Thoratec Announces FDA Approval Of HeartMate II® Pocket Controller™
PLEASANTON, Calif., May 17, 2013
PLEASANTON, Calif., May 17, 2013 /PRNewswire/ --Thoratec Corporation (NASDAQ:
THOR), a world leader in device-based mechanical circulatory support therapies
to save, support and restore failing hearts, today announced that it has
received approval from the U.S. Food and Drug Administration (FDA) to market
the HeartMate II^® Pocket Controller™, the small, smart, safe face of the
HeartMate II LVAD System.
"In offering HeartMate II LVAD patients our next-generation Pocket Controller
device, we are providing a product that has been extensively tested and is
designed for greater ease of use and safety," said Gary F. Burbach, President
and Chief Executive Officer. "We have a significant amount of clinical
experience and patient feedback from Europe that has highlighted the Pocket
Controller's ability to deliver meaningful benefits in everyday living with
The Pocket Controller is designed to support the active lifestyles that
patients with HeartMate II LVADs are leading. The Pocket Controller is
lighter and more compact than previous LVAD system controllers, and it
features an intuitive user interface with enhanced information content.
Additionally, with a single-side cable design, the device can slide easily and
discreetly into a front pocket. The Pocket Controller has also been designed
to promote patient safety, through features including prioritized visual
alarms, on-screen instructions, and a backup battery, which can provide at
least 15 minutes of full power during periods of inadvertent disconnections
from power sources.
"Patients are living for extended periods of time on HeartMate II support,
either while they wait for a transplant or as a long-term, destination
therapy," noted Burbach. "The launch of the Pocket Controller provides an
attractive option for these patients and advances Thoratec's mission, which is
to improve the lives of individuals suffering from advanced heart failure."
Thoratec will begin training U.S. implanting centers on the Pocket Controller
during the week of May 20^th. Following clinician training, the Pocket
Controller will be available for new patients as well as for current HeartMate
II patients eligible to upgrade their existing system controllers. Patients
should contact their centers to learn more about the HeartMate II system and
the new Pocket Controller. To find an implant center near you, please visit
About HeartMate II
HeartMate II is the most widely used and extensively studied LVAD in the
world. Featuring innovative design elements, including proprietary textured
surfaces, blood immersed ruby bearings and open flow paths, HeartMate II has
proven to be a highly durable device capable of long-term circulatory
support.^1In clinical testing, over 80 percent of HeartMate II recipients
became virtually free of heart failure symptoms shortly after implant and
sustained those improvements for the full two-year follow-up period.^2
Moreover, controlled clinical trials as well as large-scale commercial
experience have demonstrated significant improvement in patients' functional
capacity, with 94 percent of HeartMate II recipients able to perform the
6-minute walk test after six months of support. ^3,4 Overall, many patients
report returning to active living, with meaningful improvements in their
quality of life. To date, over 14,000 patients have been implanted with
HeartMate II, including over 6,000 currently on support.^5 HeartMate II is the
only continuous-flow LVAD approved by the FDA for both
Bridge-to-Transplantation and Destination Therapy, or permanent support.
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
distributes 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 Pocket Controller and IVAD are
trademarks of Thoratec Corporation. CentriMag and PediMag are registered
trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec
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.
^1 Reichenbach SH, Masterson KB, Butler KC, Farrar DJ. Negligible bearing wear
in explanted HeartMate II LV ADs following clinical support for up to 4 years.
Paper presented at: Proceedings of the Annual Meeting of the International
Society of Rotary Blood Pumps; October 14-15, 2010; Berlin, Germany.
^2 Park SJ, Milano CA, Tatooles AJ, et al; for the HeartMate II Clinical
Investigators. Outcomes in advanced heart failure patients with left
ventricular assist devices for destination therapy. Circ Heart Fail.
^3 John, Naka, Smedira, et al. Ann Thorac Surg 2011;92:1406-13.
^4 Rogers, Aaronson, Boyle, et al. JACC 2010;55:1826-34.
^5 Data on file as of May 2013.
SOURCE Thoratec Corporation
Contact: Karin Pellmann for Thoratec Corporation, +1-646-515-6933,
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