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This article was originally published in The Gray Sheet
Approval of a "bridge-to-transplant" indication for the BVS-5000 device has never been sought by the company, as was reported in "The Gray Sheet" (1Aug. 30, p. 11). The device is approved for temporary cardiac support for post-cardiotomy shock, cardiac transplant failure, myocarditis, and right-ventricular assist while the patient is on an implantable left ventricular assist device
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