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Thoratec Announces FDA Approval Of HeartMate II® Pocket Controller™
, 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®
, 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 this therapy."
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 20th. 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 www.hearthope.com.
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.1 In 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 www.thoratec.com.
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 Switzerland GmbH.
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. 2012;5(2):241-248.
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