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CHF Device Trial Endpoints Clarification From FDA Requested

This article was originally published in The Gray Sheet

Executive Summary

Thoratec's REMATCH trial of the HeartMate VE left ventricular assist device, designed to demonstrate improved survival versus optimal medical management, will not be generalizable to most congestive heart failure device trials, according to Mehmet Oz, MD, Columbia University

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Who’s In Control? Thoratec, Investigators Discuss Access To NIH-Funded Data

Thoratec is in negotiations with NIH to restrict access to control group data from the REMATCH randomized trial of the HeartMate VE upon the study's completion

Who’s In Control? Thoratec, Investigators Discuss Access To NIH-Funded Data

Thoratec is in negotiations with NIH to restrict access to control group data from the REMATCH randomized trial of the HeartMate VE upon the study's completion

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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