Investigators Report Data from First Cohort in Destination
Therapy at the 35th Annual International Society for
Heart and Lung Transplantation Meeting in Nice, France
- Investor Breakout Session and Clinician Symposium to be
Webcast Today -
FRAMINGHAM, Massachusetts and
NICE, France, April 16, 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 data from its first destination therapy clinical
trial cohort, ENDURANCE, successfully demonstrated that the trial
achieved the primary endpoint.
Photo - http://photos.prnewswire.com/prnh/20150415/199018
Results from HeartWare's ENDURANCE clinical trial were presented
today during the Opening Plenary Session at the 35th
International Society for Heart and Lung Transplantation (ISHLT)
Annual Meeting in Nice,
France.
HeartWare's ENDURANCE clinical trial is a prospective,
randomized, controlled, un-blinded Investigational Device Exemption
(IDE) study designed to evaluate the HeartWare®
Ventricular Assist System as a destination therapy - or long-term
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 U.S. hospital centers
and 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.
Investigators for the study today reported that 55.0% of the
investigational device patients attained the primary endpoint of
the trial, which is 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. In
comparison, 57.4% of patients in the control arm achieved the
primary endpoint of the study. Based on these results for the
primary endpoint of the ENDURANCE study, non-inferiority of the
investigational device was established (p=0.0060).
"As the largest, randomized, destination therapy trial to date
involving ventricular assist devices, the observations from
ENDURANCE demonstrate the potential of the HeartWare System as a
longer term treatment option for advanced heart failure patients
who have exhausted medical therapy and are ineligible for a heart
transplant," said Francis D. Pagani,
M.D., Ph.D., a co-principal investigator for ENDURANCE, surgical
director of the Adult Heart Transplant Program and director of the
Center for Circulatory Support at the University of Michigan Health System.
"Survival with the HVAD Pump at two years was comparable to
the control device. HVAD device and design improvements,
including sintering of the inflow cannula, resulted in improvements
in outcomes, including a marked reduction in pump thrombosis."
Among the 200 patients who received the investigational device
with a sintered inflow cannula, an enhancement granted by FDA in
April 2011, 57.5% attained the
primary endpoint.
Today, the HeartWare System, featuring the HVAD® Pump, is only
available with the enhanced sintered inflow. Sintering
titanium is a process by which minute beads are metallurgically
affixed to a titanium surface and is commonly used in medical
devices to facilitate tissue adhesion at the sintered region.
Sintering of the HVAD Pump on the outer surface of the implanted
inflow tube is designed to promote tissue ingrowth on the lower
section of the inflow tube.
Secondary endpoints for ENDURANCE include adverse events such as
bleeding and infection, as well as functional status, assessment of
neuro-cognitive function and patient quality of life.
"Treatment with the investigational device was associated with
improvements in quality of life, NYHA functional classification,
and sustained improvement in the six-minute walk distance of more
than 90 meters," said Joseph Rogers,
M.D., senior vice chief for clinical affairs, Division of
Cardiology and Mechanical Circulatory Support Program at
Duke University, and a co-principal
investigator for ENDURANCE. "The observed stroke rate was
higher in the investigational device arm, whereas device
malfunctions leading to exchange or urgent transplant were more
frequent in the control group. Multivariate analysis
confirmed the previously-observed link between neurological events
and mean arterial pressure, as elevated blood pressure was the
strongest predictor of neurologic events."
"The breadth of clinical and commercial data presented at ISHLT
is extensive. We are grateful for the leadership of our
investigators and the commitment of our site coordinators for
ENDURANCE, as well as the dozens of other leading heart failure
surgeons and cardiologists who continue to conduct research and
help us pursue opportunities to optimize outcomes for patients,"
said Doug Godshall, President and
CEO at HeartWare. "Attaining the primary endpoint in this
first cohort is encouraging, yet we view it as our core mission to
continually improve patient outcomes with the HeartWare
System. Just as we made enhancements to the device and
implant procedure during the ENDURANCE enrollment period of 2010 to
2012, we are similarly making improvements to patient management
and look forward to confirming the benefits of more consistent
blood pressure monitoring in the second cohort of our destination
therapy trial which is nearing full enrollment."
Enrollment in Second Cohort for Destination Therapy Nearing
Completion
In the second destination therapy cohort,
HeartWare is enrolling up to 310 HVAD patients, as well as up to
155 control patients, in a 2:1 randomization at 50 centers.
The trial protocol approved by FDA was designed to confirm
observations from ENDURANCE, that sites adhering to more regular
monitoring and management of patient blood pressure witnessed a
notably lower incidence of neurological events. The primary
endpoint in the supplemental arm of the study is change in stroke
incidence at 12 months on the originally-implanted
device.
