PLEASANTON, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular disease, said today that more than 200 total patients have been enrolled in the worldwide clinical trial experience for the HeartMate II LVAS (left ventricular assist system), the company’s next generation ventricular assist device (VAD), which is currently in a Phase II pivotal trial.
The company also announced that it had received FDA approval to expand the number of centers participating in the Bridge-to-Transplantation (BTT) arm of the Phase II trial to 40 from the current 25. It expects the first of these centers to have institutional review board (IRB) approval during the current quarter.
As of January 6, 2006, 154 patients have been enrolled in just the Phase II portion of the U.S. trial. This includes 79 in the BTT arm and 75 in the Destination Therapy (DT) arm of Phase II.
“We continue to be very encouraged by the rate of enrollment in the pivotal Phase II trial and the potential of the HeartMate II to provide hemodynamic restoration therapy to patients suffering from late-stage heart failure. Since the beginning of the fourth quarter of 2005, we have enrolled 72 patients and our trial enrollment activity is far outpacing that of our previous trials or those involving other next generation devices,” said D. Keith Grossman, president and chief executive officer of Thoratec.
“There is a great deal of interest among clinicians in this device and the data from the Phase I trial that was presented at the recent 2005 Scientific Sessions of the American Heart Association. This data demonstrated the promising outcomes for both patient survival and quality of life that are achievable with the HeartMate II. In addition, receiving approval in November to CE Mark the device, allowing its commercial launch in Europe, was an important regulatory milestone,” he added.
The company’s U.S. Phase II study for the HeartMate II 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 either transplantation or 180 days of support. 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 DT arm provides for a two-year composite endpoint, which includes patient survival, rate of neurological events and device reliability.
“The protocol for the BTT arm of the Phase II trial calls for 133 patients, with follow up to either transplantation or six months of support. The ensuing analysis of the data and creation of our submission will take several weeks,” said Jeffrey Nelson, president of the company’s Cardiovascular Division.
“In parallel, we are evaluating the potential for including in the submission some portion of the Phase I BTT patients toward the 133 patient requirement. We may seek permission from the FDA to include these patients if we find that the data is comparable to that of the Phase II patients. In the meantime, we plan to file a Continued Access Protocol submission with the FDA that, if approved, would allow BTT patients to continue to receive the device once enrollment in the BTT arm is completed,” he added.
Thoratec Corporation is a world leader in hemodyanmic 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 more than 10,000 devices implanted in patients suffering from heart failure. Thoratec’s HeartMate XVE 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 and enrollment in 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; or media, Jennifer Chan ofFischerHealth, Inc., +1-310-577-7870, ext. 164, or jchan@fischerhealth.com,both for Thoratec Corporation
