PLEASANTON, Calif.,
Sept. 9, 2014 /PRNewswire/ --
Thoratec Corporation (NASDAQ: THOR), a world leader in device-based
mechanical circulatory support therapies to save, support and
restore failing hearts, announced today that it has begun to enroll
patients in the HeartMate III™ U.S. clinical trial.
"We are excited to continue our recent pipeline progress with
the start of the U.S. clinical trial for HeartMate III," said
Gary F. Burbach, President and Chief
Executive Officer. "Our innovative U.S. trial design allows
for the evaluation of patients for both short-term and long-term
support, and we are particularly enthusiastic about the potential
for HeartMate III to drive future growth of both the LVAD market
and Thoratec," he added.
HeartMate III is a centrifugal-flow chronic left ventricular
assist system. The fully magnetically levitated technology
foundation is designed to lower adverse event rates through
improved hemocompatibility, while HeartMate III also enhances ease
of surgical placement through a compact size. In addition to
the current U.S. IDE trial, patient enrollment continues in the
HeartMate III CE Mark clinical trial, which began in
June.
James Long M.D. Ph.D., Director
of INTEGRIS Advanced Cardiac Care and Medical Director of the Nazih
Zuhdi Transplant Institute at INTEGRIS Baptist Medical Center in
Oklahoma City, Oklahoma performed
the first HeartMate III implant in the U.S. Dr. Long and his
team have a well-established history of innovation in mechanical
circulatory support, including participation in clinical trials for
every previous HeartMate technology. "We look forward to
further enrollment in this important study for the field, and the
opportunity to demonstrate the potential benefits of the unique
fully magnetically levitated technology of HeartMate III,"
commented Dr. Long. Additionally, Douglas Horstmanshof M.D., Co-Director of
INTEGRIS Advanced Cardiac Care at INTEGRIS Baptist Medical Center
added, "HeartMate III represents an exciting technology with the
potential to advance the treatment of heart failure and improve
quality of life for the large number of untreated patients that
could benefit from chronic circulatory support."
The HeartMate III U.S. clinical trial is a randomized
non-inferiority study comparing HeartMate III with HeartMate II®™
and includes a primary endpoint of survival free of device
replacement and debilitating stroke. The trial began
enrollment in a safety phase under conditional approval from the
FDA for 30 patients at five sites. Enrollment will broaden to
up to 60 sites following full approval from the FDA based on 30-day
follow-up data from the initial safety phase. The first 294
randomized patients will be followed for six months to evaluate a
short-term indication such as Bridge-to-Transplantation. The
first 366 randomized patients will be followed for 24 months to
evaluate a long-term indication such as Destination Therapy.
The trial also allows for approximately 600 additional randomized
patients to be enrolled beyond the pivotal cohort in order to
assess secondary endpoints.
Thoratec is a world leader in therapies to address
advanced-stage heart failure. The company's products include
the HeartMate II® LVAS (Left Ventricular Assist Systems)
and Thoratec® VAD (Ventricular Assist Device) with more
than 20,000 devices implanted in patients suffering from heart
failure. Thoratec also manufactures the CentriMag® and
PediMag®/PediVAS® product lines. Thoratec is
headquartered in Pleasanton,
California. For more information, visit the company's
website at http://www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are
registered trademarks of Thoratec Corporation and HeartMate III,
HeartMate PHP, PVAD, IVAD and Pocket Controller are trademarks of
Thoratec Corporation. CentriMag and PediMag are registered
trademarks of Thoratec LLC, and PediVAS is a registered trademark
of Thoratec Switzerland GmbH.
The preceding paragraphs contain forward-looking statements
within the meaning of Sections 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. These
statements can be identified by the words, "believes," "views,"
"expects," "plans," "projects," "should," "hopes," "could," "will,"
"estimates," "potential," and other similar words. Actual results,
events or performance could differ materially from these
forward-looking statements based on a variety of factors, many of
which are beyond Thoratec's control. Therefore, readers are
cautioned not to put undue reliance on these statements. Investors
are cautioned that all such statements involve risks and
uncertainties, including risks related to regulatory approvals, the
development of new products, including development and clinical
trial timing, the growth of existing markets for our products,
customer and physician acceptance of Thoratec products, the effects
of international and FDA regulatory requirements, our ability to
address quality issues adequately and on a timely basis without a
resulting recall of products or interruption of manufacturing or
shipment of products, the effects of healthcare reimbursement and
coverage policies, and the effects of competition. Forward-looking
statements contained in this press release should be considered in
light these factors and those factors discussed from time to time
in Thoratec's public reports filed with the Securities and Exchange
Commission, such as those discussed under the heading, "Risk
Factors," in Thoratec's most recent annual report on Form 10-K,
quarterly reports on Form 10-Q, current reports on Form 8-K and
other SEC filings. These forward-looking statements speak only as
of the date hereof. Thoratec undertakes no obligation to publicly
release the results of any revisions to these forward-looking
statements that may be made to reflect events or circumstances
after the date hereof, or to reflect the occurrence of
unanticipated events.
SOURCE Thoratec Corporation