- The MVAD System is a versatile, miniaturized and
hematologically advanced circulatory assist system designed for
full-support of patients with advanced heart failure -
FRAMINGHAM, Massachusetts,
July 20, 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 commencement of its MVAD® System CE Mark
international clinical trial. The first patients receiving
HeartWare's next-generation MVAD Pump were implanted at the Freeman
Hospital in Newcastle upon Tyne,
England, and at the Medical
University AKH Vienna in Austria.
Photo - http://photos.prnewswire.com/prnh/20150720/238128
The MVAD Pump is a heart pump that supports a wide range of
flows to enable circulatory support for patients with advanced
heart failure. The MVAD Pump was designed with a low shear
stress impeller and optimal blood flow paths, which together are
expected to result in improved hemodynamic performance. In
addition, the MVAD System incorporates a pulsatility algorithm
called the qPulse™ Cycle that allows physicians to customize the
device for each patient, providing four pulse settings designed to
enhance aortic valve function and reduce chronic bleeding
events.
"With the successful completion of these first implants in
Europe, we are taking the next
significant step in our efforts to help patients worldwide who
suffer from advanced heart failure," said Doug Godshall, President and Chief Executive
Officer at HeartWare. "The MVAD Pump is less than half the
size of our HVAD® Pump – currently the smallest
commercialized full-support device – and is designed to be
implanted through a less-invasive thoracotomy technique. In
addition, the MVAD System controller and battery unit, called
Peripherals for an Active Lifestyle (Pal™), is expected to greatly
enhance the user experience."
"We are encouraged by the initial implant and early
post-operative experience with the MVAD System and believe that the
benefits of this novel device have the potential to lead to better
patient outcomes and an improved quality of life for patients,"
said Professor Stephan Schueler,
M.D., Ph.D., Director of the Ventricular Assist Program at the
Freeman Hospital, and an investigator in HeartWare's MVAD System CE
Mark clinical trial.
The MVAD Pump, which weighs only 78 grams and displaces 22 cc of
volume, has a steerable sewing ring, which enables clinicians to
position the inflow cannula to facilitate optimal blood flow into
the pump. The integrated Pal controller and battery system
includes a touch-screen display and two sizes of small,
light-weight, snap-on batteries.
"Since the MVAD Pump requires a comparatively small thoracic
space, it will be even more conducive to minimally invasive implant
techniques, which is our preferred approach today with the
current-generation HVAD Pump," said Professor Daniel Zimpfer, M.D., Director of Mechanical
Circulatory Support, Medical University AKH Vienna, and an
investigator in HeartWare's MVAD System CE Mark clinical
trial. "The MVAD device has the potential to reduce surgical
trauma, enable use of fewer blood products during the procedure,
decrease adverse events and lower post-implant hospitalization
time. Reducing the invasiveness of the surgery will not only
enable us to treat a greater proportion of patients with heart
failure but may offer a more attractive option to patients at an
earlier stage of the disease progression."
The CE Mark trial is a multicenter, prospective, non-randomized,
single-arm trial that evaluates the clinical safety and performance
of the HeartWare MVAD System for the treatment of advanced heart
failure. The trial will enroll 60 patients at 11 sites in the
United Kingdom, Austria, Australia, France and Germany (pending final regulatory approval
from BfArM). In the trial, patients will be implanted with
the MVAD Pump via sternotomy or thoracotomy, and the device will be
evaluated for short- and long-term use. The primary endpoint
is survival at six months.
HeartWare has submitted to the U.S. Food and Drug Administration
(FDA) an Investigational Device Exemption (IDE) seeking approval to
commence an MVAD System clinical trial in the United States.
Health Canada is also reviewing a submission for a 15-patient,
three-center study, which is expected to commence later this
year.
About HeartWare International
HeartWare International
develops and manufactures miniaturized implantable heart pumps, or
ventricular assist devices, to treat patients suffering from
advanced heart failure. HeartWare's HVAD® 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 HVAD System is approved in
the U.S. 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 42 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.
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 progress and
outcomes of clinical trials, regulatory status, approved
indications, research and development activities and
commercialization of the MVAD and HVAD Systems. 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.
HEARTWARE, HVAD, MVAD, PAL, SYNERGY, CIRCULITE and HeartWare
logos are trademarks of HeartWare, Inc. or its affiliates.
For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864