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American Heart Association 2003 Scientific Sessions In Brief

This article was originally published in The Gray Sheet

Executive Summary

Arrow takes aim at Thoratec data: Adverse event rate associated with Arrow International's LionHeart left-ventricular assist device in the European Clinical Utility Baseline Study (CUBS) is comparable to Thoratec's HeartMate VE in the REMATCH trial, Arrow contends. Results of the destination LVAD therapy trial were presented by John Boehmer, MD, Pennsylvania State University, at the American Heart Association annual scientific sessions in Orlando Nov. 10. In CUBS, LionHeart was associated with 7.56 adverse events per patient-year, compared with 6.39 in REMATCH. Boehmer notes, however, that CUBS represents LionHeart's first clinical experience, while HeartMate had been implanted in 1,000 patients as a bridge to transplant prior to REMATCH (1"The Gray Sheet" June 30, 2003, In Brief)...
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