PLEASANTON, Calif., Dec. 4 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that a pre-specified interim analysis of data from its HeartMate II Destination Therapy (DT) pivotal trial shows that patients implanted with the device achieved statistically superior outcomes versus those in the control group who were implanted with the company's HeartMate XVE. The DT study protocol called for an interim analysis to test for overwhelming superiority when 67 percent of the first 200 randomized patients had reached two-years of follow up. The primary endpoint for the trial assessed in this analysis includes patients being alive, and free of stroke and the need of reoperation for device replacement at two years.
As a result of the data, the study's Data Safety Monitoring Board (DSMB) has concurred with Thoratec's plan to eliminate randomization for all additional patients enrolled in the DT study under the FDA-authorized Continuous Access Protocol (CAP). The company indicated that it will be filing an Investigational Device Exemption (IDE) Supplement with the FDA seeking approval for this action later this month, and that it now expects to file a PreMarket Approval (PMA) application seeking commercial approval of the HeartMate II for DT in the first half of 2009.
In May 2007, the company announced that it had achieved the required enrollment of 200 patients in the randomized portion of the trial. Since then, the company has continued to enroll patients under CAPs, including the most recent CAP approved by the FDA in mid-November allowing for enrollment of an additional 60 patients. As of October 24, 2008, the company had enrolled 607 patients in the trial, including 366 in the randomized portion of the study.
"This is tremendous news for patients suffering from advanced-stage heart failure and the clinicians who treat them. The data indicate that the HeartMate II achieved statistical superiority to the control group patients by an overwhelming margin. These findings complement the experience with the device in bridge-to-transplantation (BTT) patients, both in our pivotal trial and as a commercially available device since receiving FDA approval in April," noted Gary F. Burbach, president and chief executive officer.
"We are now in the process of providing the conclusions from this analysis to our clinical investigators and the FDA, and would hope to see the initial public presentation of data from the trial soon after we file our PMA. As is always the case, the FDA must review and confirm our findings. We will initiate this process with our request to end randomization in the ongoing DT trial later this month. We are extremely gratified to report this clinical trial milestone which is a tribute to the clinicians and centers participating in the study, as well as the entire team at Thoratec," he added.
The HeartMate II is a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients. A continuous flow device, the HeartMate II can pump up to 10 liters of blood per minute and is designed to provide long-term cardiac support. The device is implanted alongside a patient's native heart and takes over the pumping ability of the weakened heart's left ventricle. It is easier to implant than prior devices, and with only one moving part, the HeartMate II is designed to provide exceptional reliability and improved patient quality of life. The device is designed to have a much longer functional life than the previous generation of devices and to operate more simply and quietly.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's product lines include the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS with more than 12,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies point-of-care 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.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation. ITC, is a registered trademark of International Technidyne Corporation.
Many of the preceding paragraphs, particularly but not exclusively those addressing future performance or timelines and milestones for clinical trials, contain forward-looking statements within the meaning of the 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, "believes," "views," "expects," "plans," "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 development of new markets including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, changes in the mix of existing markets for our products and related gross margin for such product sales, the results of enrollment in and timing of clinical trials, including the HeartMate II, the effects of FDA regulatory requirements, 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 "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.
|SOURCE Thoratec Corporation|
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