Healthcare Industry News: HeartMate II
News Release - August 15, 2007
Thoratec Announces HeartMate II(R) PMA Will be Reviewed by FDA Advisory PanelPLEASANTON, Calif., Aug. 15 (HSMN NewsFeed) -- Thoratec Corporation (Nasdaq: THOR ), a world leader in products to treat cardiovascular disease, said today that its PMA (PreMarket Application) seeking approval of its HeartMate II for bridge-to-transplantation will undergo review by an FDA advisory panel later this year.
The company said that it has been informed by the FDA that the tentative date for the review by a Circulatory Systems Device Advisory Panel is November 30, 2007.
Recently, the company announced it had filed an amendment to its PMA the week of July 23rd that it believed addressed all of the significant deficiencies outlined by the FDA in its comment letter. The company also announced that it has now responded to all outstanding questions raised in the FDA's comment letter.
Thoratec is a world leader in therapies to address advanced stage heart failure. The company's product lines include the Thoratec VADŽ (Ventricular Assist Device) and HeartMate 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 websites at http://www.thoratec.com or http://www.itcmed.com.
This press release contains forward-looking statements, including but not exclusively those addressing future performance or timelines and milestones for clinical trials 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," "projects," "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 the development of new markets including Destination Therapy, the growth of existing market for our products, customer and physician acceptance of Thoratec products, the results of enrollment in and timing of clinical trials, including for the HeartMate II, the ability to improve financial performance, regulatory approval process, the effects of healthcare reimbursement and coverage policies 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.
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