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
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Research In Brief
WorldHeart VAD study begins: Pivotal study of the Levacor ventricular assist device as a bridge to cardiac transplantation is under way, with the first successful implant occurring Jan. 13, according to WorldHeart. FDA granted conditional approval to begin the trial, which is ultimately expected to include 160 patients and 10 clinical sites, last August (1"The Gray Sheet" Aug. 24, 2009). Levacor is a bearingless, fully magnetically levitated, implantable centrifugal pump. Thoratec's HeartMate II and HeartMate XVE are the only left ventricular assist devices currently approved for bridge-to-transplant therapy. Thoratec announced last week it had received FDA approval for HeartMate II as a destination therapy, as well
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