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Thoratec Says Interim Data Analysis Demonstrates Statistical Superiority for the HeartMate II(R) in Destination Therapy Trial
Date:12/4/2008

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 p
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SOURCE Thoratec Corporation
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