 2012
– 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
HEARTWARE®, HVAD®, MVAD® and HeartWare logos are registered trademarks of
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
For further information :Christopher TaylorHeartWare International, Inc.Email:
firstname.lastname@example.org Phone: +1-508-739-0864
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