FRAMINGHAM, Mass., and
SYDNEY, June 17, 2013 /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 the U.S. Food and Drug Administration (FDA)
has granted conditional approval to an IDE (Investigational Device
Exemption) Supplement that allows HeartWare to commence enrollment
in an additional patient cohort for ENDURANCE, the Company's
pivotal, Destination Therapy clinical study.
ENDURANCE is a randomized, controlled, unblinded, multi-center
clinical trial to evaluate the use of the HeartWare®
Ventricular Assist System as a Destination Therapy in advanced
heart failure patients. The non-inferiority study completed
enrollment of 450 patients with end-stage heart failure who had not
responded to standard medical management and who were ineligible
for cardiac transplantation. Patients were randomly selected
to receive either the HeartWare Ventricular Assist System or, as
part of a control group, any alternative LVAD approved by the FDA
for Destination Therapy, in a 2:1 ratio.
The primary endpoint of the trial is stroke-free (Modified
Rankin Score > 4) survival at two years, defined as alive
on the originally implanted device, transplanted or explanted due
to patient recovery. Secondary endpoints include adverse events
such as bleeding and infection, as well as functional status,
hospitalization, assessment of neuro-cognitive function and patient
quality of life. The final implant was conducted in
May 2012, which will result in the
final patient reaching the two-year follow up point in May 2014.
Supplemental Patient Cohort
FDA granted conditional approval to a protocol 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.
In this supplemental cohort, HeartWare will enroll up to an
additional 240 HeartWare HVAD patients, as well as up to an
additional 120 control patients using a randomization scheme
consistent with the ENDURANCE protocol. Patients will be
followed for 12 months after implant. HeartWare intends to
incorporate the data from this new cohort into an anticipated
Pre-Market Approval (PMA) Application seeking approval of the
HeartWare System for the Destination Therapy indication.
Patient enrollment in this supplemental cohort can commence at
the 50 centers participating in the ENDURANCE clinical trial,
following edits to the protocol as prescribed by FDA and
Institutional Review Board approvals at each of the centers.
On November 20, 2012, FDA granted
approval of the HeartWare System for the Bridge-to-Transplant
indication. Concurrent with approval, the Company commenced a
post-approval study (PAS) 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. HeartWare expects enrollment for both arms of the
PAS will be complete by year's end.
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-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 30 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 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 status,
research and development activities and the commercial launch of
the HeartWare® Ventricular Assist System in the
U.S. 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
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 further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864
SOURCE HeartWare International, Inc.