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Jarvik Heart, a New York-based maker of miniaturized heart assist devices announced Monday that the company has received regulatory approval for a clinical trial designed to test a ventricular assist device for end-stage heart failure patients.
The patients are those that are not candidates for an eventual heart transplant.
The 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 U.S. Food and Drug Administration-approved LVAD for DT,” the company said in a news release.
The patients will be followed for a period of two years to determine if they survive without debilitating complications.
The same device has been used in Europe to support 200 patients and has demonstrated its resilience through the longest survival of any heart assist device patient worldwide for 7 years, according to the company.
The ventricular-assist device market is dominated in the U.S. by Thoratec, followed closely by HeartWare, according to Piper Jaffray analyst Thom Gunderson. GlobalData estimates that market for ventricular assist devices will grow to $1 billion by 2017.