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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.
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