FDA Panel Review Of J&J Cypher Stent Will Weigh SIRIUS Late Loss Data
This article was originally published in The Gray Sheet
Executive Summary
Johnson & Johnson/Cordis' upcoming presentation before an FDA advisory panel on the Cypher drug-eluting stent will highlight a 67% reduction of target vessel failure (TVF) at nine months compared with bare stents
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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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