PLEASANTON, Calif., Nov. 30 Thoratec Corporation(Nasdaq: THOR), a world leader in products to treat cardiovascular disease,said today that the FDA Circulatory System Devices Advisory Panel hasrecommended unanimously that the agency approve, with conditions, thecompany'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-termcardiac support for advanced-stage heart failure.
"We are delighted with the panel's recommendation indicating their beliefthat the data demonstrate the safety and efficacy of the device. Thisrepresents a major step in our program to make this state-of-the-artcirculatory support technology commercially available in the U.S. for patientssuffering from advanced-stage heart failure," said Gary F. Burbach, presidentand chief executive officer of Thoratec. "We believe the data reflect thepositive experience of patients in the trial and that the HeartMate IIrepresents a significant breakthrough in the treatment of heart failure andlook forward to continuing what has been to date a positive dialogue with theFDA around this submission and achieving approval," he added.
The leading clinical presenters were Dr. Leslie Miller, Walters Chair ofCardiovascular Medicine and Director of Cardiology Programs at WashingtonHospital 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 toclarifications on labeling for the device regarding small patients and thoseunable to be treated with anti-coagulation therapy, and elements of thepost-approval study.
An implantable LVAS powered by a rotary pumping mechanism, the HeartMateII is significantly smaller than currently approved devices, enabling aneasier implantation in a broader population of patients. The HeartMate II isdesigned to have a much longer functional life than other approved devices andto operate more simply and quietly. The device provides blood flow through thecirculatory system on a continuous basis with only one moving part.
Thoratec Corporation is a world leader in hemodynamic restorationtherapy-developing products to treat cardiovascular disease. The company'sproduct line includes the Thoratec(R) VAD (Ventricular Assist Device) andHeartMate II LVAS with more than 11,000 devices implanted in patientssuffering from heart failure. Additionally, its International TechnidyneCorporation (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 thoseaddressing future performance, contain forward-looking statements within themeaning of Section 27A of the Securities Act of 1933 and Section 21E of theSecurities Exchange Act of 1934. These statements can be identified by thewords "expects," "believes," "could," "will," and other similar words. Actualresults, events or performance could differ materially from theseforward-looking statements based on a variety of factors, many of which arebeyond Thoratec's control. Therefore, readers are cautioned not to put unduereliance on these statements. Investors are cautioned that all such statementsinvolve risks and uncertainties, including risks related to the results ofenrollment in and timing of clinical trials, including the HeartMate II,regulatory approval processes, the development of new markets, includingDestination Therapy, the growth of existing markets for our products, customerand physician acceptance of Thoratec products, and the effects of healthcarereimbursement and coverage policies. Forwa