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Thoratec Announces FDA Approval To Commence REVIVE-IT Study Utilizing HeartMate II®

"REVIVE-IT will evaluate the use of the HeartMate II in heart failure patients currently not indicated for LVAD support.  These patients suffer from highly impaired quality of life and functional capacity, but their disease has not yet advanced to the point of more serious consequences, such as organ damage or immobility," stated Dr. Kormos from UPMC. 

The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health and Thoratec are sponsoring the REVIVE-IT study, through a $5 million contract from the NHLBI and a funding commitment of up to $11 million from Thoratec.  The NHLBI is providing executive and scientific guidance on the conduct of the study.

"We appreciate the leadership demonstrated by the NHLBI in this pioneering study, as well as our partnership with Thoratec," said Dr. Pagani.   "The HeartMate II device has been extensively studied for long-term support of advanced heart failure patients and has a very well-defined efficacy and safety profile.  We look forward to exploring its utilization and potential benefits, including extended survival and improved functional status, in earlier-stage patients."

In addition to REVIVE-IT, Thoratec maintains a firm commitment to the completion of the ongoing ROADMAP ( Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) study.  "ROADMAP and REVIVE-IT are complementary studies which together should advance the field's understanding of LVAD therapy in Class III and earlier-stage Class IV heart failure patients," stated David Farrar, Ph.D., Vice President, Research and Scientific Affairs at Thoratec.  ROADMAP is a post-market study of the HeartMate II, involving ambulatory advanced heart failure patients who are not yet dependent on intravenous inotropic support and are typically categorized as INTERMACS profiles 4-6, within the existing FDA-approved indication for Destination Therapy, whereas REVIVE-IT will include Class III patients currently not approved for LVAD support.  As of the end of 2012, 90 patients have been enrolled in ROADMAP, and Thoratec expects the full cohort of 200 patients to be enrolled by the end of 2013.

"Thoratec's mission is to advance the treatment of heart failure and the field of mechanical circulatory support.  To that end, we are pleased to partner with preeminent VAD programs across the U.S., under the leadership of the UM-CVC and UPMC, in the REVIVE-IT study," commented Gary F. Burbach, President and Chief Executive Officer of Thoratec.

For more information regarding the REVIVE-IT study, visit http://clinicaltrials.gov ID# NCT01369407.  Given the change in sponsorship of the study, however, some information on this website is subject to change, including information about the study device as well as the investigational sites that will be participating in the study.  For more information regarding the ROADMAP study, visit http://clinicaltrials.gov ID# NCT01452802.

About HeartMate II The HeartMate II is intended for a broad range of advanced heart failure patients and is the only continuous-flow left ventricular assist device (LVAD) approved by the FDA for both Bridge to Transplantation and Destination Therapy.  The device is designed to provide long-term cardiac support, pumping up to 10 liters of blood per minute for full support of the circulation, or to supplement the native function of the patient's left ventricle.  The HeartMate II is placed just below the diaphragm and is connected to the left ventricle, returning blood flow to the aorta, the main artery that carries oxygenated blood to the entire body.  With only one moving part, a continuously spinning rotor, HeartMate II is designed to provide exceptional reliability.  An external, wearable system that includes a small controller and two batteries is attached by a percutaneous driveline.  More than 200 peer-reviewed publications have featured studies regarding the HeartMate II, far exceeding the volume of published data on all other LVADs combined.  To date, over 13,000 patients have been implanted with the HeartMate II, including over 5,500 currently on support.

About ThoratecThoratec is the world leader in mechanical circulatory support with the broadest product portfolio to treat the full range of clinical needs for patients suffering from advanced heart failure. The company's products include the HeartMate LVAS and Thoratec VAD, with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures and distributes the CentriMag and PediMag / PediVAS product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit www.thoratec.com.

Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation and IVAD, Thoratec 360, Shared Care and Thoratec Connect are trademarks of Thoratec Corporation.  CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.

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