Cardiology

U.S. FDA grants full approval to conduct a pivotal trial of the Jarvik 2000

Published in Medical Letter on the CDC and FDA, August 14th, 2005

Jarvik Heart, Inc., a developer of technology for the treatment of heart failure, announced that it has received full approval from the U.S. Food and Drug Administration (FDA) to begin a pivotal trial of its mechanical heart, the Jarvik 2000 FlowMaker, for bridge-to-transplant use.

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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Source: Medical Letter on the CDC and FDA (2005-08-14)

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