FDA Approves Jarvik 2000 Pivotal Trial
Jarvik Heart, a developer of advanced technology for the treatment of heart failure, announced that it has received conditional approval to begin a pivotal trial of the Jarvik 2000 FlowMaker for bridge-to-transplant use. The study will enroll up to 160 patients at 25 medical centers throughout the U.S. The primary endpoint of the study will be successful bridging to heart transplant or survival for six months supported by the device.
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