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Thoratec Announces FDA Approval of HeartMate II(R) for Destination Therapy
Date:1/20/2010

y size could not be randomized to the larger HeartMate XVE. The filing also included data on adjunctive cohorts totaling an additional 409 patients, including those who had been originally supported by a HeartMate XVE, and based on the need for device replacement, elected to receive a HeartMate II, as well as patients enrolled under Continuous Access Protocols (CAPs).

"This is truly a momentous day for the hundreds of thousands of underserved advanced-stage heart failure patients," noted Gary F. Burbach, president and chief executive officer of Thoratec. "Those who now have access to the device owe a great deal to the patients and clinicians who participated in this landmark trial.

"As the data from both the trial and the BTT commercial experience with the device demonstrate, the HeartMate II is a proven therapy that extends patients' lives while providing them a significantly improved quality of life. We have been laying the groundwork for the DT launch through both our device manufacturing initiatives and market development programs targeted to clinicians and the 76 centers that have received certification from Centers for Medicare and Medicaid Services (CMS) for DT reimbursement. In addition, this approval will facilitate our initiatives to build upon our already strong presence in Europe," he added.

As a condition of approval, Thoratec has agreed to a post-approval study of 247 patients who will be followed until outcome or two years, whichever occurs first. Thoratec will utilize the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to collect the FDA-required data on outcomes, adverse events, functional status and quality of life. Thoratec has also agreed to conduct a second small study at three specific centers to collect data regarding the relationship between bleeding, thrombosis, von Willebrand syndrome and anticoagulation in
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SOURCE Thoratec Corporation
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