Thoratec Announces Approval for HeartMate II® in Japan
PLEASANTON, Calif., Dec. 11, 2012
PLEASANTON, Calif., Dec. 11, 2012 /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
the company has received approval from Japan's Ministry of Health, Labour and
Welfare to market HeartMate II® ^ as a Bridge-to-Transplantation therapy for
patients suffering from advanced heart failure.
"Approval in Japan marks a significant milestone in Thoratec's efforts to
disseminate HeartMate II to advanced heart failure patients worldwide," said
Gary F. Burbach, President and Chief Executive Officer. "We are
enthusiastically preparing to launch HeartMate II into this important market."
To support Japanese approval, Thoratec and its distribution partner, Nipro
Corporation, conducted a confirmatory clinical study, which enrolled six
patients at five institutions. At over two years of follow-up, all six
patients are alive, with three having been transplanted and the other three
still supported by the device. "We have been highly encouraged by the
performance of HeartMate II in Japan, and we look forward to working closely
with clinicians and Nipro to foster continued excellent clinical outcomes,"
Thoratec and Nipro anticipate a commercial launch of HeartMate II toward the
end of the first quarter of 2013, after centers have been trained and
reimbursement is in place. The initial launch will target approximately 15
hospitals, including the clinical trial centers as well as additional
institutions that are already accredited to perform ventricular assist device
(VAD) implant procedures. Nipro will have dedicated personnel in the field,
trained on HeartMate II, to provide sales, marketing and clinical support for
the launch. Thoratec will conduct all initial surgical training and will
support Nipro with additional resources as necessary.
Thoratec is the world leader in mechanical circulatory support with the
broadest product portfolio to treat the full range of clinical needs for
patients suffering from advanced heart failure. The company's products include
the HeartMate LVAS and Thoratec VAD, with more than 20,000 devices implanted
in patients suffering from heart failure. Thoratec also manufactures and
markets the CentriMag and PediMag / PediVAS product lines. Thoratec is
headquartered in Pleasanton, California. For more information, visit
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered
trademarks of Thoratec Corporation and IVAD is a trademark of Thoratec
Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC,
and PediVAS is a registered trademark of Thoratec Switzerland GmbH.
Many of the preceding paragraphs, particularly but not exclusively those
addressing guidance for fiscal 2012 financial results or future performance
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," "hopes," "could," "will," 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, and new markets including Destination Therapy, the
growth of existing markets for our products, customer and physician acceptance
of Thoratec products, the effects of FDA and Japanese regulatory requirements,
our ability to address issues raised by FDA or Japanese regulatory inspections
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: Investors, Taylor Harris, Vice President and Chief Financial Officer
of Thoratec Corporation, +1-925-738-0047; Media, Susan Benton Russell of
Benton Communications, +1-310-697-3488
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