Jarvik Heart Gets Green Light for Cardiac Device Trial
Posted on August 22, 2012 @ 09:48 am
Jarvik Heart Inc., a New York-based maker of miniaturized heart assist devices, has received U.S. Food and Drug Administration (FDA) approval for a clinical trial designed to test a ventricular assist device (VAD) for end-stage heart failure patients.
The RELIVE (Randomized Evaluation of Long-term Intraventricular VAD Effectiveness) pivotal trial will test the safety and efficacy of the Jarvik 2000 cardiac assist device over the long term and will be tested at 50 medical centers. The destination therapy 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 destination therapy (DT). DT is the treatment of a heart condition with no goal of eventual heart transplantation.
The Jarvik 2000 has been used to treat late-stage heart failure in more than 500 patients in the United States, Europe, and Asia, according to the company. 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, seven-and-a-half 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’s VADs. The behind-the-ear cable, which will be used in the DT 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 10 years or more.
The cardio device company also is working on child and tiny infant-size pumps with the support of the National Institutes of Health under the “PumpKIN Program”—Pumps for Kids, Infants, and Neonates. The company also is developing new cardiac assists devices intended to enhance patient quality of life.
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