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NMT Medical study

This article was originally published in The Gray Sheet

Executive Summary

Enrollment in 1,600-patient pivotal trial to evaluate STARFlex septal repair implant to treat stroke and transient ischemic attack will commence following a meeting between FDA and company reps, slated for the end of March. Conditional clearance has been granted while the firm responds to follow-up questions. In September, NMT's device was deemed "not approvable" by an FDA panel due to study design issues (1"The Gray Sheet" Sept. 23, 2002, p. 14). In the new trial, half of patients will be treated with STARFlex and the other half will receive traditional medical therapy, NMT says...
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