Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Trans... ( COMPANY WILL INITIATE COMMERCIAL LAU...)

Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation

Date:4/21/2008

COMPANY WILL INITIATE COMMERCIAL LAUNCH PROGRAM TO ADD NEW CENTERS AND TO

INCREASE AWARENESS AMONG CARDIOLOGISTS

PLEASANTON, Calif., April 21 /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 (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.

"The HeartMate II is the first continuous flow device to receive FDA approval for this intended use in the U.S., representing a milestone in the treatment of advanced-stage heart failure patients and for the clinicians who treat them," said Gary F. Burbach, president and chief executive officer of Thoratec. "As our clinical trial indicated, the HeartMate II represents a new era in the treatment of advanced-stage heart failure with data demonstrating excellent survival rates, quality of life and functional capacity for a broad range of patients. This patient experience has created a high level of enthusiasm for the HeartMate II within the clinical community. We are hopeful that the device's trial experience, ease of implantation, small size and ability to provide longer duration support will result in broader adoption of mechanical circulatory support for the treatment of thes
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Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Trans...( COMPANY WILL INITIATE COMMERCIAL LAU...),Health