Thoratec Announces First HeartMate III™ Human Implant And Start Of CE Mark
PLEASANTON, Calif., June 27, 2014
PLEASANTON, Calif., June 27, 2014 /PRNewswire/ --Thoratec Corporation
(NASDAQ: THOR), a world leader in device-based mechanical circulatory support
therapies to save, support and restore failing hearts, said today that its CE
Mark Clinical Trial for HeartMate III™ commenced with the first patient
implanted with this new device.
"We are pleased to reach this significant clinical milestone with an important
pipeline product," said Gary F. Burbach, President and Chief Executive
Officer. "We are also excited about the potential for HeartMate III to
advance heart failure therapy, improve clinical outcomes and enhance the
patient experience," he added.
HeartMate III is a centrifugal-flow chronic left ventricular assist system.
The fully magnetically levitated technology foundation of HeartMate III is
designed to lower adverse event rates through improved hemocompatibility while
enhancing ease of surgical placement through a compact size.
The Hannover Medical School in Hannover, Germany performed the first human
implant of HeartMate III under the direction of surgeon Jan Schmitto, M.D.,
Ph.D. and Professor Axel Haverich M.D., chief of the Cardiothoracic,
Transplantation and Vascular Surgery Department at the Hannover Medical
School. "I am highly enthusiastic about the potential for HeartMate III based
on its elegant implant technique and the promise of improved clinical
outcomes," commented Dr. Schmitto. This implant marked the first patient
enrolled in the HeartMate III CE Mark Clinical Trial, which will enroll up to
50 patients at nine sites in Europe, Australia, and Canada. The study
includes a primary endpoint of six-month survival compared with estimated
mortality based on the Seattle Heart Failure Model.
In addition to the first implant performed by Dr. Schmitto in Hannover,
Germany, enrollment of the HeartMate III CE Mark Trial has also commenced at
the Vienna Medical University in Vienna, Austria with an implant under the
direction of Daniel Zimpfer M.D., Director of Mechanical Circulatory Support
and Professor Gunther Laufer M.D., Head of the Department of Cardiac Surgery.
"We are very pleased to participate in this important study that will help to
advance the field of mechanical circulatory support with next generation LVAD
technology from Thoratec," said Dr. Zimpfer.
Thoratec is a world leader in therapies to address advanced-stage heart
failure. The company's products include the HeartMate II and HeartMate III
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 and distributes the CentriMag® and
PediMag®/PediVAS® product lines. Thoratec is headquartered in Pleasanton,
California. For more information, visit the company's website at
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 FDA or foreign
regulatory authority 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
Contact: Neil Meyer, Director of Investor Relations, Thoratec Corporation,
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