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Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)
Date:4/20/2009

over the past year has been very encouraging with respect to positive patient outcomes and increased adoption by the clinical community. We look forward to working with the FDA on this submission and hope to achieve DT approval by early 2010," he added.

The HeartMate II is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart failure patients. An implantable LVAS powered by a rotary pumping mechanism, the HeartMate II is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than a pulsatile device.

Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's product lines include the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS with more than 13,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division is a leader in point-of-care blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com or http://www.itcmed.com.

Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation, and IVAD is a trademark of Thoratec Corporation. ITC, A-VOX Systems, AVOXimeter, HEMOCHRON, ProTime and IRMA are registered trademarks of International Technidyne Corporation. CentriMag is a registered trademark of Levitronix LLC.

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SOURCE Thoratec Corporation
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