WorldHeart plans VAD study at 10 U.S. centers
This article was originally published in The Gray Sheet
Executive Summary
FDA grants conditional approval for a U.S. bridge-to-transplant study of WorldHeart's Levacor ventricular assist device, a bearingless, fully magnetically levitated, implantable centrifugal pump. The Salt Lake City, Utah, firm says Aug. 20 that it is awaiting institutional review board approval at 10 clinical centers in the U.S.; WorldHeart eventually hopes to expand the study to 200 subjects