Transplantation
Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation
Published in Law and Health Weekly, May 10th, 2008
Thoratec Corporation (NASDAQ:THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said that it has received FDA approval of its PMA (PreMarket Approval) application, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure.
The approval follows a successful clinical trial involving more than 450 BTT patients, including those enrolled under Continued Access Protocols, and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel last November.
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