PLEASANTON, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular disease, said today a presentation on data from the bridge-to-transplantation (BTT) arm of its HeartMate II pivotal study has been accepted for a late-breaking clinical trial session of the 2007 American College of Cardiology Scientific Sessions (ACC) in New Orleans.
The presentation by Dr. Leslie Miller of Washington Hospital Medical Center/Georgetown University on behalf of the HeartMate II investigators, will take place at 11:30 a.m., Tuesday, March 27.
Enrollment in the BTT arm of the trial was completed in May 2006, and the company completed its PreMarket Approval (PMA) filing seeking approval for the bridge indication at the end of 2006.
“The fact that this presentation has been accepted for a late-breaking clinical trial session suggests a high level of interest in the study of this new technology among members of the cardiology community. The data from the pilot study was encouraging with respect to device performance and patient outcomes. Given their enthusiastic response to those results, we believe that the clinical community is looking forward to hearing a more complete review from the pivotal trial,” said Gary F. Burbach, president and chief executive officer of Thoratec.
Enrollment of BTT patients continues in the study under a Continued Access Protocol. As of October 26, 2006, the company had enrolled 220 bridge patients. The trial also includes a Destination Therapy (DT) arm, in which 196 patients had been enrolled as of October 26, 2006. The company will provide updated enrollment information during its fourth quarter earnings conference call on Thursday, February 15.
The HeartMate II, which has a CE mark allowing for its commercial sale in Europe, is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS (Left Ventricular Assist System) powered by a rotary pumping mechanism, it is significantly smaller than currently approved devices, enabling an easier implantation in a broader population of patients. The HeartMate II is designed to have a much longer functional life than other approved devices and to operate more simply and quietly. The device pumps blood through the circulatory system on a continuous basis with only one moving part.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company’s product lines include the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS 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 excluding those addressing clinical trial data and product approvals, 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 “expects,” “believes,” “could,” 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 results of enrollment in and timing of clinical trials including the HeartMate II, regulatory approval processes, the development of new markets, including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, and the effects of healthcare reimbursement and coverage policies. 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 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.
Thoratec Corporation
CONTACT: David Smith, Executive Vice President, Chief Financial Officer ofThoratec Corporation, +1-925-847-8600; or Neal Rosen of Kalt Rosen & Co.,+1-415-397-2686, for Thoratec Corporation
Web site: http://www.thoratec.com/
