Thoratec
Corporation (Nasdaq: THOR), a world leader in products to treat
cardiovascular disease, said today that it has completed the submission of
its PMA (Pre-Market Approval) seeking bridge-to-transplantation (BTT)
approval for its HeartMate II LVAS (left ventricular assist system) by
filing the clinical summary and draft final labeling module.
On October 31, 2006, Thoratec announced that it had filed the first two
modules of the PMA that addressed all of the supporting engineering and
preclinical studies, as well as manufacturing and quality systems. At that
time, the company indicated that it would file the clinical module once the
necessary number of patients reached the efficacy endpoint and it completed
the full analysis of outcomes, adverse events and all other secondary
endpoints.
The PMA filing is based on data from 133 BTT patients representing more
than 57 years of cumulative support. Days of support ranged from 1-568
days. Enrollment of these 133 patients was completed in May 2006, with 26
centers participating. The company continues to enroll additional BTT
patients under a Continued Access Protocol.
"We are delighted to have reached this critical milestone in the
HeartMate II BTT clinical trial process," said Gary F. Burbach, president
and chief executive officer of Thoratec. "We are encouraged by the positive
trial patient experience as has been reported in presentations at a number
of leading professional medical meetings. We look forward to a productive
dialogue with the FDA about this submission," he continued.
In addition, the company has a separate arm of the Pivotal trial
seeking approval for long-term use, or Destination Therapy (DT). Enrollment
in that arm is continuing, and as of October 26, 2006, 113 randomized
patients have been enrolled in the DT arm. This trial design calls for 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 powered by a rotary pumping mechanism, it 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 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 10,000
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 or itcmed.
Many of the preceding paragraphs, particularly but not excluding those
addressing future performance and growth, contain forward-looking
statements within the meaning of Section27A 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," 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.
Thoratec Corporation
thoratec
Thoratec Completes Filing Of PMA Seeking Bridge-to-Transplantation Approval For HeartMate(R) II
03
01
2016