PLEASANTON, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular disease, said today that it has received approval to CE Mark its HeartMate II LVAS (Left Ventricular Assist System), allowing the commercial launch of the device in Europe. The company said it expects to initiate product sales activities in the market before the end of the year.
The HeartMate II is a next generation cardiac assist device designed to provide long-term support for patients in advanced-stage heart failure. The HeartMate II is currently undergoing a Phase II pivotal clinical trial in the U.S. for both Destination Therapy (DT) and Bridge-to-Transplantation (BTT).
“We are delighted to have achieved this important regulatory approval, resulting from our submission some seven months ago. It is the result of the first rigorous regulatory assessment of our next-generation technology and provides further validation for the HeartMate II’s performance and its very positive phase I clinical trial experience,” noted D. Keith Grossman, president and chief executive officer of Thoratec.
The regulatory application for European approval was based on data from the first 20 patients implanted in the company’s Phase I U.S. trial and in a European study. Patients enrolled in the entire pilot study population accounted for more than 7,900 days of cumulative support, with each supported from 1 day to 717 days.
As of October 21, 2005, 153 total patients have been enrolled in the worldwide HeartMate II trial experience, including 102 patients in the company’s U.S. Phase II pivotal trial. This includes 52 in the BTT arm and 50 in the DT arm of the Phase II trial. Excluding control arm patients, 143 patients have now been implanted with the HeartMate II.
“The HeartMate II has generated a high level of interest among clinicians in Europe due to the positive patient experience and ease of implant. With this approval, we now have four cardiac assist devices approved for sale in Europe, enabling us to offer clinicians both short and long-term treatment options for patients with heart failure,” said Jeffrey Nelson, president of Thoratec’s cardiovascular division.
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 current FDA approved HeartMate XVE device. The HeartMate II is designed to have a much longer functional life than currently approved pulsatile 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.
The company’s U.S. Phase II study for the device includes both a BTT and DT arm, the first time the FDA has approved a clinical trial with both indications in one protocol. The BTT arm will involve 133 patients in total, with the primary endpoint being the rate of survival to transplantation, or 180 days. The DT arm of the study will involve 200 total patients, randomizing the HeartMate II to the company’s HeartMate XVE on a 2-1 basis, respectively. The study provides for a composite two-year endpoint, which includes patient survival, rate of neurological events and device reliability.
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 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 & Co., +1-415-397-2686, or media, Jennifer Chan ofFischerHealth, Inc., +1-310-577-7870, ext. 164, or jchan@fischerhealth.com
Web site: http://www.thoratec.com/
