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Arrow's LionHeart

This article was originally published in The Gray Sheet

Executive Summary

Phase I clinical trials evaluating fully implantable left-ventricular assist system (LVAS) for alternative-to-transplant indication expected to begin by March, firm reports following receipt of investigational device exemption approval. Five-site trial to include up to seven congestive heart failure patients who are not candidates for heart transplant and are refractory to drug therapy. Phase II studies are expected to begin by the end of the firm's fiscal year 2001 (ending Aug. 31, 2001). The firm expects to complete by September a 30 to 40-patient European study to support a CE mark
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