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JARVIK HEART Announces FDA Conditional Approval of Trial Using the Jarvik 2000® Heart for Destination Therapy
Date:2/27/2012

NEW YORK, Feb. 27, 2012 /PRNewswire/ -- JARVIK HEART, Inc., a privately-held company that develops and manufactures cardiac assist devices, announced conditional FDA approval of its Pivotal Trial for evaluation of the Jarvik 2000® heart for destination therapy (DT). Use of the device for DT means that it will provide long-term, permanent support to end-stage congestive heart failure patients who are not candidates for heart transplant. The approval permits fifty medical centers to participate in the study. Each medical center may begin enrolling patients immediately upon approval by their Institutional Review Board.

(Photo: http://photos.prnewswire.com/prnh/20120227/NY60355)

Prior to full FDA approval of the trial, the company must submit additional information concerning statistical analysis and conduct of the study, as well as some additional engineering data.

The trial will randomize up to 350 study subjects to either the treatment group, in which patients receive the Jarvik 2000 intraventricular heart assist device, or the control group, in which patients receive the HeartMate® II left ventricular assist device (LVAD), the most widely used FDA-approved LVAD for DT. Patients will be followed for two years to assess primary endpoint success, generally defined as survival free of disabling complications. If the data analysis at two years, or at a prior interim analysis, establishes non-inferiority of the Jarvik 2000 compared to the control, the trial will be judged successful. Additionally, the patients will be followed for another year and the rates of serious infection related to the power cable and pump pocket will be analyzed for the three years since implant. Regarding device-related infection, the analysis is designed to determine if the Jarvik 2000 that uses a unique behind-the-ear power cable and has no pump pocket is superior to the HeartMate II, w
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SOURCE JARVIK HEART, Inc.
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