Published in Medical Letter on the CDC and FDA, August 14th, 2005
The pivotal study is designed to establish the safety and efficacy of the Jarvik 2000 in supporting severe heart failure patients while they await the availability of a donor heart for transplant. Up to 160 patients will be enrolled in the study at 25 medical centers throughout the United States. Presently, Jarvik Heart has 9 trained implant centers and will add 16 additional implant teams...
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