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

hich uses an abdominal cable and has an abdominal pump pocket.

The Jarvik 2000 has been used to treat late-stage heart failure in more than 500 patients in the United States, Europe, and Asia. The Jarvik 2000 model with the behind-the-ear connector has supported more than 200 patients in Europe for DT, including the longest survival of any heart assist device patient in the world, 7 1/2 years.

The bridge-to-transplant model of the Jarvik 2000 has a power cable that exits the abdominal wall—the same position used with the HeartMate II and HeartWare® VADs. The behind-the-ear cable, which will be used in this study, may have significant quality-of-life advantages over abdominal cables. It requires practically no care of the cable exit site and, unlike abdominal cables, does not require frequent redressing with sterile bandages that may require expensive home nursing. Jarvik 2000 patients with the behind-the-ear connector may shower and bathe normally and can even go swimming. In Europe, these patients have had low rates of infection, and there have been no failures of the internal cables and no mechanical failures of the Jarvik 2000 blood pump or its bearings. Long-term bench durability tests project high reliability of the device for ten years or more.

JARVIK HEART has also completed enrollment of the primary cohort of 150 patients in the US Bridge-to-Transplant Pivotal Study and is nearing completion of the follow-up period. Only two patients have yet to reach outcome.  The results in the study patients who received the most recent Jarvik 2000 model, using patented cone bearings, are expected to show a substantial improvement in the primary endpoint compared to the pin bearing design used earlier in the BTT study. Only cone bearings will be used in the DT trial.

JARVIK HEART is continuing research on new developments including child size and tiny infant size pumps with the support of the National Institutes of Health unde
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SOURCE JARVIK HEART, Inc.
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