Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of HeartMate...

Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of
HeartMate II(R) for Bridge-to-Transplantation

PLEASANTON, Calif., Nov. 30 /PRNewswire-FirstCall/ -- Thoratec Corporation
(Nasdaq: THOR), a world leader in products to treat cardiovascular disease,
said today that the FDA Circulatory System Devices Advisory Panel has
recommended unanimously that the agency approve, with conditions, the
company's PMA (PreMarket Approval) allowing the use of its HeartMate II LVAS
(Left Ventricular Assist System) as a bridge-to-transplantation (BTT).
The HeartMate II is a continuous flow device designed to provide long-term
cardiac support for advanced-stage heart failure.
"We are delighted with the panel's recommendation indicating their belief
that the data demonstrate the safety and efficacy of the device. This
represents a major step in our program to make this state-of-the-art
circulatory support technology commercially available in the U.S. for patients
suffering from advanced-stage heart failure," said Gary F. Burbach, president
and chief executive officer of Thoratec. "We believe the data reflect the
positive experience of patients in the trial and that the HeartMate II
represents a significant breakthrough in the treatment of heart failure and
look forward to continuing what has been to date a positive dialogue with the
FDA around this submission and achieving approval," he added.
The leading clinical presenters were Dr. Leslie Miller, Walters Chair of
Cardiovascular Medicine and Director of Cardiology Programs at Washington
Hospital Center & Georgetown University Hospital, and Dr. Francis Pagani,
Director, Heart Transplant Program, University of Michigan Hospital.
The conditions outlined in the panel's recommendations related to
clarifications on labeling for the device regarding small patients and those
unable to be treated with anti-coagulation therapy, and elements of the
post-approval study.
An implantable LVAS powered by a rotary pumping mechanism, the HeartMate
II is significantly smaller than currently approved devices, enabling an
easier implantation in a broader population of patients. The HeartMate II is
designed to have a much longer functional life than other approved 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.
Thoratec Corporation is a world leader in hemodynamic restoration
therapy-developing products to treat cardiovascular disease. The company's
product line includes the Thoratec(R) VAD (Ventricular Assist Device) and
HeartMate II LVAS with more than 11,000 devices implanted in patients
suffering from heart failure. Additionally, its International Technidyne
Corporation (ITC) division supplies blood testing and skin incision products.
Thoratec is headquartered in Pleasanton, California. For more information,
visit the company's web sites at www.thoratec.com or itcmed.com.
Many of the preceding paragraphs, particularly but not excluding those
addressing future performance, 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 "expects," "believes," "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 the results of
enrollment in and timing of clinical trials, including the HeartMate II,
regulatory approval processes, the development of new markets, including
Destination Therapy, the growth of existing markets for our products, customer
and physician acceptance of Thoratec products, 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 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

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