DALLAS, Nov. 14 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular disease, said today that the first major presentation of data from the Phase I trial for its HeartMate II LVAS (left ventricular assist system) demonstrates encouraging results in terms of both patient survival and quality of life.
The HeartMate II Axial Flow Left Ventricular Assist Device: Suitability for Advanced Congestive Heart Failure (AOP.80.1) was presented today at the 2005 Scientific Sessions of the American Heart Association (AHA). The multi- center data covered 34 patients with a median duration of support of 160 days, with support ranging from six to 562 days.
Presented by Dr. Robert L. Kormos of the University of Pittsburgh Medical Center, the study showed there were no device-related deaths, no pump failures and only two driveline infections. Of the 14 patients who were supported for more than three months, 43 percent improved three functional classes on the New York Heart Association (NYHA) classification system of heart failure and another 43 percent improved one to two functional classes. In addition, three- quarters of the patients could exceed walking distances prior to the implant after being supported by the device for three months.
“This study demonstrates the promising outcomes for both patient survival and quality of life that are possible to achieve with the HeartMate II,” said Keith Grossman, president and chief executive officer of Thoratec. “The study also noted a low rate of pump-related infections and that the device is suitable for a broader range of body sizes than the HeartMate XVE,” he added.
“This data demonstrates the ability of the HeartMate II to restore hemodynamic function resulting in significant improvement in functional classification,” said Jeffrey Nelson, president of the company’s Cardiovascular Division. “Ultimately, this should enable us to reach a wider range of advanced-stage heart failure patients and offer significant survival benefits as well as improved quality of life,” he added.
Last week, the company announced that it had received approval to CE Mark the HeartMate II, allowing the commercial launch of the device in Europe. Patient enrollment in its Phase II pivotal U.S. trial for the device had reached 102 patients as of the company’s October 21, 2005 third quarter earnings conference call. This included 52 patients in the bridge-to- transplantation (BTT) arm and 50 in the Destination Therapy (DT) arm. In total, 153 patients have now been enrolled in the worldwide HeartMate II trial experience.
The HeartMate II is a continuous flow device designed to provide long-term cardiac support for patients who are in advanced-stage heart failure. An implantable LVAS powered by a rotary pumping mechanism, it is approximately one-fifth the size of the company’s currently FDA approved HeartMate XVE. 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 provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than pulsatile devices.
Another study presented at AHA reviewed the impact of patient selection factors on survival for patients implanted with a HeartMate XVE for permanent support. The data covered 195 patients who received the device between November 2001 and March 2005. It found that LVAD patients who were at greatest risk for early mortality were those whose preoperative conditions included heart failure severity, renal dysfunction, poor nutrition and preexisting inflammation, infection and coagulation abnormalities. It noted that better patient selection and education on established advanced practice guidelines, as well as appropriate timing of device implantation, are critical to assuring successful outcomes.
Thoratec Corporation is a world leader in hemodynamic restoration therapy -- developing products to treat cardiovascular disease. The company’s product line includes the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS, with nearly 10,000 devices implanted in patients suffering from heart failure. Thoratec’s HeartMate LVAS is the first and to date only FDA-approved device for Destination Therapy, or the permanent support of late-stage heart failure patients who are not eligible for heart transplantation. Thoratec’s product line also includes the Vectra(R) vascular access graft (VAG) for patients undergoing hemodialysis. 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 guidance for future performance or timeliness and milestones for clinical trials, 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,” “projects,” “hopes,” “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 development of new markets including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products including the HeartMate II, the results of clinical trials including the HeartMate II, regulatory approval processes, the effects of healthcare reimbursement and coverage policies, the continued release of favorable clinical data, 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, “Factors That May Affect Future Results,” in Thoratec’s most recent annual report on Form 10-K and quarterly report on Form 10-Q. 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.
Thoratec Corporation
CONTACT: Investors: Cynthia Lucchese, Senior Vice President, ChiefFinancial Officer, of Thoratec Corporation, +1-925-847-8600, or Neal Rosenof Kalt Rosen & Company, +1-415-397-2686, for Thoratec Corporation; orMedia: Jennifer Chan of FischerHealth, Inc., +1-310-577-7870, ext. 164, orjchan@fischerhealth.com, for Thoratec Corporation
Web site: http://www.thoratec.com/
