PLEASANTON, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular disease, said today that its International Technidyne Corporation (ITC) division has received a Warning Letter from the U.S. Food and Drug Administration (FDA) stating concerns about ITC's quality systems and specifically related to certain production lots of its ProTime System anticoagulation monitoring device.
The company said the Warning Letter relates to manufacturing and quality control issues involving a component from an outside supplier that could cause specific lots of the system to deliver error messages on the display instead of test results and/or the remote possibility of incorrect readings of patient blood coagulation levels.
ITC is scheduled to meet with FDA to discuss the Warning Letter and ITC's responses and believes that part of its corrective action will involve a voluntary recall of certain lots of its ProTime system, involving approximately 5,800 of the devices. ITC is not aware of any patient-related issues related to this matter. The company said that it believes the issue has been addressed and should not affect any future ProTime System shipments.
Management estimated that the cost of the product recall will be in the range of $0.5 million to $1.0 million and accordingly indicated that the company believes that this matter will have no impact on the company's financial guidance for fiscal 2007.
Thoratec is a world leader in therapies to address advanced stage heart failure. The company's product lines include the Thoratec VAD(R) (Ventricular Assist Device) and HeartMate(R) LVAS (Left Ventricular Assist System) with more than 11,000 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 http://www.thoratec.com or http://www.itcmed.com.
Many of the preceding paragraphs, particularly but not exclusively those addressing ITC product activities, fiscal guidance for 2007 financial results, and future performance contain forward-looking statements within the meaning of Section 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," "expects," "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 decisions, the growth of existing markets for our products, changes in the mix of existing markets for our products and related gross margin for such product sales, the ability to improve financial performance, regulatory approval processes, the effects of healthcare reimbursement and coverage policies, the effects of seasonality in Thoratec products sales, the effects of price competition from any Thoratec competitors and the effects of any merger and acquisition related activities. 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.
CONTACT: David Smith, Executive Vice President, Chief Financial Officer of
Thoratec Corporation, +1-925-847-8600; or Neal Rosen of Ruder-Finn,
+1-415-692-3058, for Thoratec Corporation
Web site: http://www.thoratec.com/
http://www.itcmed.com/
