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

PLEASANTON, Calif., Jan. 20 /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 it has received FDA approval of its PMA (Pre-Market Approval) supplement, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) for Destination Therapy (DT).  

With this approval, the HeartMate II can be used to provide long-term cardiac support for patients suffering from advanced-stage heart failure who are not eligible for transplantation. Thoratec said it will begin the rollout of the device for the DT indication immediately and has sufficient inventory to address the expected increase in demand. The device was approved for Bridge-to-Transplantation (BTT) in the U.S. under the original PMA in April 2008.

The approval allows the HeartMate II to be used in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The PMA approval was based on a filing submitted in April 2009 that included two-year data on a pivotal study cohort of 200 randomized patients enrolled at 38 centers. Patients in the HeartMate II DT trial were randomized to the HeartMate II or the HeartMate® XVE—the only other device approved for DT—on a 2:1 basis, respectively. Patients in the pivotal cohort ranged in age from 26-81 years old, with a median age of 64 years. Also included in the primary analysis were data on 24 small BSA (body surface area) patients who because of their bod
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