PLEASANTON, Calif., Nov. 30 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular disease, said today that the FDA Circulatory System Devices Advisory Panel has recommended unanimously that the agency approve, with conditions, the company's PMA (PreMarket Approval) allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT).
The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure.
"We are delighted with the panel's recommendation indicating their belief that the data demonstrate the safety and efficacy of the device. This represents a major step in our program to make this state-of-the-art circulatory support technology commercially available in the U.S. for patients suffering from advanced-stage heart failure," said Gary F. Burbach, president and chief executive officer of Thoratec. "We believe the data reflect the positive experience of patients in the trial and that the HeartMate II represents a significant breakthrough in the treatment of heart failure and look forward to continuing what has been to date a positive dialogue with the FDA around this submission and achieving approval," he added.
The leading clinical presenters were Dr. Leslie Miller, Walters Chair of Cardiovascular Medicine and Director of Cardiology Programs at Washington Hospital Center & Georgetown University Hospital, and Dr. Francis Pagani, Director, Heart Transplant Program, University of Michigan Hospital.
The conditions outlined in the panel's recommendations related to clarifications on labeling for the device regarding small patients and those unable to be treated with anti-coagulation therapy, and elements of the post-approval study.
An implantable LVAS powered by a rotary pumping mechanism, the HeartMate II 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 provides blood flow through the circulatory system on a continuous basis with only one moving part.
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 II 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://itcmed.com/.
Many of the preceding paragraphs, particularly but not excluding those addressing 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 "expects," "believes," "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 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 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.
