This article was originally published in The Gray Sheet
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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