Thoratec Announces the First Human Use of HeartMate PHP™
PLEASANTON, Calif., March 18, 2013
PLEASANTON, Calif., March 18, 2013 /PRNewswire/ -- Thoratec Corporation
(NASDAQ: THOR), a world leader in device-based mechanical circulatory support
(MCS) therapies to save, support, and restore failing hearts, announced today
that it has successfully completed the first human use of HeartMate PHP
(Percutaneous Heart Pump). The first PHP patient was supported for over 60
minutes during a high-risk percutaneous coronary intervention (HR PCI). The
patient was hemodynamically stable during the procedure, which involved
three-vessel intervention on a patient with an ejection fraction less than 30
percent. Two additional patients were treated as part of this first-in-man
series. The procedures were performed by Adrian Ebner, M.D. at Sanatorio
Italiano in Asuncion, Paraguay. Dr. Ebner is the Chief of the Cardiovascular
Department at Sanatorio Italiano.
The HeartMate PHP system is a catheter-based heart pump designed to provide
hemodynamic left ventricular support. Upon insertion into the femoral artery
via an integrated 12F introducer sheath, the PHP catheter is advanced into the
left ventricle where the distal end of the catheter expands to 24F, allowing
for enhanced blood flow with low levels of hemolysis. Thoratec has designed
the PHP system to facilitate rapid insertion using an intuitive control
console and to provide 4-5 liters per minute of mean flow for support
durations up to several days.
"We are delighted to have participated in the first human experience with
HeartMate PHP," said Dr. Ebner. "The PHP technology represents a potential
breakthrough in MCS therapy, providing the support required for
hemodynamically unstable patients. Without PHP in place during this high-risk
procedure, we might not have been able to achieve complete revascularization."
"I am pleased with the level of support the PHP system provided in this
milestone case," said Michael Ennen, Vice President and General Manager of
Thoratec's Interventional Business. "In just three years, our team has taken
PHP from concept to clinical utilization, and we look forward to advancing our
evaluation of this next-generation percutaneous support system."
Thoratec intends to pursue clinical investigations on the use of HeartMate PHP
to support patients undergoing high-risk percutaneous interventions as well as
those in cardiogenic shock, a population with persistently high mortality
rates. The company is planning a continuation of the pilot study during the
second quarter and anticipates initiating a CE Mark study in the second half
of 2013. The PHP system complements Thoratec's surgical-based MCS pump
platforms such as HeartMate II and CentriMag, providing a complete continuum
of circulatory support products.
"This First-in-Human experience with HeartMate PHP demonstrates Thoratec's
commitment to our mission of providing physicians with superior MCS solutions,
for both chronic and acute support needs, in order to dramatically improve
patient outcomes," said Gary Burbach, Thoratec's President and CEO.
Thoratec is the world leader in mechanical circulatory support with the
broadest product portfolio to treat the full range of clinical needs for
patients suffering from advanced heart failure. The company's products include
the HeartMate LVAS and Thoratec VAD, with more than 20,000 devices implanted
in patients suffering from heart failure. Thoratec also manufactures and
markets the CentriMag and PediMag / PediVAS product lines. Thoratec is
headquartered in Pleasanton, California. For more information, visit
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered
trademarks of Thoratec Corporation and HeartMate PHP and IVAD are trademarks
of Thoratec Corporation. CentriMag and PediMag are registered trademarks of
Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland
Many of the preceding paragraphs contain forward-looking statements within the
meaning of Sections 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," "projects," "hopes," "could,"
"will," "intends," 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 products and new markets, the growth of existing markets
for our products, customer and physician acceptance of Thoratec products, the
effects of FDA regulatory requirements, and the effects of competition.
Forward-looking statements contained in this press release should be
considered in light 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, quarterly reports on Form
10-Q, current reports on Form 8-K and other 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
Contact: Taylor Harris, Vice President and Chief Financial Officer,
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