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Arrow LionHeart LVAD Trial Progress Supports 13% Stock Gain In February

This article was originally published in The Gray Sheet

Executive Summary

Continued clinical progress in the development of Arrow's LionHeart left ventricular assist device (LVAD) as a destination therapy helped sustain a 13.2% advance in the firm's stock price in February to $45.73

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Arrow International's board of directors will assess the future commercial potential of its left-ventricular assist devices at a meeting April 6-7

Arrow Contemplates Fate Of LVAD Business; WorldHeart, Thoratec Start Trials

Arrow International's board of directors will assess the future commercial potential of its left-ventricular assist devices at a meeting April 6-7

Arrow LionHeart

Preliminary data review of 25 patients implanted with the left ventricular assist system shows the device is associated with tangible improvements in quality of life and has yet to fail or cause infection, according to notified body TUV Munich. However, TUV believes 10-15 patients will need to be added over the next six months to compare Arrow's trial to Thoratec's seminal 67-patient REMATCH trial of the HeartMate VE, which is now considered the benchmark for all future LVAS trials (1"The Gray Sheet" April 15, 2002, p. 17). The LVAS system will probably receive its European CE mark in early 2003, instead of June 2002, as the company had first predicted, due to the change in trial protocol (2"The Gray Sheet" March 11, 2002, p. 16)...

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