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Thoratec Reports 34 Percent Increase in 2008 Revenues
Date:2/5/2009

er of 2008, ending 2008 with 55 new centers and a total of 101 centers in North America.

Thoratec said it received approval from the FDA at the end of 2008 to end randomization in its Destination Therapy (DT) pivotal clinical trial for the HeartMate II. In early December, 2008, the company announced that a pre- specified interim analysis of data from the trial showed that patients implanted with the HeartMate II achieved statistically superior outcomes versus those in the control group who were implanted with the company's HeartMate XVE. As a result, the study's Data Safety Monitoring Board concurred with Thoratec's plan to eliminate randomization for all additional patients enrolled in the DT study under FDA-authorized Continued Access Protocols. The company plans to file its PreMarket Approval (PMA) seeking FDA approval of the HeartMate II for DT in late May of this year, leading to an expected approval in the first half of 2010. As of January 23, 2009, there were 648 patients enrolled in the DT arm of the trial.

"While 2008 was a year of great accomplishment, we have ambitious goals for 2009 that will further our presence in the heart failure arena," Burbach noted. "These include achieving growing penetration with the HeartMate II and the continued addition of VAD therapy at a number of open-heart centers. Most importantly, we will be driving toward a DT approval with the filing of our PMA and subsequently releasing data from the pivotal clinical trial at a major cardiology conference in the fall.

"In addition," he continued, "we are looking to increase our international presence for the HeartMate II, particularly in Europe, and will lay the groundwork for a future entry into Japan. We also have important milestones in our product development programs, which strongly support the launch of the HeartMate II for DT in 2010. These include new external peripherals for the HeartMate II to enhance pati
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SOURCE Thoratec Corporation
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