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Study Data Show Positive European Experience With DuraHeart Left Ventricular Assist Device for Advanced Stage Heart Failure Patients
Date:4/7/2009

Sustained Benefits for Patients Awaiting Transplantation

ANN ARBOR, Mich., April 7 /PRNewswire/ -- The DuraHeart(TM) Left Ventricular Assist System (LVAS) shows sustained benefits in providing safe and reliable long-term circulatory support with an improved survival rate and an acceptable adverse event rate in advanced heart failure patients who were eligible for transplantation. These conclusions, based on the European experience with DuraHeart, the first active magnetically levitated centrifugal left ventricular assist system, are published on line in the European Journal of Cardio-thoracic Surgery (EJCTS) at http://dx.doi.org/10.1016/j.ejcts.2008.12.033.

The European experience includes 68 patients who received the DuraHeart Left Ventricular Assist System between January 2004 and July 2008 including 33 patients treated as part of the European multi-center clinical trial (Germany, Austria, and France) and 35 patients treated in the post-trial period. All patients were classified with end-stage heart failure and were on approved lists to receive donor hearts (Bridge to Transplant). The trial sponsor was Terumo Heart, Inc., maker of the DuraHeart System and a wholly owned subsidiary of Terumo Corporation.

"In a patient population with advanced disease at imminent risk of death due to end-stage left ventricular failure and eligible for heart transplantation, the DuraHeart was safe and performed as intended," said Michiel Morshuis, M.D. Senior Physician, Clinic for Thoracic and Cardiovascular Surgery at the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen. "We believe the device may have potential for long-term circulatory support not only as a bridge to transplant, but also for destination therapy."

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SOURCE Terumo Heart, Inc.
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