, Dec. 11, 2012
/PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, announced today that the company has received approval from Japan
's Ministry of Health, Labour and Welfare to market HeartMate II®
as a Bridge-to-Transplantation therapy for patients suffering from advanced heart failure.
"Approval in Japan marks a significant milestone in Thoratec's efforts to disseminate HeartMate II to advanced heart failure patients worldwide," said Gary F. Burbach, President and Chief Executive Officer. "We are enthusiastically preparing to launch HeartMate II into this important market."
To support Japanese approval, Thoratec and its distribution partner, Nipro Corporation, conducted a confirmatory clinical study, which enrolled six patients at five institutions. At over two years of follow-up, all six patients are alive, with three having been transplanted and the other three still supported by the device. "We have been highly encouraged by the performance of HeartMate II in Japan, and we look forward to working closely with clinicians and Nipro to foster continued excellent clinical outcomes," added Burbach.
Thoratec and Nipro anticipate a commercial launch of HeartMate II toward the end of the first quarter of 2013, after centers have been trained and reimbursement is in place. The initial launch will target approximately 15 hospitals, including the clinical trial centers as well as additional institutions that are already accredited to perform ventricular assist device (VAD) implant procedures. Nipro will have dedicated personnel in the field, trained on HeartMate II, to provide sales, marketing and clinical support for the launch. Thoratec will conduct all initial surgical training and will support Nipro with additional resources as necessary.
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 www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation and IVAD is a trademark 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, particularly but not exclusively those addressing guidance for fiscal 2012 financial results or future performance 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," 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, including development and clinical trial timing, and new markets including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of FDA and Japanese regulatory requirements, our ability to address issues raised by FDA or Japanese regulatory inspections adequately and on a timely basis without a resulting recall of products or interruption of manufacturing or shipment of products, the effects of healthcare reimbursement and coverage policies, 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