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This article was originally published in The Gray Sheet

Executive Summary

Severe abdominal bleeding unrelated to the firm's AbioCor artificial heart caused the death of the first device recipient Nov. 30 after 151 days of use as part of an ongoing U.S. clinical trial, the firm states. Previous anticoagulant treatment also contributed to the death of the sixth AbioCor recipient from uncontrolled bleeding on Nov. 28. FDA cleared expansion of the trial from five to 10 patients on Nov. 26. Under the original IDE agreement, the U.S. AbioCor trial is expected to include three groups of five patients. The company expects to file a PMA in 2003...

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