FDA approves bridge-to-transplant Levacor trial
This article was originally published in Clinica
WorldHeart has received unconditional approval from the US FDA to go ahead with its bridge-to-transplant (BTT) study of Levacor, its ventricular assist device. The trial will enrol 160 subjects, a reduction from the approximately 200 subjects of the original study plan. The Salt Lake City, Utah firm expects to implant the first device this quarter. Levacor is the only fully magnetically levitated, bearingless, implantable centrifugal pump to move into clinical trial, WorldHeart claims.
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