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Will Holly Graft go back to the drawing board?

This article was originally published in The Gray Sheet

Executive Summary

CABG Medical's drug-eluting artificial coronary artery bypass graft might need to be redesigned following an initial 35-patient arm of a clinical trial that failed to "meet the standards necessary to obtain regulatory product approvals," according to CEO Manny Villafana. In the study, in which patients were implanted with the graft and treated with aspirin and Plavix, 12 grafts occluded and became non-functional. The next enrollment arm will follow five graft-implanted patients, treated with warfarin and aspirin, for 60 days. If results are positive, a total of 30 patients will be followed for six months. A pivotal trial would still be necessary for FDA approval...

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