Enrollment for the destination therapy supplemental cohort
commenced in October 2013, and with
more than 80% of the study enrolled, HeartWare expects enrollment
to be completed in mid-2015. The company intends to
incorporate data from this second cohort into a Pre-Market Approval
(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-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 received CE Marking in the European Union
in 2009 and was approved by FDA in 2012 as a bridge to cardiac
transplantation for patients who are at risk of death from
refractory end-stage left ventricular heart failure. Last
week, HeartWare announced approval of the HeartWare System as a
bridge to heart transplantation from Health Canada. Today,
more than 8,000 advanced heart failure patients globally have
received the HeartWare System.
Investor Breakout Session and Webcast
Following the
data presentation today, HeartWare CEO Doug
Godshall will host an investor breakout session at
3:00 p.m. local time (9:00 a.m. U.S. Eastern Time) in Gallieni 4 at the
Acropolis Congress Center in Nice,
France. A live webcast of HeartWare's investor meeting will
be available to the public at
http://edge.media-server.com/m/p/efpikrgn and through the investor
section of the company's website at www.heartware.com. A
replay of the webcast will be available through the above weblink
shortly following completion of the call. The call may be
accessed by dialing +1-844-241-2668 five minutes prior to the
scheduled start time and entering conference ID 24958161. For
callers outside the U.S., dial +1-678-509-7640.
HeartWare Symposium at ISHLT
HeartWare will host a
lunch symposium titled, "Deeper Dive into HeartWare Clinical and
Real-World Results," on Thursday, April 16,
2015 from 12:45 p.m. to 2:15
p.m. local time (6:45 a.m. to 8:15
a.m. U.S. Eastern Time). The meeting will be held in
the Clio/Thalie room at the Acropolis Congress Center.
Clinicians from the U.S. and Europe will highlight clinical and commercial
experience with the HeartWare System, including discussions of the
oral presentations detailed below.
An audio feed of the symposium will be available to the public
via webcast at http://edge.media-server.com/m/p/fwekfebu and
through the investor section of the company's website at
www.heartware.com. A replay of the webcast will be available
through the above weblink shortly following completion of the call.
The audio of the symposium may be accessed by dialing
+1-844-241-2668 five minutes prior to the scheduled start time and
entering conference ID 23527974. For callers outside the
U.S., dial +1-678-509-7640.
Other Highlighted ISHLT Presentations
In addition to
Dr. Pagani's presentation on behalf of the ENDURANCE investigators
entitled, "HeartWare HVAD for the Treatment of Patients with
Advanced Heart Failure Ineligible for Cardiac Transplantation:
Results of the ENDURANCE Destination Therapy Trial," other
highlighted ISHLT presentations include:
- Professor Thomas Krabatsch,
M.D., Ph.D., Berlin Heart Center, Germany, will deliver a presentation entitled,
"The HeartWare HVAD Pump in Clinical Practice - Results from
1,035 Patients Analyzed in a Retrospective European Multi-Center
Study," in which the investigators concluded that the HeartWare
System has found broad acceptance in recent years, offers great
versatility in implant strategies; and shows an acceptably low
complication profile.
- Simon Maltais, M.D., Ph.D.,
Vanderbilt University Medical Center,
will present, "Neurological Events in Patients Bridged with
Long-Term Mechanical Circulatory Support: A Device Specific
Comparative Analysis" results from a multi-center study of
1,064 continuous flow LVAD implants in the U.S. Investigators
concluded that the risk of neurological complications is comparable
between the HeartMate II and HVAD devices in a contemporary cohort
of patients bridged to transplantation with a CF-LVAD, with
advanced age remaining the primary determinant of neurological
events.
- Jan Schmitto, M.D., Ph.D., MBA,
Hannover Medical School, Germany,
will present, "Long Term Support of Patients Receiving an LVAD
for Advanced Heart Failure: A Subgroup Analysis of the Registry to
Evaluate the HeartWare® Left Ventricular Assist System
(The REVOLVE Registry)," which is an investigator-initiated
registry established to collect post-CE Mark clinical data on
patients receiving the HeartWare System in the European Union and
Australia. The study showed that
real-world use of the HVAD Pump continues to support the excellent
outcomes experienced with the device, and, due to the low rate of
transplantation, successful long-term support is observed in a
significant cohort of patients receiving the device.
- And yesterday, Dr. Maltais presented a poster titled,
"Update on Post-Approval INTERMACs Registry of the HVAD System
in Commercial Use," a registry established to collect clinical
data on 600 patients receiving the HeartWare System in the U.S. in
a commercial setting. The investigators concluded that HVAD
continues to provide excellent outcomes and quality of life
improvements in commercial use. Despite a sicker population,
patient survival and adverse event profiles in this study were
similar to those observed in HeartWare's ADVANCE
Bridge-to-Transplant clinical trial and related Continued Access
Protocol cohorts.
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, 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 progress and
outcomes of clinical trials and registries, regulatory status,
research and development activities and commercialization of the
HeartWare® Ventricular Assist System. 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