Thoratec Corporation (THOR) 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.
"With this BTT approval, we will now initiate our sales and marketing programs designed to place the HeartMate II in transplant centers that did not participate in the clinical trial. Our hope is to add about 40 new centers during the balance of the year, which would bring the total number of centers implanting the HeartMate II to approximately 80 centers," said Gary F. Burbach, president and chief executive officer of Thoratec.
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