Thoratec Announces Completion of Enrollment in Bridge-to-Transplantation Arm of HeartMate(R) II Pivotal Trial
31 May 2006 - 11:30PM
PR Newswire (US)
PLEASANTON, Calif., May 31 /PRNewswire-FirstCall/ -- Thoratec
Corporation (NASDAQ:THOR), a world leader in products to treat
cardiovascular disease, today said that it has completed enrollment
in the Bridge-to-Transplantation (BTT) arm of its HeartMate II
Pivotal trial by implanting 133 patients. "This marks an important
milestone in our HeartMate II program, as we have now enrolled the
number of patients called for in the original trial design and we
achieved this goal within 15 months of the trial's initiation. We
continue to be encouraged by the positive patient experience in the
trial as reported in recent data presentations at leading
professional medical meetings," said Gary F. Burbach, president and
chief executive officer of Thoratec. "At the same time, we are
pleased that BTT patients will be able to continue to receive the
device under our Continued Access Protocol (CAP) and we expect that
centers will begin enrolling these new patients within the next few
days," he added. On May 16, 2006, Thoratec announced that the FDA
had approved an IDE (Investigational Device Exemption) supplement
that allows enrollment of up to an additional 90 patients in the
BTT arm of the pivotal trial. Bridge-to-Transplant patient
enrollment under the CAP allows continued enrollment in the 40
centers participating in the trial, subject to IRB approvals at the
centers. The CAP patients will be enrolled and followed under the
original protocol of the pivotal trial. The addition of these
patients will not impact the timing for the company's planned
submission of a PMA (PreMarket Approval) seeking FDA approval of
the HeartMate II for the BTT indication. In addition, the company
continues to enroll patients in the Destination Therapy (DT) arm of
the pivotal trial, which involves 200 total patients randomized to
the company's HeartMate XVE on a 2-1 basis. The HeartMate II is a
continuous flow device designed to provide long-term cardiac
support for advanced-stage heart failure patients. An implantable
LVAS (Left Ventricular Assist System) powered by a rotary pumping
mechanism, it is significantly smaller than currently approved
devices. 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.
It is also smaller and easier to implant than pulsatile devices.
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 LVAS with more than 10,000 devices
implanted in patients suffering from heart failure. Thoratec's
product line also includes the Vectra(R) VAG (Vascular Access
Graft) for patients undergoing hemodialysis. 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 http://www.thoratec.com/ or http://www.itcmed.com/.
Some of the preceding paragraphs, particularly but not exclusively
those addressing timelines and milestones for clinical trials,
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," "projects," "hopes," "believes," "could," 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 and the regulatory approval processes.
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 quarterly report on Form 10-Q. 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. DATASOURCE:
Thoratec Corporation CONTACT: investors, Cynthia Lucchese of Senior
Vice President, Chief Financial Officer of Thoratec Corporation,
+1-925-847-8600; or Neal Rosen of Kalt Rosen & Co.,
+1-415-397-2686, for Thoratec Corporation; or media, Jessica
Volchok, 1-310-577-7870, ext. 140, or , or Jennifer Chan,
+1-310-577-7870, ext. 164, or , both of FischerHealth, Inc., for
Thoratec Corporation Web site: http://www.thoratec.com/
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