Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate...

Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for
HeartMate II(R)

PLEASANTON, Calif., April 20 /PRNewswire-FirstCall/ -- Thoratec Corporation
(Nasdaq: THOR), a world leader in device-based mechanical circulatory support
therapies to save, support and restore failing hearts, said today that it has
filed a PMA (Pre-Market Approval) supplement with the FDA seeking to add the
intended use of Destination Therapy (DT) for the HeartMate II LVAS (left
ventricular assist system). The HeartMate II is a next generation heart assist
device designed to provide long-term cardiac support for patients suffering
from advanced stage heart failure. The device was approved for
Bridge-to-Transplantation (BTT) in the U.S. under the original PMA in April
2008.

The PMA filing includes data on a pivotal study cohort of 200 randomized
patients, including two-year data on the first 167 patients enrolled. Also
included in the primary analysis are data on 24 small BSA (body surface area)
patients who because of their body size could not be randomized to the larger
HeartMate XVE. The filing also provides data on adjunctive cohorts totaling
an additional 409 patients, including those who had been originally supported
by an XVE who then elected to receive a HeartMate II, based on the need for
device replacement, and patients enrolled under Continuous Access Protocols
(CAPs). The company plans to file an amendment to the PMA supplement
submission with complete two-year data on all 200 randomized patients at the
end of June.

"We are pursuing this approach and making this submission at this time based
on a series of discussions with the FDA. An interim analysis conducted at the
end of 2008 for the primary endpoint demonstrated statistically significant
superiority in favor of the HeartMate II versus the control group. As a
result, Thoratec and the FDA have agreed that it is appropriate to make this
filing now and to then file an amendment to the submission once we have
complete two-year data on the primary patient cohort," said Gary F. Burbach,
president and chief executive officer of Thoratec.

In December 2008, Thoratec received approval from the FDA to end randomization
in the trial, based on a pre-specified interim analysis of 67 percent of the
first 200 patients that showed that patients implanted with the HeartMate II
achieved statistically superior outcomes versus those in the control group who
were implanted with the HeartMate XVE. Based on that analysis, the study's
Data Safety Monitoring Board concurred with Thoratec's recommendation to
eliminate randomization for patients enrolled in the trial under FDA-approved
CAPs.

Patients in the trial were randomized to the HeartMate II or the HeartMate XVE
-- currently the only device approved for DT -- on a 2-1 basis, respectively.
The primary endpoint at two years is survival while remaining free from stroke
and the need for reoperation for pump repair or replacement. Secondary
endpoints included adverse events, functional status, hospitalization,
assessment of neuro-cognitive function and patient quality of life.

"The data from the trial demonstrate that the HeartMate II is superior to the
XVE, based on device performance and the primary patient outcome of two-year
survival free from stroke and reoperation for device replacement. The data
also showed that key adverse events, such as infection, sepsis and right heart
failure, were significantly lower for the HeartMate II versus the XVE. As a
result, this submission seeking FDA approval for Destination Therapy is an
important milestone in Thoratec's mission to bring breakthrough therapies and
new hope to the thousands of patients and their families suffering from
advanced heart failure, as well as the clinicians who work tirelessly to treat
them," Burbach said.

"The commercial experience of the HeartMate II for BTT over the past year has
been very encouraging with respect to positive patient outcomes and increased
adoption by the clinical community. We look forward to working with the FDA on
this submission and hope to achieve DT approval by early 2010," he added.

The HeartMate II is a continuous flow device designed to provide long-term
cardiac support for advanced-stage heart failure patients. An implantable LVAS
powered by a rotary pumping mechanism, the HeartMate II is designed to have a
much longer functional life than pulsatile devices and to operate more simply
and quietly. The device provides blood flow through the circulatory system on
a continuous basis with only one moving part. It is also smaller and easier to
implant than a pulsatile device.

Thoratec is a world leader in therapies to address advanced-stage heart
failure. The company's product lines include the Thoratec(R) VAD (Ventricular
Assist Device) and HeartMate LVAS with more than 13,000 devices implanted in
patients suffering from heart failure. Additionally, its International
Technidyne Corporation (ITC) division is a leader in point-of-care blood
testing and skin incision products. Thoratec is headquartered in Pleasanton,
California. For more information, visit the company's web sites at
http://www.thoratec.com or http://www.itcmed.com.

Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered
trademarks of Thoratec Corporation, and IVAD is a trademark of Thoratec
Corporation. ITC, A-VOX Systems, AVOXimeter, HEMOCHRON, ProTime and IRMA are
registered trademarks of International Technidyne Corporation. CentriMag is a
registered trademark of Levitronix LLC.

Many of the preceding paragraphs, particularly but not exclusively those
addressing future performance or timelines for regulatory approvals, contain
forward-looking statements within the meaning of Section 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," "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 markets including Destination Therapy, the growth of
existing markets for our products, customer and physician acceptance of
Thoratec products, changes in the mix of existing markets for our products,
the results of enrollment in and timing of clinical trials, including the
HeartMate II, the effects of FDA regulatory requirements and the effects of
healthcare reimbursement and coverage policies. Forward-looking statements
contained in this press release should be considered in light of 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 and as may be updated in subsequent SEC filings. These
forward-looking statements speak only as 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

David Smith, Executive Vice President, Chief Financial Officer of Thoratec
Corporation, +1-925-847-8600; or Neal Rosen of Ruder-Finn, +1-415-692-3058,
for Thoratec Corporation