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This article was originally published in The Gray Sheet

Executive Summary

AbioCor replacement heart will be implanted in five patients to begin initial clinical trial of the destination therapy device, firm announces Jan 30. Endpoints are patient survival and quality of life (1"The Gray Sheet" Jan. 15, 2001, p. 3). While FDA granted an IDE for the implantation, the agency also has required Abiomed to respond to a series of questions within 45 days. Implantation will begin as soon as end-stage heart failure patients can be identified who are at risk for imminent death, are not transplantable and cannot be helped by other therapies

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